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MarketScreener Homepage  >  Equities  >  London Stock Exchange  >  AstraZeneca PLC    AZN   GB0009895292

ASTRAZENECA PLC

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AstraZeneca : Full-year and Q4 2019 results clinical trials appendix

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02/14/2020 | 03:39am EST

Clinical trials appendix FY 2019 results update

Movement since Q3 2019 update

New to Phase I

New to Phase II

New to Pivotal Study

New to Registration

NME

NME

Lifecycle Management

NME

AZD0466

AZD9833

Fasenra MANDARA

selumetinibSPRINT 1

BCL2/xL haematalogical and solid tumours

selective oestrogen receptor degrader oestrogen receptor

IL5R mAb eosinophilic granulomatosis with polyangiitis

MEK inhibitor paediatric neurofibromatosis type-1

+ve breast cancer

AZD2693

Additional indication

NASH resolution nonalcoholic steatohepatitis

cotadutide

Imfinzi#+/- tremelimumab + SoC CASPIAN 1

GLP-1 / glucagon dual agonist nonalcoholic steatohepatitis

PD-L1 mAb +/- CTLA-4 mAb + SoC 1st-lineES-SCLC

AZD4041#

orexin 1 receptor antagonist opioid use

MEDI3506

Lifecycle Management

disorder

IL33 mAb diabetic kidney disease

Farxiga3DAPA-HF1

SGLT2 inhibitor worsening HF or CV death in patients with chronic HF

MEDI0618

MEDI5752

(HFrEF)

PAR2 antagonist mAb osteoarthritis pain

PD-1/CTLA-4 bispecific mAb solid tumours

Lynparza#PROFOUND 1

MEDI5395

Additional indication

PARP inhibitor prostate cancer

rNDV GMCSF solid tumours

MEDI3506

IL33 mAb atopic dermatitis

Symbicort SYGMA1

ICS/LABA as-needed use in mild asthma

Removed from Phase I

Removed from Phase II

Removed from Phase III

Removed from Registration

NME

NME

NME

MEDI7247

Epanova STRENGTH

Enhertu(trastuzumab deruxtecan)DESTINY-Breast012

ASCT2 antibody drug conjugate

omega 3 carboxylic acids CV outcomes trial in statin

HER2 targeting antibody drug conjugate HER2-Positive, Unresectable

haematological malignancies and solid tumours

treated patients at high CV risk, with persistent

and/or Metastatic Breast Cancer Subjects Previously Treated With T-

hypertriglyceridaemia plus low HDL cholesterol

DM1

oleclumab+AZD4635#

CD73 mAb + A2aR inhibitor EGFRm NSCLC

Lifecycle Management

Calquence#ASCEND2

BTK inhibitor relapsed/refractory chronic lymphocytic leukaemia

Calquence#ELEVATE-TN2

BTK inhibitor 1st-line chronic lymphocytic leukaemia

Lynparza#POLO2

PARP inhibitor pancreatic cancer

2

¶ Registrational Phase II/III study #Partnered and/or in collaboration 1

Submission Accepted 2Submission Approved 3Farxigain the US; Forxigain ROW

Q4 2019 New Molecular Entity (NME)1pipeline

Phase I

Phase II

18 New Molecular Entities

27 New Molecular Entities

Phase III

12 New Molecular Entities

Under Review

2 New Molecular Entities

AZD0466

BCL2/xL haematological and solid tumours

AZD1390 glioblastoma

AZD4573 CDK9 haematological malignancies

AZD5153

BRD4 solid tumours, haematological malignancies

AZD5991 MCL1 haematological malignancies

AZD9496

SERD ER+ breast

Calquence+ceralasertib (AZD6738) BTK+ATR haematological tumours

Calquence+danvatirsen BTK+STAT3 haematological malignancies

Imfinzi#+adavosertib#

PD-L1+Wee1 solid tumours

Imfinzi#+RT (platform) CLOVER PD-L1+RT HNSCC NSCLC SCLC

Imfinzi#+tremelimumab

adavosertib#

PD-L1+CTLA-4 solid tumours

Wee1 ovarian cancer, solid tumours

Imfinzi#+tremelimumab+chemo

AZD2811

PD-L1+CTLA-4 1L PDAC oesophageal

Aurora solid tumours, haematological

SCLC

malignancies

Imfinzi+selumetinib#

AZD4635

PD-L1+MEK solid tumours

A2aR inhibitor prostate cancer

MEDI1191

AZD9833

IL-12 mRNA solid tumours

SERD ER+ breast

MEDI2228

capivasertib#

BCMA ADC multiple myeloma

AKT breast

MEDI5083

capivasertib#

CD40 ligand fusion protein solid

AKT prostate

tumours

MEDI5395

Enhertu#

rNDV GMCSF solid tumours

ADC colorectal cancer

oleclumab+Tagrisso

Enhertu#

CD73+EGFR EGFRm NSCLC

ADC NSCLC

Imfinzi# (platform) COAST

PD-L1+multiple novel ONC therapies

NSCLC

Imfinzi# (platform) NeoCOAST

PD-L1++multiple novel ONC therapies

NSCLC

Imfinzi#+AZD4635

PD-L1+A2aR prostate cancer

Imfinzi#+AZD5069 or Imfinzi# + danvatirsen# PD-L1+(CXCR2 or STAT3) HNSCC bladder NSCLC

Imfinzi#+Lynparza# ORION

PD-L1+PARP 1L mNSCLC

Imfinzi#+monalizumab#

PD-L1+NKG2a solid tumours

Imfinzi#+oleclumab

PD-L1+CD73 solid tumours

Imfinzi#+tremelimumab PD-L1+CTLA-4 gastric cancer

Imfinzi#+tremelimumab PD-L1+CTLA-4 biliary tract oesophageal

Imfinzi+Lynparza# BAYOU

PD-L1+PARP bladder

Lynparza#+adavosertib#

PARP+Wee1 solid tumours

Lynparza#+AZD6738 VIOLETTE PARP+ATR breast

Lynparza#+Imfinzi MEDIOLA

PARP+PD-L1 ovarian breast gastric

SCLC

MEDI5752

PD-1/CTLA-4 solid tumours

oleclumab+AZD4635 CD73+A2aR prostate cancer

oleclumab+chemo or Imfinzi#+ oleclumab+chemo CD73+chemo or PD-L1+CD73+chemo pancreatic

Tagrissocombo# TATTON EGFR+PD-L1/MEK/MET NSCLC

Tagrisso+savolitinib# SAVANNAH EGFR+MET advanced EGFRm

NSCLC

capivasertib+chemotherapy CAPItello-290 AKT+chemotherapy mTNBC 1L

Enhertu# DESTINY-Breast 02 ADC breast

Enhertu# DESTINY-Breast 03 ADC breast

Enhertu# DESTINY-Breast 04 ADC breast

Enhertu¶# DESTINY-Gastric01 ADC gastric

Imfinzi#+/-tremelimumab+chemo

POSEIDON

PD-L1+/-CTLA-4+SoC 1L NSCLC

Imfinzi#+/-tremelimumab+CRT

ADRIATIC PD-L1+/-CTLA-4+CRTLS-SCLC

Imfinzi#+tremelimumab DANUBE PD-L1+CTLA-4 1L bladder

Imfinzi#+tremelimumab HIMALAYA PD-L1+CTLA-4 1L HCC

Imfinzi#+tremelimumab KESTREL PD-L1+CTLA-4 1L HNSCC

Imfinzi#+tremelimumab+SoC NILE PD-L1+CTLA-4+SoC 1L urothelial cancer

Lynparza#+Imfinzi#+bevacizumab

DUO-OPARP+PD-L1+VEGF 1L ovarian

Imfinzi#+/-tremelimumab+SoC

CASPIAN

PD-L1+/-CTLA-4+SoC 1L ES-SCLC

selumetinib#¶ SPRINT

MEK paediatric neurofibromatosis type-1

1includes novel combinations and additional indications for assets

3

where the lead is not yet launched

Imfinzi#+MEDI0457#

PD-L1+DNA HPV vaccine HNSCC

Oncology

Precision medicine approach under investigation

# Partnered and/or in collaboration; Registrational Phase II/III study

Q4 2019 New Molecular Entity (NME)1pipeline

Phase I

Phase II

16 New Molecular Entities

22 New Molecular Entities

Phase III

5 New Molecular Entities

Under Review

0 New Molecular Entities

AZD0284

AZD8233

abediterol#

RORg psoriasis / respiratory

hypercholesterolemia cardiovascular

LABA asthma / COPD

AZD4041#

AZD9977

anifrolumab#

orexin 1 receptor antagonist opinoid

MCR cardiovascular

Type I IFN receptor SLE SC

use disorder

AZD0449

MEDI0618

anifrolumab#

PAR2 antagonist mAb osteoarthritis

Inhaled JAK inhibitor asthma

Type I IFN receptor lupus nephritis

pain

AZD1402#

MEDI1341#

AZD4831

inhaled IL4Ra asthma

alpha synuclein parkinson's disease

MPO HFpEF

AZD2693

MEDI1814#

AZD5718

nonalcoholic steatohepatitis

amyloidβ alzheimer's disease

FLAP coronary artery disease

AZD5634

MEDI5117# China

AZD7594

inhaled ENaC cystic fibrosis

IL6 YTE rheumatoid arthritis

Inhaled SGRM asthma / COPD

AZD6615

MEDI6570

AZD7986#

hypercholesterolemia CV disease

LOX-1 CV disease

DPP1 COPD

AZD8154

MEDI7219

AZD8601#

Inhaled PI3Kgd asthma

anti-diabetictype-2 diabetes

VEGF-A cardiovascular

AZD8871#

MABA COPD

AZD9567

SGRM RA / respiratory

cotadutide

GLP-1/glucagontype-2 diabetes /

obesity / NASH

4

1includes novel combinations and additional indications for assets where the lead is not yet launched

# Partnered and/or in collaboration; Registrational Phase II/III study

MEDI3506

Diabetic kidney disease

MEDI3506

IL33 AD / COPD

MEDI3902

Psl/PcrV Pseudomonas pneumonia

MEDI5884# cholesterol modulation cardiovascular

MEDI6012

LCAT cardiovascular

MEDI7352

NGF/TNF OA pain / painful diabetic neuropathy

roxadustat#

HIF-PH inhibitor chemo induced anaemia

suvratoxumab α-Toxin Staphylococcus pneumonia

tezepelumab#

TSLP atopic dermatitis

tezepelumab#

TSLP COPD

verinurad

URAT-1 chronic kidney disease

BioPharmaceuticals

anifrolumab# TULIP Type I IFN receptor SLE

nirsevimab (MEDI8897)# RSV mAb-YTE passive RSV immunisation

PT027

ICS/SABA asthma

roxadustat#

HIFPH anaemia MDS

tezepelumab#

NAVIGATOR SOURCE

TSLP severe uncontrolled asthma

Precision medicine approach under investigation

Q4 2019 Lifecycle Management (LCM)1pipeline

Phase I

Phase II

1 Project

6 Projects

Phase III

20 Projects

Under Review

1 Project

Imfinzi#+azacitidine#

Imfinzi#

PD-L1+azacitidine MDS

PD-L1 solid tumours

Imfinzi# (platform) BEGONIA

PD-L1 1L mTNBC

Imfinzi# (platform) MAGELLAN

PD-L1 1L mNSCLC

Imfinzi+FOLFOX+bevacizumab (platform) COLUMBIA1 PD-L1+chemo+VEGF+multiple novel ONC therapies 1L MSS-CRC

Lynparza# (basket) MK-7339-002 /

LYNK002

PARP HRRm cancer

Lynparza#+cediranib CONCERTO

PARP+VEGF recurrent Pt-R ovarian

Calquence#

BTK inhibitor 1st line MCL

Calquence#

BTK inhibitor r/r CLL, high risk

Calquence# + venetoclax + obinutuzumab BTK+BCL-2+anti-CD20 1st line CLL

Imfinzi# CALLA

PD-L1 adj. locally advanced cervical cancer

Imfinzi# PEARL

PD-L1 1L metastatic NSCLC

Imfinzi# post-SBRTPACIFIC-4PD-L1post-SBRT stage I/II NSCLC

Imfinzi# POTOMAC PD-L1 non muscle invasive bladder cancer

Imfinzi#+CRT PACIFIC-2

PD-L1+CRT NSCLC

Imfinzi#+CRT PACIFIC-5 (China) PD-L1+CRTlocally-advanced stage III NSCLC

Imfinzi#+CTx neoadjuvant AEGEANPD-L1+CTxlocally-advanced stage I-III NSCLC

Imfinzi#+CTx NIAGARA PD-L1+CTx muscle invasive bladder cancer

Imfinzi#+CTx TOPAZ-1PD-L1+CTx 1L biliary tract cancer

Imfinzi#+VEGF EMERALD-2

PD-L1+VEGF adjuvant HCC

Imfinzi#+VEGF+TACE EMERALD-1PD-L1+VEGF+TACE locoregional

HCC

Lynparza# OlympiA

PARP gBRCA adjuvant breast

Lynparza# SOLO-3

PARP BRCAm PSR ovarian

Lynparza+abiraterone# PROpel PARP+NHA prostate cancer

Tagrisso ADAURA

EGFR adj. EGFRm NSCLC

Tagrisso LAURA

EGFRm locally advanced unresectable

NSCLC

Tagrisso+chemo FLAURA2 EGFR+chemo 1L adv EGFRm NSCLC

Lynparza# PROfound PARP prostate cancer

5

1Includes significant LCM projects and parallel indications for assets beyond Phase III

Oncology

Precision medicine approach under investigation

# Partnered and/or in collaboration; Registrational Phase II/III study

Q4 2019 Lifecycle Management (LCM)1pipeline

Phase

I

Phase II

Phase III

Under Review

0 Projects

1 Project

9 Projects

4 Projects

Breztri

Brilinta/Brilique HESTIA

Brilinta/Brilique THEMIS

LABA/LAMA/ICS asthma

P2Y12 paeds w/ sickle cell

P2Y12 diabetes & CAD outcomes

Brilinta/Brilique THALES

Farxiga/Forxiga DAPA-HF

P2Y12 stroke

SGLT2 HFrEF

Farxiga/Forxiga Dapa-CKD

Nexium(CN only)

SGLT2 CKD

stress ulcer prophylaxis

Farxiga/Forxiga DELIVER

Symbicort SYGMA

SGLT2 HFpEF

as needed in mild asthma

Farxiga/Forxiga DETERMINE-

Preserved

Farxiga/Forxiga DETERMINE-

Reduced

Fasenra MANDARA

IL5R EGPA

Fasenra# OSTRO, ORCHID

IL5R nasal polyposis

Fasenra# RESOLUTE

IL5R COPD

1Includes significant LCM projects and parallel indications for assets beyond Phase III

6

# Partnered and/or in collaboration; Registrational Phase II/III study

BioPharmaceuticals

Precision medicine approach under investigation

Estimated key regulatory submission acceptances

NME

LCM

PT027 asthma

tezepelumab asthma

NAVIGATOR

Enhertu

Enhertu

Fasenrasevere asthma (China)

gastric cancer (Japan)

DESTINY-Breast02

Imfinzi+ tremelimumab bladder

anifrolumab SLE

Imfinzi+ tremelimumab HCC

capivasertb + CTx 1L mTNBC

Imfinzi+ tremelimumab + CRT LDS-SCLC

DANUBE

TULIP

HIMALAYA

CAPItello-290

ADRIATIC

Imfinzi+ tremelimumab HNSCC

Enhertu

Imfinzi+/- tremelimumab NSCLC

Enhertu

Imfinzi+ tremelimumab+ SoC urothelial

KESTREL

DESTINY-Breast01 (EU)

POSEIDON

DESTINY-Breast03

NILE

selumetinib NF1

Imfinzi+/- tremelimumab SCLC

Lynparza+ cediranib ovarian

Enhertu

Lynparza+Imfinzi+ bevacizumab ovarian

SPRINT (EU)

CASPIAN (China)

GY004

DESTINY-Breast04

DUO-O

H1 2020

H2 2020

2021

2021+

Brilinta stroke

Lynparza ovarian

Brilintapaeds w/ sickle cell

Calquence 1L MCL

TagrissoEGFrm NSCLC

THALES

SOLO-3

HESTIA

ECHO

ADAURA

Symbicortmild astha (EU)

Fasenranasal polyposis

Calquencer/r CLL, high risk

Tagrissolocally adv. unresectable NSCLC

SYGMA

OSTRO

ELEVATE-RR

LAURA

Farxiga CKD

Calquence+venetoclax+obinutuzumab

Tagrisso +CTx EGFRm NSCLC

DAPA-CKD

1L CLL

FLAURA2

FarxigaHFrEF / HFpEF

Imfinzi cervical

Bydureon Bcisetype-2 diabetes (China)

DETERMINE

CALLA

Imfinziadjuvant NSCLC

Imfinzi +CTx biliary tract

DuaklirGenuair COPD (China)

BR.31

TOPAZ-1

Imfinzineoadjuvant NSCLC

Imfinzinon muscle invasive bladder

Farxiga HFpEF

AEGEAN

POTOMAC

DELIVER

Imfinzi NSCLC

Imfinzi+ chemo muscle invasive bladder

Fasenra COPD

PEARL

NIAGARA

RESOLUTE

Imfinzi+ CRT NSCLC

Imfinzipost-SBRT NSCLC

nirsevimab passive RSV immunisation

PACIFIC-2

PACIFIC-4

Imfinzi + VEGF + TACE locoregional HCC

Imfinzi+ CRT NSCLC

roxadustat anemia in MDS

EMERALD-1

PACIFIC-5 (China)

Lynparza breast

Imfinzi+ VEGF adjuvant HCC

Fasenranasal polyposis

OLYMPIA

EMERALD-2

ORCHID (China / Japan)

Lynparza+ abiraterone prostate

Fasenra EGPA

PROPEL

MANDARA

7

Note. NME section includes novel combinations and additional indications for assets where the lead is not yet launched

Oncology

BioPharmaceuticals

Designations

4

Accelerated approvals

Lynparzaovarian cancer SOLO-2 (US)

TagrissoEGFRm T790M NSCLC (US)

Imfinzibladder cancer (US)

Calquence MCL (US)

13

11

Breakthrough / PRIME1/ Sakigake2

Fast Track

TagrissoEGFRm T790M NSCLC (US)

MEDI3902 Psl-PcrV pneumo Px (US)

Lynparzaprostate cancer PROFOUND (US)

savratoxumab Staph HAP (US)

Imfinzibladder cancer 1L (US)

ImfinziNSCLC (US)

Calquence MCL (US)

nirsevimab (MEDI8897) RSV mAB (US)

Imfinzistage III NSCLC 1L PACIFIC (US)

ImfinziHNSCC HAWK (US)

TagrissoNSCLC 1L FLAURA (US)

anifrolumab SLE (US)

tezepelumab asthma (US)

Lynparzaovarian cancer SOLO-2 (US)

nirsevimab (MEDI8897) RSV mAB (US)

TagrissoEGFRm T790M NSCLC (CN)

nirsevimab (MEDI8897) RSV mAB (EU)1

FarxigaHFrEF (US)

selumetinib NFI type 1 SPRINT (US)

Farxigachronic kidney disease (US)

EnhertuDESINTY-BREAST01 (US)

cotadutide non-alcoholic steatohepatitis (US)

Calquence CLL (US)

Enhertugastric cancer (JP)2

29

Priority Review / RTOR3

TagrissoEGFRm T790M NSCLC (JP) TagrissoEGFRm T790M NSCLC (US) Imfinzibladder cancer 2L (US)

TagrissoNSCLC AURA3 (US)

Calquence MCL (US)

Lynparzabreast cancer OLYMPIAD (US) roxadustat CKD (CN)

TagrissoNSCLC FLAURA (US) Imfinzistage III NSCLC PACIFIC (EU) Imfinzistage III NSCLC PACIFIC (JP) Lynparzatablet (US)

Lynparzatablet (CN)

Lynparzabreast cancer OLYMPIAD (JP) TagrissoNSCLC 1L FLAURA (JP) LumoxitiHCL PLAIT (US)

Lynparzaovarian SOLO-1 (US)

Lynparzaovarian SOLO-1 (CN)

26

Orphan Drug

Lynparzaovarian cancer SOLO-2 (US) LumoxitiHCL PLAIT (US)

LumoxitiHCL PLAIT (EU) Crestorpaediatric (US) cediranib VEGFR tki (US) IressaEGFRm NSCLC (US)

TagrissoEGFRm T790M NSCLC (US)

AZD3241 MPO (EU)

CalquenceCLL 1L (US)

Calquence MCL (US)

Calquence WM (US)

Calquence WM (EU)

CalquenceCLL 1L (EU)

Calquence MCL (EU)

selumetinib thyroid cancer ASTRA (US) Lynparzabreast cancer OLYMPIAD (JP) Lynparzaovarian cancer SOLO-2 (JP)

FAST TRACK is a process designed to facilitate the development, and expedite the review of medicines to treat serious conditions and fill an unmet medical need. 3REAL-TIME ONCOLOGY REVIEW (RTOR) and Project Orbis is an initiative of the FDA Oncology Centre of Excellence (OCE) providing a framework for concurrent submission and review of oncology products among international partners.

BREAKTHROUGH DESIGNATION is a process designed to expedite the development and review of medicines which may demonstrate substantial improvement over available therapy. 1PRIME is a scheme launched by the EMA to enhance support for the development of medicines that target an unmet medical need. 2SAKIGAKE is aimed at early introduction of innovative medicines, medical devices, etc. that are initially developed in Japan

ACCELERATED APPROVAL, these regulations allowed medicines for serious conditions that addressed an unmet medical need to be approved based on a surrogate endpoint.

PRIORITY REVIEW DESIGNATION is the US FDA's goal to take action on an application within 6 months.

ORPHAN DRUG DESIGNATION, intended for treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 patients in the US, or that affect more than 200,000 patients but are not expected to recover the costs of developing and marketing a treatment drug.

Breztri Aerosphere (PT010) COPD (CN) TagrissoNSCLC 1L FLAURA (CN)Breztri Aerosphere(PT010) (CN) Lokelmahyperkalaemia (CN) Lynparzapancreatic 1L (US)

EnhertuDESINTY-BREAST01 (US)

FarxigaHF (DAPA-HF) (US)

Imfinzi+/-treme+SOC SCLC 1L (CASPIAN) (US) Lynparzaprostate (PROfound) (US)

Lynparza+Avastin ovarian 1L (PAOLA-1) (US) selumetinib NFI type 1 SPRINT (US) CalquenceCLL (ELEVANTE-TN, ASCEND)3

selumetinib NFI type 1 SPRINT (US) selumetinib NFI type 1 SPRINT (EU) Lynparzapancreatic cancer POLO (US) FasenraEGPA (US)

FasenraHES (US) saracatinib IPF (US)

Imfinzi+/-treme+SOC SCLC 1L CASPIAN (US) FasenraEoE (US)

Imfinzi+treme HCC 1L (HIMALAYA)

8

Oncology

BioPharmaceuticals

Oncology - approved medicines and late-stage pipeline

Approved medicines

Tagrisso

(highly-selective, irreversible EGFRi)

Late-stage development

Early development

NSCLC

Trial

Population

Patients

Design

Endpoints

Status

Phase III

Adjuvant EGFRm NSCLC

682

Arm 1: TagrissoQD following complete tumour resection, with

Primary endpoint: DFS

FPCD: Q4 2015

ADAURA

or without chemo

Secondary endpoints: DFS Rate, OS, OS

LPCD: Q1 2019

NCT02511106

Arm 2: placebo

Rate, QoL

Data anticipated: 2022

Global trial - 25 countries

Phase III

Maintenance therapy in

200

Arm 1:Tagrisso

Primary endpoint: PFS (BICR)

FPCD: Q3 2018

LAURA

patients with

Arm 2: placebo

Secondary endpoints: CNS PFS, OS,

Data anticipated: 2021+

NCT03521154

locally advanced,

Global trial - 11 countries

DoR, ORR, DCR

unresectable EGFRm Stage

III NSCLC whose disease has

not progressed following

platinum-based

chemoradiation therapy

Phase III

Real world setting in adult

3,020

Single-arm trial - Tagrisso

Primary endpoints: OS and safety

FPCD: Q3 2015

ASTRIS

patients with advanced or

Secondary endpoint: PFS

LPCD: Q4 2017

metastatic, EGFRm T790M+

Global trial - 16 countries

NCT02474355

NSCLC

Phase II

EGFR TKI treatment-naïve

150

Single arm trial - Tagrisso

Primary Endpoint: proportion of patients

FPCD: Q2 2018

ELIOS

patients with locally-advanced

with a given tumour genetic and

or metastatic EGFRm NSCLC

Global trial - five countries

proteomic marker at the point of disease

NCT03239340

progression as defined by the

investigator

Secondary endpoint: PFS, ORR, DoR

Phase I

Patients with EGFRm NSCLC

8

Single-arm trial - Tagrisso

Primary Endpoints: assessments of brain

FPCD: Q4 2018

ODIN-BM

with brain metastases

standard uptake value (SUV) and

pharmacokinetics (PK)

NCT03463525

Secondary endpoints: PK

Oncology

CVRM

Respiratory

Other

10

Approved medicines

Tagrisso(highly-selective, irreversible EGFRi)

Late-stage development

Early development

NSCLC, combinations

Trial

Population

Patients

Design

Endpoints

Status

Phase III

1st-line EGFRm NSCLC

586

Arm 1: Tagrissoplus Pemetrexed/Carboplatin or

Primary endpoint: PFS

FPCD: Q4 2019

FLAURA2

Pemetrexed/Cisplatin

Secondary endpoints: OS, LOS, ORR

Data anticipated: 2021+

NCT04035486

Arm 2:Tagrisso

DoR, Depth of response, PFS2. QoL, PK

Global trial - 5+ countries

Phase II

Advanced EGFRm NSCLC

150

Modular design platform study:

Primary endpoint: ORR

FPCD: Q3 2019

ORCHARD

patients who have progressed

Module 1: Tagrisso+ savolitinib

Secondary endpoints: PFS, DoR, OS,

Data anticipated: 2021+

on first line Tagrissotreatment

Module 2: Tagrisso+ gefitinib

safety and tolerability

NCT03944772

Module 3: Tagrisso+ necitumumab

Module 4:carboplatin + pemetrexed + Imfinzi

No intervention: observational cohort - no study drug

Global trial - 8 countries

Phase II

EGFRm / MET+, locally

172

Single arm trial: Tagrisso+ savolitinib

Primary endpoint: ORR

FPCD Q1 2019

SAVANNAH

advanced or metastatic

Secondary endpoints include PFS, DoR

Data anticipated: 2021+

NSCLC who have progressed

Global trial

and OS

NCT03778229

following treatment with

Tagrisso

Phase Ib

Advanced EGFRm NSCLC

344

Arm 1:Tagrisso +Imfinzi

Safety, tolerability, pharmacokinetics and

FPCD: Q3 2014

TATTON

TKI failure

Arm 2: Tagrisso+ savolitinib

preliminary anti-tumour activity

Data anticipated: 2020

Arm 3: Tagrisso+ selumetinib

NCT02143466

Enrolment to Imfinzicombination arms will not restart

Global trial

Oncology

CVRM

Respiratory

Other

11

Approved medicines

Imfinzi(PD-L1 mAb)

Late-stage development

Early development

NSCLC, early disease

Trial

Population

Patients

Design

Endpoints

Status

Phase III

Neoadjuvant NSCLC patients

800 / 300

Arm 1: Imfinzi+ platinum-based chemo

Primary endpoint:

FPCD: Q1 2019

Stage II and III resected

Arm 2: placebo + platinum-based chemo

mPR

Data anticipated: H2 2020

AEGEAN

NSCLC

Secondary endpoint

NCT03800134

(incl. EGFR/ALK positive)

pCR

Phase III

Adjuvant NSCLC patients

1,360

Arm 1: Imfinzimg/kg i.v. Q4W x 12m

Primary endpoint:

FPCD: Q1 2015

ADJUVANT BR.31

Ib (≥4cm) - stage IIIa resected

Arm 2: placebo

DFS

Data anticipated: 2021

NSCLC

NCT02273375

(incl. EGFR/ALK positive)

Global trial

Secondary endpoint:

Partnered

OS

Phase III

Unresected, locally-advanced

300

Arm 1: Imfinzii.v. Q4W + chemo/RT

Primary endpoint:

FPCD: Q2 2018

NSCLC

Arm 2: placebo + chemo/RT

PFS

LPCD: Q3 2019

PACIFIC-2

ORR

Data anticipated: H2 2020

ex US global trial

Secondary endpoint:

NCT03519971

OS

Phase III

Imfinzifollowing SBRT in

630

Arm 1: Imfinzii.v. Q4W following definitive SBRT

Primary endpoint:

•FPCD: Q2 2019

unresected, Stage I/II NSCLC

Arm 2: placebo following definitive SBRT

PFS

•Data anticipated: 2021+

PACIFIC-4

Secondary endpoint:

OS

NCT03833154

Phase III

Unresected, locally-advanced

360

Arm 1: Imfinzii.v. Q4W following chemo/RT

Primary endpoint:

FPCD: Q1 2019

NSCLC

Arm 2: placebo following chemo/RT

PFS

Data anticipated: 2021+

PACIFIC-5

Secondary endpoint:

NCT03706690

ex US global trial, China focus

OS

Phase II/III Lung Master

Stage IV squamous NSCLC

140

Umbrella trial with five arms based on biomarker expression:

Primary endpoints:

• FPCD: Q2 2014

Protocol

patients

Substudy A: Imfinzi(non-match for other biomarker driven

• ORR

• Data anticipated: 2021+

substudies) i.v. Q2W single arm ImfinziPhase II only

• PFS

NCT02154490

Biomarker-targeted

Substudy B: PI3K inhibitor vs. docetaxel

• OS

Partnered

2L therapy

Substudy C: CDK4/6 inhibitor vs, docetaxel

Substudy D: AZD4547 (FGFR inhibitor) vs. docetaxel

Substudy E: C-MET/HGFR Inhibitor + erlotinib vs. erlotinib

Oncology

CVRM

Respiratory

Other

12

Approved medicines

Imfinzi(PD-L1 mAb) +/- treme (CTLA-4 mAb)

Late-stage development

Early development

Lung cancer, advanced disease

Trial

Population

Patients

Design

Endpoints

Status

Phase III

NSCLC 1L

650

Arm 1: ImfinziQ4W

Primary endpoint:

FPCD: Q1 2017

PEARL

Arm 2: chemotherapy

OS

LPCD: Q1 2019

NCT03003962

Asia trial

Data anticipated: 2021

Phase III

NSCLC 1L

1,000

Arm 1: Imfinzi+ chemo

Primary endpoint:

FPCD: Q2 2017

POSEIDON

Arm 2: Imfinzi+ tremelimumab + chemo

OS

LPCD: Q4 2018

Arm 3: SoC

PFS

Data readout: Q4 2019

NCT03164616

PFS primary endpoint met

OS Data anticipated: 2021

Phase II

NSCLC 1L

200

Arm A1: Imfinzi

Primary endpoint:

FPCD: Q1 2019

MAGELLAN

Arm A2: Imfinzi+ danvatirsen

Safety & tolerability

Data anticipated: H2 2020

Arm A3: Imfinzi+ oleclumab

Secondary endpoint:

NCT03819465

Arm B1: Imfinzi+ Investigator's choice of chemo

• ORR, DoR, PFS, OS, PK, ADA

• Arm B2: Imfinzi+ danvatirsen + Investigator's choice of chemo

• Arm B3: Imfinzi+ oleclumab + Investigator's choice of chemo

Phase III

Limited disease- SCLC 1L

600

Arm 1: Imfinzi+ tremelimumab (4 doses)

Primary endpoints:

FPCD: Q4 2018

ADRIATIC

following platinum-based

Arm 2: Imfinzi

PFS

Data anticipated: 2021

concurrent chemoradiation

Arm 3: placebo

OS

NCT03703297

therapy

Phase III

SCLC 1L

795

Arm 1: Imfinzi+ tremelimumab + EP (carboplatin or cisplatin +

Primary endpoint:

FPCD: Q1 2017

CASPIAN

etoposide)

OS

LPCD: Q2 2018

Arm 2: Imfinzi+ EP (carboplatin or cisplatin + etoposide)

Data readout: Q2 2019

NCT03043872

Arm 3: EP (carboplatin or cisplatin + etoposide)

OS Primary endpoint met for Imfinzi

monotherapy arm

Phase II

SCLC

80

Arm A: Imfinzi+ tremelimumab Q4W

Primary endpoint: ORR

FPCD: Q4 2016

BALTIC

Arm B: adavosertib and carboplatin BID

Data anticipated: 2021

NCT02937818

Arm C: AZD6738 and Lynparza

Oncology

CVRM

Respiratory

Other

13

Approved medicines

Imfinzi(PD-L1 mAb)

Late-stage development

Early development

Other cancers, early disease

Trial

Population

Patients

Design

Endpoints

Status

Phase III

Non-muscle invasive bladder

975

Arm 1: BCG (Induction + maintenance)

Primary endpoints:

FPCD: Q4 2018

POTOMAC

cancer

Arm 2: Imfinzi+ BCG (Induction only)

DFS

Data anticipated: 2021+

NCT03528694

Arm 3: Imfinzi+ BCG (Induction + maintenance)

Phase III

Muscle-invasive bladder

960

Arm 1: Imfinziin combination with gemcitabine + cisplatin,

Coprimary endpoints:

FPCD: Q4 2018

NIAGARA

cancer

Imfinzimaintenance

pCR

Data anticipated: 2021+

NCT03732677

Arm 2: gemcitabine + cisplatin

EFS

Phase III

Locoregional HCC

600

Arm A: TACE in combination with Imfinzi

Primary endpoint

FPCD: Q1 2019

EMERALD-1

Arm B: TACE in combination with Imfinzi+ bevacizumab

PFS for Arm A vs Arm C

Data anticipated: 2021

NCT03778957

Arm C: TACE in combination with placebo

Secondary endpoint

PFS for Arm B vs Arm C , OS

Phase III

Adjuvant therapy in HCC

888

Arm 1: Imfinzi+ bevacizumab

Primary endpoint:

FPCD: Q2 2019

EMERALD-2

Arm 2: Imfinzi+ placebo

• RFS for Arm 2 vs Arm 3

Data anticipated: 2021+

NCT03847428

• Arm 3: placebo + placebo

Secondary endpoint:

RFS Arm 1 vs Arm 3, OS, RFS at 24

mos

pCR = Pathologic Complete Response EFS = event free survival

Oncology

CVRM

Respiratory

Other

14

Approved medicines

Imfinzi(PD-L1 mAb) +/- treme (CTLA-4 mAb)

Late-stage development

Early development

Other cancers, advanced disease

Trial

Population

Patients

Design

Endpoints

Status

Phase III

Cis-eligible and ineligible

1,005

Arm 1: Imfinzi+ tremelimumab

Primary endpoints:

FPCD: Q4 2015

DANUBE

bladder cancer 1L

Arm 2: Imfinzi

OS

LPCD: Q1 2017

NCT02516241

Arm 3: SoC

Data anticipated: H1 2020

Phase III

Bladder cancer 1L

885

Arm 1: Imfinzi+ tremelimumab + SoC

Primary endpoints:

FPCD: Q4 2018

NILE

Arm 2: Imfinzi+ SoC

PFS

Data anticipated: 2021

NCT03682068

Arm 3: SoC

OS

Phase III

HNSCC 1L

823

Arm 1: Imfinzi

Primary endpoints:

FPCD: Q4 2015

KESTREL

Arm 2: Imfinzi+ tremelimumab

OS

LPCD Q1 2017

NCT02551159

Arm 3: SoC

Data anticipated: H1 2020

Phase III

HCC 1L

1,310

Arm 1: Imfinzi+ tremelimumab

Primary endpoint:

FPCD: Q4 2017

HIMALAYA

Arm 2: Imfinzi

OS

LPCD: Q4 2019

Arm 3: sorafenib

Secondary endpoint:

Data anticipated: H2 2020

NCT03298451

PFS, TTP, ORR

Phase II

Urothelial bladder cancer

76

Arm 1 tremelimumab (urothelial bladder cancer)

Primary endpoint:

FPCD: Q4 2015

triple-negative breast cancer

Arm 2 tremelimumab (triple-negative breast cancer)

ORR

Data readout: Q4 2018

pancreatic ductal-

Arm 3 tremelimumab (pancreatic ductal-adenocarcinoma)

NCT02527434

adenocarcinoma

Secondary endpoints:

Safety, DoR

Phase III

BTC 1L

474

Treatment Arm 1 Imfinzi+ gemcitabine + cisplatin

Primary endpoint:

FPCD Q2 2019

TOPAZ-1

Treatment Arm 2 placebo + gemcitabine + cisplatin

OS

Data anticipated: 2021+

NCT03875235

Global trial

Secondary endpoint:

PFS, ORR, DoR

Phase III

Locally advanced cervical

714

Arm 1 Imfinzi+ EBRT + brachytherapy with platinum

Primary

FPCD: Q1 2019

CALLA

cancer

Arm 2 placebo + EBRT + brachytherapy with platinum

PFS

Data anticipated: 2021+

Secondary

NCT03830866

Global trial

OS, CR rate, DoR, ORR,

safety/tolerability

Oncology

CVRM

Respiratory

Other

15

Approved medicines

Imfinzi(PD-L1 mAb) +/- treme (CTLA-4 mAb)

Late-stage development

Early development

Other cancers

Trial

Population

Patients

Design

Endpoints

Status

Phase III

Advanced solid malignancies

1,200

Arm 1: Imfinzi

Primary endpoint: Safety

FPCD: Q2 2017

STRONG

Arm 2: Imfinzi+ tremelimumab

Data anticipated: 2021+

NCT03084471

Phase I Combination in

Solid tumours

80

Arm 2 SCLC: Imfinzi+ tremelimumab + carboplatin + etoposide

Safety

FPCD: Q1 2016

Advanced Solid Tumours

Arm 3 TNBC: Imfinzi+ tremelimumab + chemo

LPCD: Q1 2019

Arm 4 TNBC: Imfinzi+ tremelimumab + chemo

Data anticipated: 2021+

NCT02658214

Arm 5 GEJ: Imfinzi+ tremelimumab + oxaliplatin + 5-FU +

leucovorin

Arm 6 PDAC: Imfinzi+ tremelimumab + chemo

Arm 7 ESSC: Imfinzi+ tremelimumab + chemo

Phase I Immunotherapy in

HNSCC, NSCLC, SCLC

300

HNSCC Arm 1

Safety

FPCD: Q2 2018

Combination With

NSCLC Arm 1

Data anticipated: 2021+

Chemoradiation in Patients

NSCLC Arm 2

With Advanced Solid

NSCLC Arm 3

Tumours

SCLC Arm 2

SCLC Arm 3

CLOVER

SCLC Arm 4

NCT03509012

Phase II

mTNBC 1L

110

Arm 1 Imfinzi+ paclitaxel

Primary endpoint:

FPCD: Q1 2019

BEGONIA

Arm 2 Imfinzi+ paclitaxel + capivasertib

Safety and tolerability

Data anticipated: H2 2020

• Arm 4 Imfinzi+ paclitaxel + danvatirsen

NCT03742102

Arm 5 Imfinzi+ paclitaxel + oleclumab

Secondary endpoint:

Global trial

• ORR, PFS, DoR, OS, PK, ADA

Oncology

CVRM

Respiratory

Other

16

Approved medicines

Lynparza(PARP inhibitor)

Late-stage development

Early development

Ovarian and other cancers

Trial

Population

Patients

Design

Endpoints

Status

Phase III

BRCAm adjuvant breast

1,836

Arm 1: LynparzaBiD 12 month duration

Primary endpoint: invasive disease-free

FPCD: Q2 2014

OlympiA

cancer

Arm 2: placebo 12-month duration

survival (IDFS)

LPCD: Q2 2019

Secondary endpoint: distant disease-free

Data anticipated: 2021

NCT02032823

Global trial partnership with BIG and NCI/NRG

survival and OS

Partnered

Phase III

gBRCAm pancreatic cancer

154

Arm 1: Lynparzatablets 300mg twice daily as maintenance

Primary endpoint: PFS

FPCD: Q1 2015

POLO

therapy until progression

Secondary endpoint: OS

LPCD: Q1 2019

Arm 2: placebo tablets BID

Data readout: Q1 2019

NCT02184195

Global trial

Primary endpoint met

Phase III

Metastatic castration-resistant

387

Arm 1: LynparzaBID

Primary endpoint: radiologic PFS

FPCD: Q2 2017

PROfound

prostate cancer

Arm 2: physician's choice:

Secondary endpoints: ORR, Time to Pain

LPCD: Q4 2018

HRRm, 2L+

enzalutamide 160mg once daily or abiraterone acetate

Progression, OS

Data readout : Q3 2019

NCT02987543

1,000mg once daily

Primary endpoint met

Global trial

Oncology

CVRM

Respiratory

Other

17

Approved medicines

Lynparza(PARP inhibitor)

Late-stage development

Early development

Imfinzicombinations

Trial

Population

Patients

Design

Endpoints

Status

Phase III

Advanced ovarian cancer 1L

1,056

Non tBRCAm (tumour BRCA) patients

Primary endpoint:

FPCD: Q1 2019

DuO-O

Arm 1: bevacizumab

PFS

Data anticipated: 2021+

• Arm 2: bevacizumab + Imfinzi

NCT03737643

Arm 3:bevacizumab + Imfinzi+ Lynparza

Secondary endpoints:

tBRCAm patients

OS, PFS2

bevacizumab (optional) + Imfinzi+ Lynparza

Global trial

Phase II

Stage IV NSCLC whose disease has

250

Arm 1:Imfinzi +Lynparza

Primary endpoint:

FPCD Q1 2019

ORION

not progressed following SoC chemo

Arm 2: Imfinzi+ placebo

PFS

Data anticipated: 2021+

NCT03775486

+ ImfinziMaintenance therapy 1L

Global trial

Secondary enpoints:

OS, ORR, DoR, PFS in HRRm, PK, ADA

Phase II

Platinum-Ineligible unresectable

154

Arm 1:Imfinzi +Lynparza

Primary endpoint: PFS

FPCD: Q1 2018

BAYOU

Stage IV urothelial cancer

Arm 2: Imfinzi+ placebo

Secondary endpoints: OS, DoR, ORR,

Data anticipated : H1 2020

NCT03459846

Global trial

PFS in HRRm, PFS6, PK, ADA, PRO

Phase I / II

gBRCAm ovarian cancer 2L+

148

Arm 1:Lynparza +Imfinzi

Primary endpoints:

FPCD: Q2 2016

MEDIOLA

gBRCAm HER2-negative breast

Dose until progression

DCR at 12 weeks

LPCD: Q2 2017

NCT02734004

cancer 1-3L

Global trial

Safety and tolerability

SCLC 2L+

Gastric cancer 2L+

Phase I / II

gBRCAm ovarian cancer 2L+

140

Arm 1:Lynparza +Imfinzi

Primary endpoints:

FPCD: Q2 2018

MEDIOLA

Non-gBRCAm ovarian cancer 2L+

Arm 2:Lynparza +Imfinzi

DCR at 12 weeks

(Ovarian expansion)

Non-gBRCAm ovarian cancer 2L+

Arm 3: Lynparza+ Imfinzi+ bevacizumab

ORR

NCT02734004

Dose until progression

Safety and tolerability

Global trial

Oncology

CVRM

Respiratory

Other

18

Approved medicines

Lynparza(PARP inhibitor)

Late-stage development

Early development

Other combinations

Trial

Population

Patients

Design

Endpoints

Status

Phase III

Advanced ovarian cancer 1L

806

Arm 1: Lynparzamaintenance therapy for two years or until

Primary endpoint:

FPCD: Q2 2015

PAOLA-1

maintenance

disease progression

PFS

LPCD: Q2 2018

Arm 2: placebo for two years or until disease progression

Data readout: Q3 2019

NCT02477644

Secondary endpoints:

Primary endpoint met

Externally sponsored

Global trial

OS, PFS2

Phase III

Metastatic castration-resistant

720

Arm 1: Lynparza+ abiraterone

Primary Endpoint:

FPCD: Q4 2018

PROpel

prostate cancer 1L

• Arm 2: placebo + abiraterone

rPFS

Data anticipated: 2021

NCT03732820

Global trial

Secondary endpoints:

TFST, TTPP, OS

Phase II

TNBC

450

• Arm 1: AZD6738 + Lynparza

PFS

FPCD: Q2 2018

Arm 2:Lynparza

ORR / OS

Data anticipated: 2021

VIOLETTE

Trial conducted in 15 countries: North America, Europe and Asia

Safety and tolerability

NCT03330847

Phase III

Recurrent platinum sensitive

549

Arm 1: chemo

Primary endpoint:

FPCD: Q1 2016

GY004

ovarian cancer

Arm 2:Lynparza

PFS

Data anticipated: H1 2020

• Arm 3: cediranib + Lynparza

NCT02446600

Secondary endpoints:

Externally sponsored

US/Canada/Japan sites​

OS, QoL, safety​

Phase II/III

Recurrent platinum

680

Arm 1: chemo

Primary endpoints:

FPCD: Q2 2016

GY005

resistant/refractory ovarian

• Arm 2: cediranib + Lynparza

PFS, OS

Data anticipated: 2021+

cancer

Arm 3: cediranib

NCT02502266

Arm 4:Lynparza

Secondary endpoints:

Externally sponsored

ORR, QoL, safety

US/Canada sites

Phase II

HRRm or HRD-positive

370

Arm 1:Lynparza

Primary endpoints:

FPCD: Q1 2019

LYNK-002

advanced cancer

ORR

Trial conducted in 15 countries worldwide

NCT03742895

Secondary endpoints:

Partnered

• DOR, OS, PFS, AE, Prog by CA-125

Oncology

CVRM

Respiratory

Other

19

Approved medicines

Calquence(BTK inhibitor)

Late-stage development

Early development

Blood cancers

Trial

Population

Patients

Design

Endpoint(s)

Status

Phase III

Previously untreated CLL

535

Arm A: chlorambucil + obinutuzumab

Primary endpoint: PFS (Arm A vs. Arm B)

FPCD: Q2 2015

ACE-CL-007(ELEVATE-TN)

Arm B: Calquence+ obinutuzumab

Secondary endpoints: IRC (independent

Data readout: Q2 2019

Arm C:Calquence

review committee) assessed ORR, OS

Primary endpoint met

NCT02475681

(Arm A vs. Arm B vs. Arm C)

Phase III

Previously untreated CLL

780

Arm A; Calquence+ venetoclax

Primary - IRC assessed PFS (arm A vs

FPCD: Q1 2019

fit

Arm B: Calquence+ venetoclax + obinutuzumab

arm C)

Data anticipated: 2021+

ACE-CL-311

Arm C: FCR or BR

Secondary - IRC assessed PFS (arm B

NCT03836261

vs arm C); INV assessed PFS (arm A vs

arm C; arm B vs arm C)

Phase III

Relapsed/refractory CLL

306

Arm A:Calquence

Primary endpoint: IRC assessed PFS

FPCD Q3 2016

ACE-CL-309 (ASCEND)

Arm B: rituximab + idelalisib or bendamustine (investigator's

(arm A vs. Arm B)

Data readout: Q2 2019

NCT02970318

choice)

Secondary endpoints: INV-assessed

Primary endpoint met

ORR, OS, DoR, PROs

Phase III

Relapsed/refractory high risk

533

Arm A:Calquence

Primary endpoint: PFS

FPCD: Q2 2015

ACE-CL-006(ELEVATE-RR)

CLL

Arm B: ibrutinib

Secondary endpoints: comparison of

Data anticipated: 2021+

incidence of infections, RTs (Richter's

NCT02477696

Transformation) and atrial fibrillation, OS

Phase III

Previously untreated MCL

546

Arm A: Calquence+ bendamustine + rituximab

Primary endpoint: PFS by Lugano

FPCD: Q1 2017

ACE-LY-308

Arm B: bendamustine + rituximab

Classification for NHL

Data anticipated: 2021+

Secondary endpoints: IA, PFS, ORR;

NCT02972840

IRC-assessed ORR, DoR, time to

response, OS

ORR at 36 cycles

FPCD: Q1 2016

Phase II

Relapsed/ refractory CLL,

60

Calquencemonotherapy

ACE-CL-208

intolerant to ibrutinib

Data anticipated: H1 2020

NCT02717611

Phase II

Relapsed/refractory and

48

Calquencemonotherapy

ORR

FPCD: Q4 2014

15-H-0016

treatment naïve/del17p

Arm A: lymph node biopsy

Data anticipated: 2021+

NCT02337829

CLL/SLL

Arm B: bone marrow biopsy

Phase I/II

CLL/SLL/Richter's

306

Calquencemonotherapy

Safety, PK, PD

FPCD: Q1 2014

ACE-CL-001

transformation

Dose escalation and expansion

Data anticipated: 2021

20NCT02029443

Oncology

CVRM

Respiratory

Other

Approved medicines

Calquence(BTK inhibitor)

Late-stage development

Early development

Blood cancers

Trial

Population

Patients

Design

Endpoint(s)

Status

Phase I/II

B-cell malignancies

40

Dose escalation and expansion trial of the combination of

Safety

FPCD: Q1 2015

ACE-LY-001

Calquenceand ACP-319 (Pi3K inhibitor)

ORR

Data anticipated: H1 2020

NCT02328014

Phase I/II

Haematological malignancies

161

Calquence+ pembrolizumab

Safety

FPCD: Q1 2015

ACE-LY-005

Secondary endpoints: ORR, DoR, PFS,

Data anticipated: 2021

OS, TTNT (time to next therapy)

NCT02362035

Phase I/II

Waldenstrom

106

Calquencemonotherapy

ORR

FPCD: Q3 2014

ACE-WM-001

microglobulinaemia

Data readout: Q4 2019

NCT02180724

Phase Ib

Relapsed/refractory de novo

21

Calquencemonotherapy

Safety

FPCD: Q3 2014

ACE-LY-002

activated B-cell DLBCL

Data anticipated: H2 2019

NCT02112526

Phase Ib

MCL

70

Calquencein combination with bendamustine and rituxumab

Safety

FPCD: Q1 2016

ACE-LY-106

Arm A: treatment naive

Data anticipated: 2021+

Arm B: relapsed/refractory

NCT02717624

Arm C: treatment naïve: Calquence+ venetoclax + rituxumab

Phase Ib

Relapsed/refractory MM

28

Arm A:Calquence

Safety

FPCD: Q1 2015

ACE-MY-001

Arm B: Calquence+ dexamethasone

Data readout: Q2 2019

NCT02211014

Phase I

Relapsed/refractory follicular

80

Arm A:Calquence

Safety

FPCD: Q1 2015

ACE-LY-003

lymphoma

Arm B: Calquence+ rituximab

Data anticipated: 2021+

NCT02180711

Arm C: Calquence+ rituximab + lenolidomide

Phase I

Relapsed/refractory CLL/ SLL

12

Calquencein combination with ACP-319

Safety, PK, PD

FPCD: Q3 2014

ACE-CL-002

dose escalation

Data anticipated: H2 2020

NCT02157324

Phase I

CLL/SLL/PLL

69

Calquence+ obinutuzumab

Safety, ORR

FPCD: Q4 2014

ACE-CL-003

Arm A: relapsed/refractory

Secondary endpoints: PD, PFS, TTNT,

Data anticipated: 2021+

NCT02296918

Arm B: treatment naïve

OS

Calquence +venetoclax + rituxumab

Arm C: relapsed/refractory

21

Arm D: treatment naïve

Oncology

CVRM

Respiratory

Other

Approved medicines

Calquence(BTK inhibitor)

Late-stage development

Early development

Blood cancers

Trial

Population

Patients

Design

Endpoint(s)

Status

Phase I

Japanese adults with

34

Calquencemonotherapy

Safety

FPCD: Q2 2017

advanced B-cell malignancies

Dose confirmation and expansion

PK

Data anticipated: 2021+

NCT03198650

Calquence+ obinutuzumab

Phase I/II

CLL r/r

62

Arm A:ceralasertib (AZD6738) monotherapy

Identify dose of ceralasertib and safety

FPCD: Q1 2018

CL-110

Arm B: Calquence+ ceralasertib (AZD6738)

of co-administration of Calquence+

Data anticipated: H1 2020

ceralasertib

NCT03328273

Phase I/II

B-cell malignancies r/r

25

Part 1: Calquencedaily + vistusertib daily

MTD and optimal dosing schedule

FPCD: Q3 2017

LY-110

Part 2: Calquencedaily + vistusertib 5 days on/2 days off

Safety

Data anticipated: H2 2020

NCT03205046

Phase III

CLL TN and r/r

600

Arm A: treatment naïve

Safety

Data anticipated: 2021+

CL-312

Arm B: relapsed/refractory

Arm C: prior BTKi therapy

NCT04008706

Arm D: concomitant vitamin K antagonists

Phase Ib/II

Relapsed/refractory

88

Arm 1: Calquence+ danvatirsen

Primary outcome; safety & tolerability

FPCD: Q2 2018

PRISM

aggressive NHL

Arm 2: Calquence+ AZD6738

Secondary outcomes; ORR, DOR, PFS,

Data anticipated: 2021

Arm 3: Calquence+ Hu5F9G4 + Rituxan

OS

NCT03527147

Arm 4: Calquence+ AZD5153

An open-label platform study with trial centres in US and UK

Oncology

CVRM

Respiratory

Other

22

Approved medicines

Calquence(BTK inhibitor)

Late-stage development

Early development

Other cancers

Trial

Population

Patients

Design

Endpoint(s)

Status

Phase Ib/II

≥ 2L glioblastoma multiforme

52

• Arm A: Calquence200mg BID

• Safety, ORR

• FPCD: Q1 2016

ACE-ST-209

• Arm B: Calquence400mg QD

• Data anticipated: H2 2019

NCT02586857

Oncology

CVRM

Respiratory

Other

23

Approved medicines

Enhertu(trastuzumab deruxtecan, HER2 ADC)

Late-stage development

Early development

Breast and gastric cancers

Trial

Population

Patients

Design

Endpoints

Status

Phase II

HER2-positive, unresectable and/or

230

Randomised, open label, sequential assignment

Primary endpoint ORR

FPCD: Q4 2017

DESTINY-Breast01

metastatic breast cancer patients

Enhertu

LPCD: Q4 2018

previously treated with trastuzumab

Secondary end points DoR, CBR, CBR,

Data readout: Q2 2019

NCT03248492

emtansine

PFS, OS

Partnered

Phase III

HER2-positive, unresectable and/or

600

Randomised open label parallel assignment

Primacy endpoint PFS

FPCD: Q4 2018

DESTINY-Breast02

metastatic breast cancer pretreated with

Enhertu

Data anticipated 2021

prior standard of care HER2 therapies,

Physicians choice of

Secondary endpoints OS, ORR, DoR, CBR

NCT03523585

including trastuzumab emtansine

Lapatinib + capecitabine

Partnered

Trastuzumab + capecitabine

Phase III

HER2-positive, unresectable and/or

500

Randomised open label parallel assignment

Primary endpoint PFS

FPCD: Q4 2018

DESTINY-Breast03

metastatic breast cancer patients

Enhertu

Data anticipated 2021

previously treated with trastuzumab and

Ado-trastuzumab emtansine

Secondary endpoints OS, ORR, DoR, CBR

NCT03529110

taxane

Partnered

Phase III

HER2-low, unresectable and/or

540

Randomised open label parallel assignment

Primary end point PFS

FPCD: Q4 2018

DESTINY-Breast04

metastatic breast cancer patients

Enhertu

Data anticipated 2021

Physicians choice of SoC chemo (choice of capecitabine,

Secondary end points OS, DoR, ORR

NCT03734029

eribulin, gemcitabine, paclitaxel or nab-paclitaxel)

Partnered

Phase II

HER2-overexpressing advanced gastric

220

Randomised open label parallel assignment

Primary end point ORR

FPCD: Q4 2017

DESTINY-Gastric01

or gastroesophageal junction

Enhertu

LPCD: Q2 2019

adenocarcinoma patients who have

SoC chemo

Secondary end points PFS, OS, DoR,

Data readout Q1 2020

NCT03329690

progressed on two prior treatment

DCR, TTF, range of PK endpoints

Partnered

regimens

Phase II

HER2-positive gastric cancer that cannot

72

Open label single group assignment

Primary endpoint ORR

FPCD: Q3 2019

DESTINY-Gastric02

be surgically removed or has spread

Enhertu

Secondary endpoints PFS, ORR, OS, DoR

Data anticipated: H2 2020

NCT04014075

Partnered

Oncology

CVRM

Respiratory

Other

24

Approved medicines

Enhertu(trastuzumab deruxtecan, HER2 ADC)

Late-stage development

Early development

Other cancers

Trial

Population

Patients

Design

Endpoints

Status

Phase II

HER2-expressing advanced colorectal

90

Non randomised single group assignment

Primary end point ORR

FPCD Q1 2018

NCT03384940

cancer

Enhertu

Secondary end points PFS, OS, DoR,

Data anticipated H2 2020

Partnered

range of PK endpoints

Phase II

HER2-over-expressing or mutated,

130

Non randomised parallel group assignment

Primary end point ORR

FPCD Q2 2018

NCT03505710

unresectable and/or metastatic NSCLC

Enhertu

Secondary end points DoR, PFS, OS

Data anticipated H2 2020

Partnered

Phase I

Advanced solid malignant tumours

278

Non randomised single group assignment

Primary end points number of subjects with

FPCD Q3 2015

NCT02564900

Enhertu

AEs, tumour response

Data read out Q3 2018

Secondary end points PK

Partnered

Oncology

CVRM

Respiratory

Other

25

Approved medicines

Lumoxiti

(moxetumomab pasudotox,CD22 mAb)

Late-stage development

Early development

Blood cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase III

Adults with relapsed or

80

• Multicentre, single-arm,open-label Phase III study

• Primary endpoint: rate of durable CR

• FPCD: Q2 2013

PLAIT

refractory HCL

Lumoxitii.v. at the recommended dose

(complete response): CR maintained for

• Data readout: Q3 2017

NCT01829711

> 180 days

• Primary endpoint met

• Secondary endpoints

Partnered

• Efficacy: CR rate, ORR, Duration of

CR and ORR, TTR, PFS

Safety and tolerability

PK and immunogenicity

Oncology

CVRM

Respiratory

Other

26

Approved medicines

Selumetinib (MEK inhibitor)

Late-stage development

Early development

Paediatric neurofibromatosis type 1, solid tumours

Trial

Population

Patients

Design

Endpoints

Status

Phase II

Paediatric NF1

50 (stratum 1)

• Single arm: selumetinib 25mg/m2BID with 2 strata:

Complete partial and complete response

FPCD: Q3 2015

SPRINT

25 (Stratum 2)

• Stratum 1: PN related morbidity present at enrolment

rate measured by volumetric MRI;

LPCD: Q4 2016

• Stratum 2: no PN related morbidity present at enrolment

Duration of response and functional

Data readout: Q1 2019

NCT01362803

outcomes/QoL

Primary endpoint met

Partnered

Phase Ib

Advanced solid tumours

80 (dose escalation

Phase Ib open-label trial of MK-8353 in combination with

DLTs

FPCD: Q1 2019

Selumetinib + MK-8353 (ERK

trial)

selumetinib in participants with advanced solid tumours

AEs

inhibitor)

Study drug discontinuations due to an

NCT03745989

AE

Partnered (Merck Lead

study)

Oncology

CVRM

Respiratory

Other

27

Approved medicines

Savolitinib (MET inhibitor)

Late-stage development

Early development

NSCLC and other cancers

Trial

Population

Patients

Design

Endpoints

Status

Phase I

Advanced NSCLC

85

• Dose escalation trial

Primary endpoint: safety and tolerability

FPCD: Q2 2013

NCT01985555

(all comers)

Conducted in China

Secondary endpoint: PK profile

Data anticipated: H2 2020

Partnered

Phase II

Lung PSC and other NSCLC

65

• Single arm trial: savolitinib QD

Primary endpoint: ORR

FPCD: Q1 2017

Secondary endpoint: PFS, safety

Data anticipated: H1 2020

NCT02897479

Conducted in China

parameters

Partnered

Oncology

CVRM

Respiratory

Other

28

Approved medicines

Cediranib (VEGF receptor inhibitor)

Late-stage development

Early development

Ovarian cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase IIb

PRR ovarian cancer - heavily

62

• Cediranib 30mg + Lynparza200mg BID

Primary endpoint:

• FPCD: Q1 2017

CONCERTO

pre-treated BRCAwt

• ORR

• LPCD: Q1 2019

NCT02889900

• Data readout: Q4 2019

Secondary endpoints:

• PFS, DoR, DCR, QoL, OS

Oncology

CVRM

Respiratory

Other

29

Approved medicines

Capivasertib (AKT inhibitor)

Late-stage development

Early development

Breast cancer, prostate cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase III

Locally advanced or

800

Double-blind randomised comparative study

PFS

FPCD Q3 2019

metastatic TNBC

Arm 1: capivasertib + paclitaxel

OS

Data anticipated: 2021+

NCT03997123

Arm 2: placebo + paclitaxel

CAPItello-290

Phase II (ESR)

Metastatic castration resistant

150

Randomised comparative

PFS

FPCD Q1 2014

prostate cancer eligible for

Arm 1: docetaxel + prednisolone + capivasertib

Data anticipated: H1 2020

NCT02121639

treatment with docetaxel

Arm 2: docetaxel + prednisolone + placebo

PROCAID

chemotherapy

Oncology

CVRM

Respiratory

Other

30

Oncology - early-stage development

Approved medicines

Imfinzi(PD-L1 mAb)

Late-stage development

Early development

Cancer

Trial

Compound

Population

Patients

Design

Endpoints

Status

Phase I/II

Imfinzi

Solid tumours

1,022

Dose escalation: 5 cohorts at Q2W and 1 cohort at Q3W

Safety

FPCD: Q3 2012

STUDY 1108

Dose expansion: 16 tumour type cohorts at the Q2W MTD

Optimal biologic dose

LPCD: Q4 2016

defined during dose escalation

Secondary endpoints include PK,

Data anticipated: H1 2020

NCT01693562

Dose exploration: cohort at 20mg Q4W

immunogenicity and antitumour activity

Global trial - nine countries

Phase I

Imfinzi, azacitidine

Myelodysplastic

79

Dose escalation and dose expansion trial

Safety and tolerability of monotherapy

FPCD: Q2 2014

syndrome

Part 1: Imfinzi

and combination

Data anticipated: H2 2020

NCT02117219

Part 2 Arm 1: Imfinziand tremelimumab

Secondary endpoints include duration of

Part 2 Arm 2: Imfinzi,tremelimumab and azacitidine

response, PFS and OS, PK and

Global trial - four countries

immunogenicity

Phase I

MEDI9090

Solid tumours

42

Multi-centre,open-label,single-arm trial for adult subjects

Safety, PK, number of subjects reporting

FPCD: Q3 2016

NCT02900157

US and Japan trial centers

infusion related reaction

Data anticipated: H1 2020

Phase II

Imfinzi

NSCLC

320

5 modules encompassing 13 cohorts

Primary outcome; ORR

FPCD: Q1 2018

HUDSON

Lynparza

Module 1;Imfinzi andLynparza

Secondary outcomes; efficacy including

Data anticipated: 2021+

vistusertib

Module 2; Imfinziand danvatirsen

OS, PFS, DCR, and safety and

NCT03334617

ceralasertib

Module 3; Imfinziand ceralasertib (AZD6738)

tolerability, DoR

(AZD6738)

Module 4; Imfinziand vistusertib

danvatirsen

Module 5; Imfinziand oleclumab

oleclumab

Module 6;Imfinzi andEnhertu

Enhertu

Module 7; Imfinziand cedirinib

cediranib

Open-label,biomarker-directed,multi-centre Phase II umbrella

trial in patients with NSCLC, who progressed on an anti-PD-1/PD-

L1 containing therapy

Phase II

Imfinzi

Stage III NSCLC

300

Arm A: Imfinzi

Primary

FPCD: Q4 2018

COAST

unresectable

Arm B: Imfinzi+ oleclumab

• OR per RECIST v1.1

Data anticipated: H2 2020

NCT03822351

Arm C: Imfinzi+ monalizumab

Phase II

Imfinzi

Resectable, early

160

Arm A: Imfinzi

Primary

FPCD: Q1 2019

NeoCOAST

stage NSCLC

Arm B: Imfinzi+ oleclumab

Major pathological response rate

Data anticipated: H2 2020

Arm C: Imfinzi+ monalizumab

NCT03794544

Arm D: Imfinzi+ danvatirsen

Oncology

CVRM

Respiratory

Other

32

Approved medicines

Imfinzi(PD-L1 mAb) +

Late-stage development

Early development

tremelimumab (CTLA-4 mAb)

Cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase Ib/II

Hepatocellular carcinoma

545

Arm A: Imfinzi+ tremelimumab

Primary endpoints: Safety & tolerability,

FPCD: Q4 2015

STUDY 22

Arm B: Imfinzi2L

DLTs

Data anticipated: H2 2020

Arm C: tremelimumab 2L

Secondary endpoints: ORR, DoR, OS

NCT02519348

Arm D: Imfinzi + tremelimumab

Arm E: Imfinziin combination with bevacizumab

Phase Ib

NSCLC

459

Dose escalation: minimum 5 cohorts exploring various treme

Primary endpoints:

FPCD: Q4 2013

STUDY 006

(Immunotx naïve and

Q4W and Imfinzii.v. Q4W dose combinations, higher dose

Safety

LPCD: Q4 2016

Immunotx pretreated patient

levels and alternate Q2 schedule added with amendment

Optimal biologic dose for the combination

Data anticipated: H1 2020

NCT02000947

cohorts)

Dose expansion: MTD for the combination in escalation to be

OR

explored in expansion

Secondary endpoints include antitumour

North American, EU and ROW trial centres

activity, PK and immunogenicity

Phase I

Solid tumours (basket trial)

380

Dose expansion: MTD for the combination in escalation to be

Primary endpoints:

FPCD: Q4 2014

STUDY 10

explored in expansion cohorts specific for each of 7 tumour

Safety

LPCD: Q2 2017

types

Optimal biologic dose for the combination

Data anticipated: H1 2020

NCT02261220

Dose exploration: 2cohorts exploring various Q4W treme and

Secondary endpoints include

Imfinzidose combinations and 2 cohorts exploring various Q2W

anti-tumour activity, PK/PD and

treme and Imfinzidose combinations

immunogenicity

North American, EU and ROW trial centres

Oncology

CVRM

Respiratory

Other

33

Approved medicines

Imfinzi(PD-L1 mAb) +

Late-stage development

Early development

monalizumab (NKG2a mAb)

Cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase I/II

Advanced solid tumours

501

Escalation phase

Primary endpoints:

FPCD: Q2 2016

• monalizumab + Imfinzii.v.

Safety

Data anticipated: 2021+

NCT02671435

Exploration Phase: Objective Response

Expansion phase

per RECIST

• monalizumab + Imfinzii.v. recommended dose

Secondary endpoints include tumour

Exploration phase

response (OR, DC, DoR, PFS and OS),

• monalizumab + Imfinzii.v. recommended dose + SoC systemic

immunogenicity, pharmacokinetics,

therapy with or without biologic agent and monalizumab in

pharmacodynamics

combination with a biologic agent in adult subjects with CRC

Global trial

Oncology

CVRM

Respiratory

Other

34

Approved medicines

Imfinzi(PD-L1 mAb) +

Late-stage development

Early development

MEDI0457 (DNA HPV Vaccine)

Head and neck squamous cell carcinoma (HNSCC)

Trial

Population

Patients

Design

Endpoints

Status

Phase Ib/IIa

HPV associated

50

Multi-centre, open label trial to evaluate the safety and efficacy of

Primary endpoints:

FPCD: Q3 2017

recurrent/metastatic head and

combination treatment with MEDI0457 and Imfinzi

Safety & Tolerability, ORR

Data anticipated: H2 2020

NCT03162224

neck cancer

Secondary endpoints:

PK, ADA, DCR, OS, PFS

Oncology

CVRM

Respiratory

Other

35

Approved medicines

AZD0466 (Bcl2/xL inhibitor)

Late-stage development

Early development

Cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase I

Advanced hematologic

102

Monotherapy dose escalation, consisting of two arms:

Primary: safety

FPCD: Q4 2019

malignancies or solid tumors

• Arm A: Patients with low risk for tumour lysis syndrome (solid

Secondary: PK, anti-tumour activity

Data anticipated: 2021+

NCT04214093

tumours, lymphomas, myelomas)

• Arm B: Patients with high risk for tumour lysis syndrome

(relapsed/refractory haem malignancies)

Oncology

CVRM

Respiratory

Other

36

Approved medicines

MEDI1191 (IL12 modRNA)

Late-stage development

Early development

Cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase I

Advanced solid tumours

87

First-time-in-human Phase I, open-label,dose-escalation and

Primary endpoint: safety and tolerability

FPCD: Q2 2019

NCT03946800

expansion study of MEDI1191 administered intratumourally as

Data anticipated: 2021+

monotherapy and in combination with Imfinzi

Secondary endpoints: PK,

immunogenicity and efficacy

Oncology

CVRM

Respiratory

Other

37

Approved medicines

AZD1390 (ATM inhibitor)

Late-stage development

Early development

Cancer

Trial

Population

Subjects

Design

Endpoints

Status

Phase I

Recurrent glioblastoma

132

• Primary: investigate the safety,

FPCD Q2 2018

eligible for re-irradiation, brain

• Designed to evaluate the safety, tolerability and PK of

tolerability, and MTD of AZD1390

Data anticipated: 2021

NCT03423628

metastases and

AZD1390 in combination with radiation therapy in patients with

administered in combination with radiation

leptomeningeal disease,

GBM and brain metastases from solid tumours

therapy in brain malignancies

newly-diagnosed

glioblastoma patients

• Dose and schedule of AZD1390 administration will be

adjusted during assessment of safety and tolerability during this

Phase I trial

Conducted across seven sites in USA and UK

Oncology

CVRM

Respiratory

Other

38

Approved medicines

Adavosertib (AZD1775, WEE-1 inhibitor)

Late-stage development

Early development

Ovarian cancer, solid tumours

Trial

Population

Patients

Design

Endpoints

Status

Phase II

Platinum-resistant (PR)

96

Arm B: paclitaxel + adavosertib

Primary endpoint: ORR

FPCD: Q1 2015

ovarian cancer

Arm C: carboplatin + adavosertib

LPCD: Q2 2018

D6010C00004

Secondary endpoints: DoR, PFS, OS,

Data readout: Q3 2019

NCT02272790

Global trial

DCR, safety and tolerability

Phase I

Advanced solid tumours

130

Dose escalation trial to determine MTD (adavosertib +

Safety and tolerability

FPCD: Q3 2015

Lynparza) followed by an expansions in SCLC

Secondary endpoints: ORR, DCR, DoR,

LPCD: Q4 2018

D6010C00005

Conducted in US, Canada

PFS

Data readout Q4 2019

NCT02511795

Phase I

Advanced solid tumours

56

Dose escalation trial to determine MTD (adavosertib + Imfinzi)

Safety and tolerability

FPCD: Q4 2015

LPCD: Q4 2018

D6015C00002

Conducted in US

Data readout Q4 2019

NCT02617277

Phase I

Advanced solid tumours

33

Part A: caffeine (200mg), omeprazole (20mg) and midazolam

Primary endpoints:

FPCD: Q4 2017

(1mL of 2mg/mL syrup) followed 7-14 days later by adavosertib

Part A: Plasma AUC, AUC0-t and CMAX

LPCD: Q4 2018

D6014C00006

225mg bid for 2.5 days plus caffeine (200mg), omeprazole

for cocktail parent compounds

Data readout Q4 2019

(20mg) and midazolam (1mL of 2mg/mL syrup) on day 3.

(midazolam, omeprazole and caffeine)

NCT03333824

Part B: 7-14 days after end of Part A, adavosertib 225mg BID for

Part B: dECG (differentiated ECG)

2.5 days.

intervals (QTcF) for absolute values and

Conducted in US

time-matched change from baseline

Phase I

Advanced solid tumours

48

adavosertib monotherapy once daily.

Safety and tolerability

FPCD: Q4 2017

LPCD: Q1 2019

D6014C00007

Conducted in US and Europe

Data readout Q4 2019

NCT03313557

Oncology

CVRM

Respiratory

Other

39

Approved medicines

MEDI2228 (BCMA antibody drug conjugate)

Late-stage development

Early development

Cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase I

Relapsed/refractory multiple

129

First-time-in-human Phase I, multi-centre,open-label,single-arm,

Primary endpoints:

• FPCD: Q2 2018

myeloma

dose-escalation, and dose-expansion trial for adult subjects

• Safety

• Data anticipated: 2021+

NCT03489525

• Determination of MTD

• Secondary endpoints: pPK,

immunogenicity, ORR, DCR, DoR, PFS,

OS

Oncology

CVRM

Respiratory

Other

40

Approved medicines

AZD2811 (AURN)

Late-stage development

Early development

Cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase I

Solid tumours

72

Arm 1: AZD2811 dose escalation

Safety and tolerability

FPCD: Q4 2015

NCT02579226

Arm 2: AZD2811 dose expansion SCLC

PK and efficacy

Data anticipated: H2 2020

Phase I

AML/high-risk MDS

130

Part A: AZD2811 monotherapy / azacitidine combination /

Safety and tolerability

FPCD: Q3 2017

venetoclax combination dose escalation cohorts

PK and efficacy

Data anticipated: 2021+

NCT03217838

• Part B: AZD2811 monotherapy / azacitidine combination /

venetoclax combination dose expansions to further explore the

tolerability, PK and clinical activity

Oncology

CVRM

Respiratory

Other

41

Approved medicines

AZD4573 (CDK9 inhibitor)

Late-stage development

Early development

Cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase I

Relapsed/refractory

45

Dose escalation in relapsed/refractory haematological

Primary:

FPCD: Q4 2017

haematologic malignancies

malignancies

• safety/PK;

Data anticipated: H2 2020

NCT03263637

Secondary:

AZD4573 will be administered in 2 parallel arms (1-6 cohorts of

• efficacy

dose escalations) based on the haematological malignancy

Oncology

CVRM

Respiratory

Other

42

Approved medicines

AZD4635 (A2AR inhibitor)

Late-stage development

Early development

Cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase I

Phase Ia: patients with

306

Phase Ia - solid tumours or mCPRC:

Primary outcome measure:

FPCD: Q2 2016

advanced solid tumours

AZD4635 monotherapy

Safety and tolerability

NCT02740985

AZD4635 + Imfinzi

Phase Ib:

AZD4635 + abiraterone

Secondary outcome measures:

Post-immunotherapy NSCLC

AZD4635 + enzalutamide

Preliminary assessment of anti-tumour

Other post-immunotherapy

AZD4635 + Imfinzi + oleclumab

activity

AZD4635 + docetaxel.

solid tumours

Phase Ib: AZD4635 monotherapy or AZD4635 + Imfinzidose

Immune checkpoint-naïve

expansions in NSCLC, mCRPC, CRC and other post-

mCRPC Immune checkpoint-

immunotherapy and immune checkpoint-naïve solid tumours

naïve CRC

Other immune checkpoint-

Conducted at sites in the US

naïve solid tumours

Phase I

Healthy male volunteers

21

Part A 2-period randomised crossover study of single doses of

Primary outcome measures:

FPCD: Q4 2018

AZD4635, nanosuspension or solid oral formulation in fasted

Cmax and exposure (AUC) of AZD4635

LPCD: Q2 2019

NCT03710434

state

solid oral formulation and nano-

Part B, 4-period,open-label, randomised, crossover study of

suspension

single doses of AZD4635 in the same subjects from Part A to

assess food effect, pH effect and formulation variants

Both parts conducted at a site in the UK

Phase II

Prostate cancer

60

ARM 1: AZD4635 + Imfinzi

Primary outcome measure: Efficacy;

FPCD: Q3 2019

NCT04089553

ARM 2: AZD4635 + oleclumab

(ORR and PSA response)

Conducted at sites in the US

Secondary outcome measure: Efficacy,

PK, safety and tolerability

Phase I

Japanese patients with

12

AZD4635 dose escalation

Primary outcome measure:

FPCD: Q3 2019

NCT03980821

advanced solid malignancies

Conducted at sites in Japan

Safety and tolerability

Secondary outcome measure:

PK and preliminary anti-tumour activity

Oncology

CVRM

Respiratory

Other

43

Approved medicines

AZD5069 (CXCR2 antagonist)

Late-stage development

Early development

Cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase Ib/II

Metastatic pancreatic ductal

16

Dose escalation and expansion arms:

• Safety/efficacy trial

FPCD: Q1 2016

carcinoma

LPCD: Q3 2018

NCT02583477

Imfinziin combination with nab-paclitaxel and gemcitabine

Data anticipated: H2 2020

Imfinziin combination with AZD5069

Oncology

CVRM

Respiratory

Other

44

MEDI5083 (CD40 ligand fusion protein ) + Imfinzi(PD-L1 mAb)

Cancer

Approved medicines Late-stage development Early development

Oncology

CVRM

Trial

Population

Patients

Design

Endpoints

Status

Phase I

Advanced solid tumours

204

Dose-escalation phase

Primary endpoints:

FPCD: Q1 2017

Part 1: MEDI5083

Safety

Data anticipated: H1 2020

NCT03089645

Part 2: MEDI5083 + Imfinzii.v.

Determination of MTD

Secondary endpoints: preliminary anti-

Dose expansion phase

tumour activity, pharmacokinetics,

Part 3: MEDI5083 recommended dose + Imfinzii.v.

pharmacodynamics, and immunogenicity

US and Australian trial centres

Respiratory

Other

45

Approved medicines

AZD5153 (BRD4 inhibitor)

Late-stage development

Early development

Cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase I/Ib

Relapsed/refractory solid

60

Monotherapy dose escalation in advanced solid tumours and

Primary: safety

FPCD: Q2 2017

NCT03205176

tumours, lymphomas

lymphomas

Secondary: efficacy, PK

Data anticipated: H2 2020

Dose escalation of AZD5153 in combination with Lynparzain

platinum resistant/refractory HGS patients.

Oncology

CVRM

Respiratory

Other

46

Approved medicines

MEDI5395 (rNDV GMCSF)

Late-stage development

Early development

Cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase I

Select advanced solid

164

First-time-in-human Phase I, open-label,dose-escalation and

Primary endpoint: safety and tolerability

FPCD: Q4 2019

NCT03889275

tumours

expansion study of MEDI5395 in combination with Imfinzi

Secondary endpoints: PK, PD,

Data anticipated: 2021+

immunogenicity and efficacy

Oncology

CVRM

Respiratory

Other

47

Approved medicines

MEDI5752 (PD-1/CTLA-4 bispecific mAb)

Late-stage development

Early development

Cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase I

Advanced solid tumours

272

Open-label,dose-escalation and dose-expansion

Primary endpoints:

FPCD: Q2 2018

• dose-escalation: safety & determination

Data anticipated: 2021+

NCT03530397

Dose-escalation: MEDI5752 i.v.

of MTD

• dose-expansion: assessment of

Dose-expansion : 2 cohort

antitumour activity based on OR

Secondary endpoints:

• PK, ADA, tumoural baseline PD-L1,

assessment of antitumour activity

based on OR, DoR, DC, PFS, OS

Oncology

CVRM

Respiratory

Other

48

Approved medicines

AZD5991 (MCL1 inhibitor)

Late-stage development

Early development

Cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase I

Relapsed/refractory

177

• Arm1: monotherapy dose escalation expansions in

Primary: safety

FPCD: Q3 2017

haematologic malignancies

relapsed/refractory haematological malignancies

Secondary: efficacy, PK

Data anticipated: H2 2020

NCT03218683

• Arm2: combination dose escalation (AZD5991+venetoclax) in

relapsed/refractory AML;. Four dose escalation cohorts.

• i.v. route of administration

• US only

Oncology

CVRM

Respiratory

Other

49

Approved medicines

Ceralasertib (AZD6738, ATR inhibitor)

Late-stage development

Early development

Cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase I

Solid tumours

250

Arm 1: ceralasertib + carboplatin

Safety and tolerability

FPCD: Q4 2014

Arm 2: ceralasertib dose escalation, ceralasertib + Lynparza

PK and efficacy

Data anticipated: 2021+

NCT02264678

Arm 3: ceralasertib + Imfinzi

Trial conducted in North America, Europe and South Korea

Phase I

HNSCC

44

Window of opportunity

Biomarker change

FPCD: Q4 2017

Arm 1: ceralasertib

Data anticipated: H2 2020

NCT03022409

Arm 2:Lynparza

Trial conducted in US, France, Taiwan and the UK

Oncology

CVRM

Respiratory

Other

50

Approved medicines

Danvatirsen (AZD9150, STAT3 inhibitor)

Late-stage development

Early development

Cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase Ib/II

HNSCC

405

Dose escalation advanced solid and blood cancers

Safety/efficacy trial

FPCD: Q3 2015

• Arm A1: AZD9150/Imfinzi

LPCD: Q2 2019

NCT02499328

• Arm A2 : AZD5069/Imfinzi

Data anticipated: 2021

• Arm A4: AZD9150/Imfinzi/treme

• Arm A5: AZD5069/Imfinzi/treme

Dose expansion 2L HNSCC:

• Arm B1: AZD9150

• Arm B2: AZD5069

• Arm B3: AZD9150/Imfinzi

• Arm B4: AZD5069/Imfinzi

• Arm B5: AZD9150 mono

• Arm B6: AZD5069 mono

• Arm B7: AZD9150/Imfinzi(1L HNSCC)

• Arm B8: AZD9150 Q2W/Imfinzi(1L HNSCC)

Phase Ib/II

NSCLC, advanced solid

213

Dose escalation advanced solid and blood cancers

Safety/efficacy trial

FPCD: Q1 2018

tumours

• Arm A1: AZD9150 alternate week/Imfinzi

Data anticipated: 2021

NCT03421353

• Arm A2-A5 : AZD9150/Imfinzi+ SoC chemo

Dose expansion 1L HNSCC:

• Arm D1/D2/D3: AZD9150 i.v. vs s.c. formulations/Imfinzi

(advanced solid tumours)

Oncology

CVRM

Respiratory

Other

51

Approved medicines

Oleclumab (MEDI9447, CD73 mAb)

Late-stage development

Early development

Cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase I

Advanced malignancies

310

Dose escalation phase

Primary endpoints:

FPCD: Q3 2015

oleclumab i.v.

Safety

Data anticipated: 2021

NCT02503774

oleclumab i.v. + Imfinzii.v.

Determination of MTD

Secondary endpoints include preliminary

Dose expansion phase

anti-tumour activity, PK, PD,

oleclumab i.v. recommended dose + Imfinzii.v.

immunogenicity and biomarker activity

US, South Korean and Australian trial centres

Phase Ib/II

Pancreatic

309

Arm A1: gemcitabine and nab paclitaxel i.v.

Primary endpoints:

FPCD: Q2 2018

1L and 2L with prior

Arm A2: gemcitabine and nab paclitaxel i.v. + oleclumab i.v.

Safety and anti-tumour activity

Data anticipated: 2021

NCT03611556

gemcitabine-based

Arm A3: gemcitabine and nab paclitaxel i.v. + oleclumab i.v. +

chemotherapy

Imfinzi i.v.

Secondary endpoints include PFS, PK,

Arm B1: mFOLFOX (oxaliplatin, leucovorin, 5-FU) i.v.

immunogenicity, safety and anti-tumour

Arm B2: mFOLFOX (oxaliplatin, leucovorin, 5-FU) i.v. +

activity

oleclumab i.v.

Arm B3: mFOLFOX (oxaliplatin, leucovorin, 5-FU) i.v. +

oleclumab i.v. + Imfinzii.v.

US, Norway, Spain and Australian trial centres

Phase Ib/II

NSCLC

98

Arm A: oleclumab i.v. + Tagrisso

Primary endpoints:

FPCD: Q2 2018

Safety

Data anticipated: 2021+

NCT03381274

US, South Korean and Taiwan trial centres

ORR

Secondary endpoints:

• DoR, DCR, PFS, OS, PK and

immunogenicity

Oncology

CVRM

Respiratory

Other

52

Approved medicines

AZD9496 (SERD, oral)

Late-stage development

Early development

Breast cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase I

ER+ breast cancer

c. 50

• This is an open label randomised multicentre pre-surgical

Primary outcome measures: PD changes

FPCD: Q4 2017

NCT03236974

pharmacodynamics trial to compare and assess the biological

to ER expression following treatment with

Data readout: Q4 2019

effects of AZD9496 and Faslodexin postmenopausal women

AZD9496 or Faslodex

Secondary outcome measures:

with ER+, HER2- primary breast cancer. Patients will receive

pharmacodynamics changes to Ki67 and

AZD9496 or Faslodexand will have a pre-dose and an on-

PgR expression following treatment with

treatment core biopsy after 5-14 days of commencing

AZD9496 or Faslodex

treatment.

Safety, tolerability + pharmacokinetics

Oncology

CVRM

Respiratory

Other

53

Approved medicines

AZD9833 (SERD, oral)

Late-stage development

Early development

Breast cancer

Trial

Population

Patients

Design

Endpoints

Status

Phase I

ER+ breast cancer

240

• This is a Phase I open label multicentre trial of AZD9833

Primary outcome measures: safety and

• FPCD: Q4 2018

administered orally in patients with advanced ER+ HER2

tolerability

NCT03616587

negative breast cancer. The trial design allows an escalation

Secondary outcome measures: multiple

of dose with intensive safety monitoring to ensure the safety

dose PK of AZD9833 alone and in

of patients. The trial will determine the maximum tolerated

combination with palbociclib

dose of AZD9833 as monotherapy and in combination with

antitumour activity

palbociclib. In addition, randomised expansion cohort(s) at

potential therapeutic dose(s) in patients will be enrolled to

further determine the safety, tolerability, pharmacokinetics

and biological activity of AZD9833 alone and in combination

with palbociclib

Oncology

CVRM

Respiratory

Other

54

BioPharmaceuticals - approved medicines and late-stage pipeline

Approved medicines

Farxiga

(SGLT2 inhibitor)

Late-stage development

Early development

Heart failure and chronic kidney disease

Trial

Population

Patients

Design

Endpoints

Status

Phase III

CHF patients with HFrEF

4,744

Arm 1: Farxiga10mg or 5 mg QD + SoC therapy

Primary endpoint: time to the first

FPCD: Q1 2017

Dapa-HF

Arm 2: placebo + SoC therapy

occurrence of any of the components of

LPCD Q4 2018

the composite: CV death or

Data readout: Q3 2019

NCT03036124

Global trial - 20 countries

hospitalisation for HF or an urgent HF

Primary endpoint met

visit

Phase III

Patients With CKD

4,000

Arm 1: Farxiga10mg or 5 mg QD

Primary endpoint: time to the first

FPCD: Q1 2017

Dapa-CKD

Arm 2: placebo

occurrence of any of the components of

LPCD: Q1 2019

Global trial - 21 countries

the composite: ≥50% sustained decline

• Data anticipated: 2021

NCT03036150

in eGFR or reaching ESRD or CV death

or renal death

Phase III

CHF patients with HFpEF

6,100

Arm 1: Farxiga10mg QD

Primary endpoint: time to the first

FPCD: Q4 2018

DELIVER

Arm 2: placebo

occurrence of any of the components of

Data anticipated: 2021+

Global trial - 21 countries

the composite: CV death or

NCT03619213

hospitalisation for HF or an urgent HF

visit

Phase III

CHF patients with HFpEF

500

Arm 1: Farxiga10mg QD

• Dual primary endpoint: 1) change from

FPCD: Q2 2019

DETERMINE-preserved

Arm 2: placebo

baseline in 6 min walking distance at

Data anticipated: H1 2020

NCT03877224

Global trial - 12 countries

Week 16 2) change from baseline in

KCCQ-TSS at Week16

Phase III

CHF patients with HFrEF

300

Arm 1: Farxiga10mg QD

Primary endpoint: change from

FPCD: Q2 2019

DETERMINE-reduced

Arm 2: placebo

baseline in 6 min walking distance at

Data anticipated: H1 2020

NCT03877237

Global trial - 9 countries

Week 16

Oncology

CVRM

Respiratory

Other

56

Approved medicines

Brilinta(P2Y12 receptor antagonist)

Late-stage development

Early development

Cardiovascular risk reduction

Trial

Population

Patients

Design

Endpoints (primary)

Status

Phase III

Patients with type-2 diabetes

19,000

Arm 1: Brilinta60mg BiD

Primary endpoint: composite of CV

FPCD: Q1 2014

THEMIS

and coronary artery disease

Arm 2: placebo BID

death, non-fatal MI and non-fatal stroke

LPCD: Q2 2016

without a previous history of

on a background of acetylsalicylic acid if not contra-indicated or

Data readout: Q1 2019

NCT01991795

MI or stroke

not tolerated

Secondary endpoints:

Primary endpoint met

Global trial - 42 countries

Prevention of CV death

Prevention of MI

Prevention of ischaemic stroke

Prevention of all-cause death

Phase III

Patients with acute ischaemic

11,000

Arm 1: Brilinta90mg BiD

Primary endpoint:

FPCD: Q1 2018

THALES

stroke or transient ischaemic

Arm 2: placebo BiD

Prevention of the composite of

LPCD: Q4 2019

attack

on a background of acetylsalicylic acid if not contra-indicated or

subsequent stroke and death at 30 days

Data readout: Q1 2020

NCT03354429

not tolerated

Primary endpoint met

Global trial - 28 countries

Secondary endpoints include:

Prevention of subsequent ischaemic

stroke at 30 days

Reduction of overall disability at 30 days

Phase III

Peadiatric patients (2-18 years

182

• Arm 1: Brilinta15, 30 or 45mg (dose based on subject weight)

Primary endpoint: the number of vaso-

FPCD: Q3 2018

HESTIA3

old) with sickle cell disease

Arm 2: placebo

occlusive crisis which is the composite

Data anticipated: 2021

NCT03615924

Global trial - 18 countries

of painful crisis and/or acute chest pain

Oncology

CVRM

Respiratory

Other

57

Approved medicines

Lokelma(sodium zirconium cyclosilicate)

Late-stage development

Early development

Hyperkalaemia

Trial

Population

Patients

Design

Endpoints

Status

Phase II/III

Hyperkalaemia

103

Arm 1: Lokelma5g TID for 48 hours

Primary endpoint: exponential rate of

FPCD: Q2 2017

Dose-response Study in

Arm 2: Lokelma10g TID for 48 hours

change in serum potassium

LPCD: Q1 2018

Japan

Arm 3: placebo TID for 48 hours

Data readout: Q3 2018

NCT03127644

Japan

Primary endpoint met

Phase III

Hyperkalaemia

150

Arm 1: Open-labelLokelma10g TID for up to 72 hrs followed

Primary endpoint: safety and tolerability

FPCD: Q3 2017

by Lokelma5g QD for 12 months. Option to uptitrate to 10

as measured by adverse events

LPCD: Q3 2019

NCT03172702

and15g QD or downtitrate to 5g QOD (or 2.5g QD)

reporting, vital signs, ECGs, physical

Data readout: Q3 2019

J-LTS

examinations and safety laboratory

Primary endpoint met

Japan

measurements

Phase IIIb

Patients on haemodialysis

180

Arm 1: Lokelma5g QD for 8 weeks on non-dialysis days.

Primary endpoint: proportion of patients

FPCD: Q4 2017

DIALIZE

with persistent pre-dialysis

Option to uptitrate to 10 and15g QD.

who maintain a pre-dialysis serum K

LPCD: Q4 2018

hyperkalaemia

Arm 2: placebo QD for 8 weeks on non-dialysis days

between 4.0-5.0 mmol/L on 3 out of 4

Data readout: Q1 2019

NCT03303521

dialysis treatments following the long

Primary endpoint met

Global trial - four countries

interdialytic interval

Phase II

Patients with chronic heart

280

Arm 1: Lokelma5g QD for 12 weeks. Option to uptitrate to 10

Primary endpoint: difference between

FPCD: Q3 2018

PRIORITIZE HF

failure and hyperkalaemia or

and 15g QD or downtitrate to 5g QOD

Lokelmaand placebo in RAAS (renin-

Data readout: H2 2020

at high risk of developing

Arm 2: placebo QD for 12 weeks

angiotensin-aldosterone system)

NCT03532009

hyperkalaemia

Global trial - nine countries

blockade treatment.

Oncology

CVRM

Respiratory

Other

58

Approved medicines

Roxadustat (HIF-PH inhibitor)

Late-stage development

Early development

Anaemia

Trial

Population

Patients

Design

Endpoints

Status

Phase III

Anaemia in CKD in patients

922

Arm 1: roxadustat

Primary endpoint: Haemoglobin response

FPCD: Q4 2012

ANDES

not receiving dialysis

Arm 2: placebo

LPCD: Q3 2018

NCT01750190

Global trial

Data readout: Q4 2018

Primary endpoint met

Partnered

Sponsored by FibroGen

Phase III

597

Arm 1: roxadustat

Primary endpoint: Haemoglobin response

FPCD: Q2 2013

ALPS

Arm 2: placebo

LPCD: Q4 2017

NCT01887600

Global trial

Data readout: Q3 2018

Primary endpoint met

Partnered

Sponsored by Astellas

Phase III

616

Arm 1: roxadustat

Primary endpoint: Haemoglobin response

FPCD: Q1 2014

DOLOMITES

Arm 2: darbepoetin alfa

Data anticipated: H1 2020

NCT02021318

Global trial

Sponsored by Astellas

Partnered

Phase III

2,781

Arm 1: roxadustat

Primary efficacy endpoint: Haemoglobin

FPCD: Q3 2014

OLYMPUS

Arm 2: placebo

response

LPCD: Q4 2018

NCT02174627

Global trial

Data readout: Q4 2018

Primary safety objective: Contribute CV

Primary endpoint met

safety data to pooled safety

Sponsored by AstraZeneca

analyses across the Phase III program

Phase III

Anaemia in CKD in patients

2,133

Arm 1: roxadustat

Primary efficacy endpoint: Haemoglobin

FPCD: Q3 2014

ROCKIES

receiving dialysis

Arm 2: epoetin alfa

response

LPCD: Q3 2018

NCT02174731

Global trial

Data readout: Q4 2018

Primary safety objective:Contribute CV

Primary endpoint met

safety data to pooled safety

Sponsored by AstraZeneca

analyses across the Phase III program

Phase III

741

Arm 1: roxadustat

Primary endpoint: Haemoglobin response

FPCD: Q4 2014

SIERRAS

Arm 2: epoetin alfa

LPCD: Q3 2018

NCT02273726

Global trial

Data readout: Q4 2018

Primary endpoint met

Partnered

Sponsored by FibroGen

Phase III

838

Arm 1: roxadustat

Primary endpoint: Haemoglobin response

FPCD: Q4 2014

PYRENEES

Arm 2: epoetin alfa or darbepoetin alfa

LPCD: Q3 2018

NCT02278341

Global trial

Data readout: Q3 2018

Primary endpoint met

Partnered

Sponsored by Astellas

Oncology

CVRM

Respiratory

Other

59

Approved medicines

Roxadustat (HIF-PH inhibitor)

Late-stage development

Early development

Anaemia

Trial

Population

Patients

Design

Endpoints

Status

Phase III

Anaemia in newly initiated

1,043

Arm 1: roxadustat

Primary endpoint: Haemoglobin response

FPCD: Q4 2013

HIMALAYAS

dialysis patients

Arm 2: epoetin alfa

LPCD: Q3 2018

Data readout: Q4 2018

NCT02052310

Global trial

Primary endpoint met

Partnered

Sponsored by FibroGen

Phase III

Anaemia in lower risk MDS

184

Open label roxadustat lead-in

Primary endpoint: Proportion of patients

FPCD: Q3 2017

patients

Arm 1: roxadustat

achieving transfusion independence

Data anticipated: 2021

NCT03263091

Arm 2: placebo

Sponsored by FibroGen

Partnered

US/global trial

Phase II/III

Anaemia in lower risk MDS

175

Open label roxadustat lead-in

Primary endpoint: Haemoglobin

patients

Arm 1: roxadustat

response

FPCD: Q2 2018

NCT03303066

Arm 2: placebo

Data anticipated: 2021

Partnered

China

Sponsored by FibroGen

Phase II

Anemia in patients receiving

100

US

Primary endpoint: Maximum change in

FPCD: Q3 2019

chemotherapy treatment for

hemoglobin within 16 weeks from

Data anticipated: H2 2020

NCT04076943

non-myeloid malignancies

baseline without RBC transfusion

Sponsored by FibroGen

Partnered

Oncology

CVRM

Respiratory

Other

60

Approved medicines

Eklira/Tudorza (LAMA, DPI)

Late-stage development

Early development

COPD

Trial

Population

Number of patients

Design

Endpoints

Status

Phase I

Healthy Chinese

18

Open-label,2-period ascending dose incomplete block, cross-over

• To investigate the PK of aclidinium

FPCD: Q2 2018

subjects

trial

bromide and its metabolites after single

Data anticipated: 2021

NCT03276052

and multiple doses (BID) of aclidinium

• Arm 1: aclidinium bromide 200 μg DPI

bromide 200 μg, 400 μg and 800 μg

• Arm 2: aclidinium bromide 400 μg DPI

• To evaluate the safety, and tolerability

• Arm 3: aclidinium bromide 800 μg DPI

of aclidinium bromide 200 μg, 400 μg and

800 μg after single and multiple dose

Global trial - one Country

administration (BID)

Oncology

CVRM

Respiratory

Other

61

Approved medicines

Duaklir Genuair (LAMA/LABA, DPI)

Late-stage development

Early development

COPD

Trial

Population

Patients

Design

Endpoints

Status

Phase III

Patients with stable COPD

1,060

Arm 1: Duaklir Genuair400/12 μg DPI

Primary endpoints:

FPCD: Q1 2017

AVANT

Arm 2: aclidinium bromide 400 μg DPI

Change from baseline in one hour

Data anticipated: 2021

NCT03022097

Arm 3: formoterol fumarate 12 μg DPI

morning post-dose dose FEV1 Duaklir

• Arm 4: tiotropium 18 μg DPI

Genuair400/12 μg compared to

Aclidinium bromide at Week 24

Change from baseline in morning pre-

Global trial - five countries

dose (trough) FEV1 of Duaklir Genuair

400/12 μg compared to Formoterol

fumarate at Week 24

Change from baseline in trough FEV1 of

Aclidinium bromide 400 µg compared to

placebo at Week 24

Oncology

CVRM

Respiratory

Other

62

Approved medicines

Breztri(PT010, LAMA/LABA/ICS, pMDI)

Late-stage development

Early development

COPD

Trial

Population

Patients

Design

Endpoints

Status

Phase III

Moderate to very severe

500

Treatments (52-week treatment period)

Primary endpoints:

FPCD: Q3 2015

COPD

BGF (budesonide, glycopyrronium, and formoterol fumarate)

Bone mineral density sub-study endpoint.

LPCD: Q3 2016

MDI 320/14.4/9.6µg BID pMDI

change from baseline in BMD of the

Data readout: Q1 2018

NCT02536508

GFF (glycopyrronium and formoterol fumarate) MDI 14.4/9.6µg

lumbar spine measured using DXA (dual

Primary endpoints met

BID pMDI

energy X-ray absorptiometry) scans of

BFF (budesonide and formoterol fumarate) MDI 320/9.6µg BID

L1-L4 at week 52

pMDI

Ocular sub-study safety endpoint change

Randomised, double-blind,chronic-dosing,multi-centre

from baseline in LOCS III at week 52

Country - US

Phase III

Moderate to very severe

8,588

Treatments (1-year treatment period)

Primary endpoint: rate of moderate or

FPCD: Q3 2015

ETHOS

COPD

BGF MDI 320/14.4/9.6µg BID pMDI

severe COPD exacerbations

LPCD: Q3 2018

BGF MDI 160/14.4/9.6µg BID pMDI

Data readout: Q3 2019

NCT02465567

BFF MDI 320/9.6µg BID pMDI

Secondary endpoint: time to first

Primary endpoint met

GFF MDI 14.4/9.6µg BID pMDI

moderate or severe COPD exacerbation

Randomised, double-blind,multi-centre and parallel-group

Multi-country

Phase III

Moderate to very severe

1,800

Treatments (24-week treatment period)

Primary Endpoints:

FPCD: Q3 2015

KRONOS

COPD

BGF MDI 320/14.4/9.6µg BID pMDI

FEV1area under curve from 0 to 4 hours

LPCD: Q2 2017

GFF MDI 14.4/9.6µg BID pMDI

(AUC0-4) over 24 weeks (BGF MDI vs.

Data readout: Q1 2018

NCT02497001

BFF MDI 320/9.6µg BID pMDI

BFF MDI and BGF MDI vs. Symbicort

8/9 Primary endpoints met

Symbicort Turbuhaler 400/12µg BID DPI

Turbuhaler)

Change from baseline in morning pre-

Randomised, double-blind,parallel-group, and chronic dosing and

dose trough FEV1over 24 weeks (BGF

multi-centre

MDI vs. GFF MDI)

TDI focal score over 24 weeks (BGF

MDI vs. BFF MDI and BGF MDI vs. GFF

Multi-country

MDI)

Phase III

Moderate to very severe

324

Treatments (28-week treatment period)

Primary outcome measures:

FPCD Q3 2016

COPD

BGF MDI 320/14.4/9.6µg BID pMDI

Long-term safety and tolerability (52

LPCD Q4 2017

NCT03262012

GFF MDI 14.4/9.6µg BID pMDI

weeks): adverse events, 12-lead ECG,

Data readout: Q3 2018

BFF MDI 320/9.6µg BID pMDI

laboratory tests, vital signs

Primary safety endpoint met

Symbicort Turbuhaler 400/12µg BID DPI

Randomised, double-blind,parallel-group, chronic dosing,

multicenter

Country: Japan