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    AZN   GB0009895292

ASTRAZENECA PLC

(AZN)
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AstraZeneca aims to redefine breast cancer care with new data across the treatment spectrum at SABCS 2022

11/22/2022 | 10:08am EST

Data will show clinical opportunity in HR-positive advanced breast cancer for potential first-in-class AKT inhibitor capivasertib and next-generation oral SERD camizestrant

Enhertu data will reinforce potential to set new standards in HER2-targetable disease

Data for antibody drug conjugate datopotamab deruxtecan will demonstrate potential in HR-positive and triple-negative breast cancer

AstraZeneca will present new data advancing its ambition to redefine care at the 2022 San Antonio Breast Cancer Symposium (SABCS), 6-10 December 2022.

Twelve AstraZeneca medicines and potential new medicines will be featured in 55 presentations, including five oral presentations, showcasing the Company's growing leadership across different subtypes and stages of breast cancer.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "Our data at SABCS are strong validation of our clinical strategy to provide next-generation treatment solutions for patients with nearly all major types of breast cancer. We are excited to share results from the pivotal CAPItello-291 trial, which will support the opportunity of our novel AKT inhibitor capivasertib for patients with HR-positive disease. We also look forward to presenting defining data from the SERENA-2 Phase II trial that will demonstrate the potential of our next-generation SERD camizestrant to improve upon currently available endocrine therapies for patients with ER-driven disease."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "As we close another year of breakthroughs in breast cancer, our presence at SABCS will showcase the opportunity for our portfolio to shape clinical practice and redefine care across subtypes and stages of this disease. Compelling results for potential new medicines capivasertib and camizestrant as well as new data from antibody drug conjugates Enhertu and datopotamab deruxtecan will underscore our focus on addressing the greatest unmet needs and delivering personalised treatment for more patients with breast cancer."

Aiming to set new standards of care across HER2-positive metastatic breast cancer

Two late-breaking presentations from the DESTINY-Breast clinical programme will highlight the efficacy of Enhertu (trastuzumab deruxtecan) treatment in patients with HER2-positive metastatic breast cancer across lines of therapy.

Updated results from the DESTINY-Breast03 Phase III trial of Enhertu versus trastuzumab emtansine (T-DM1) in patients with HER2-positive breast cancer previously treated with trastuzumab and a taxane will be presented, including updated progression-free survival (PFS) data and overall survival (OS) results.

In addition, primary results from the DESTINY-Breast02 Phase III trial will be presented, further demonstrating the clinical benefit of Enhertu compared to conventional chemotherapy-based regimens in patients with HER2-positive metastatic breast cancer previously treated with T-DM1.

Data will also be presented from the ROSET-BM retrospective study and DEBBRAH Phase II trial further confirming Enhertu activity in patients with HER2-positive or HER2-low metastatic breast cancer with active or stable brain metastases.

Reshaping treatment expectations in HR-positive advanced breast cancer

A late-breaking presentation will illustrate the Company's focus on addressing endocrine resistance in advanced HR-positive breast cancer.

Detailed data will be shared from the CAPItello-291 Phase III trial of the AKT inhibitor capivasertib in combination with Faslodex (fulvestrant) versus Faslodex alone in endocrine-resistant, HR-positive, HER2-low or negative advanced breast cancer. CAPItello-291 recently met both primary endpoints, demonstrating improvement in PFS in the overall patient population and in a prespecified biomarker subgroup of patients whose tumours had qualifying alterations in the PIK3CA, AKT1 or PTEN genes.

Several presentations will establish the clinical potential of the next-generation oral selective oestrogen receptor degrader (SERD) camizestrant as a monotherapy or in combination for patients with oestrogen receptor positive (ER-positive) advanced breast cancer.

- A late-breaking presentation will highlight detailed results from the positive SERENA-2 Phase II trial of camizestrant versus Faslodex in advanced ER-positive breast cancer.

- Analyses from further cohorts of the SERENA-1 Phase I trial of advanced ER-positive breast cancer will also be presented, which will show the potential to combine camizestrant with abemaciclib, a CDK4/6 inhibitor.

- A spotlight poster will feature data showing promising preclinical activity with camizestrant in ER-positive breast cancer when used in double and triple combinations with CDK4/6, mTOR, AKT or PI3K inhibitors, in ESR1 wild-type and mutated models.

Additionally, several presentations will showcase AstraZeneca's commitment to transforming the treatment landscape for HR-positive breast cancer with antibody drug conjugates (ADCs) and by identifying new tumour subtypes that may respond to targeted therapies.

- A poster presentation of results from the TROPION-PanTumor01 Phase I trial will characterise the safety and encouraging clinical activity of datopotamab deruxtecan in patients with heavily pre-treated HR-positive, HER2-negative inoperable or metastatic breast cancer. Datopotamab deruxtecan is also being tested in these patients in earlier lines of treatment in the randomised TROPION-Breast01 Phase III trial.

- Multiple poster presentations will share results for potential diagnostic tools to better identify and optimise treatment for patients across the spectrum of HER2 expression, including those with HER2-low tumours who may benefit from treatment with Enhertu.

- Data from various subgroup analyses from the DESTINY-Breast04 Phase III trial will reinforce the clinical meaningfulness of HER2-low as an actionable patient segment in patients with metastatic breast cancer.

Redefining care for triple-negative breast cancer (TNBC)

Two spotlight poster discussions will share results from the BEGONIA Phase Ib/II trial testing Imfinzi (durvalumab) combinations in advanced or metastatic TNBC, showing the potential to drive improved outcomes with the addition of ADCs.

Additionally, updated results from the TROPION-PanTumor01 Phase I trial of datopotamab deruxtecan monotherapy will show encouraging and durable anti-tumour activity, and a manageable safety profile in heavily pre-treated patients with metastatic TNBC. The TROPION-Breast02 Phase III trial is evaluating datopotamab deruxtecan as 1st-line therapy for patients with metastatic TNBC.

Enhertu and datopotamab deruxtecan are developed and commercialised in collaboration with Daiichi Sankyo worldwide, except in Japan where Daiichi Sankyo maintains exclusive rights.

Key AstraZeneca presentations during SABCS 2022

Lead author

Abstract title

Presentation details HER2-positive breast cancer

Krop, I

Trastuzumab deruxtecan vs physician's choice in patients with HER2+ unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine: primary results of the randomized phase 3 study DESTINY-Breast02

Presentation #GS2-01

Oral Presentation - General Session 2

7 December 2022

09:00 - 09:15 CT

15:00 - 15:15 GMT

Hurvitz, SA

Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: Updated survival results of the randomized, phase 3 study DESTINY-Breast03

Presentation #GS2-02

Oral Presentation - General Session 2

7 December 2022

09:15 - 09:30 CT

15:15 - 15:30 GMT

Takashi, Y

Trastuzumab deruxtecan for the treatment of patients with HER2-positive breast cancer with brain and/or leptomeningeal metastases: A multicenter retrospective study (ROSET-BM study)

Presentation #PD7-01

Spotlight Poster Discussion 7

7 December 2022

17:00 CT

23:00 GMT

Hamilton, EP

Dose-expansion study of Trastuzumab Deruxtecan as monotherapy or combined with Pertuzumab in patients With metastatic human epidermal growth factor receptor 2-positive (HER2+) breast cancer in DESTINY-Breast07 (DB-07)

Presentation #PD18-11

Spotlight Poster Discussion 18

9 December 2022

07:00 CT

13:00 GMT

Varghese, D

A real-world evidence study of treatment patterns in patients with HER2-positive metastatic breast cancer who have received at least 2-lines of therapy

Presentation #P1-11-19

Poster Session 1

6 December 2022

17:00 CT

23:00 GMT

Lam, C

Treatment patterns and outcomes among patients with HER2-postive metastatic breast cancer in the United States

Presentation #P4-03-34

Poster Session 4

8 December 2022

07:00 CT

13:00 GMT

Henderson, M

Adverse events (AEs) in phase III clinical trials of patients with human epidermal growth factor receptor-2 positive (HER2+) breast cancer (BC): a meta-analysis

Presentation #P4-07-53

Poster Session 4

8 December 2022

07:00 CT

13:00 GMT

Lin, NU

Open-label, phase 3b/4 study of trastuzumab deruxtecan (T-DXd) in patients with or without baseline brain metastasis with advanced/metastatic human epidermal growth factor receptor 2-positive breast cancer: DESTINY-Breast12

Presentation #OT2-16-02

Ongoing Trials Poster Session 2

7 December 2022

17:00 CT

23:00 GMT

HER2-low breast cancer

Prat, A

Determination of HER2-low status in tumors of patients with unresectable and/or metastatic breast cancer in DESTINY-Breast04

Presentation #HER2-18

HER2 Low: A Separate Entity Special Poster Session

7 December 2022

09:45 - 11:00 CT

15:45 - 17:00 GMT

Viale, G

Retrospective Study to Estimate the Prevalence and Describe the Clinicopathological Characteristics, Treatment Patterns, and Outcomes of HER2-Low Breast Cancer

Presentation #HER2-15

HER2 Low: A Separate Entity Special Poster Session

7 December 2022

09:45 - 11:00 CT

15:45 - 17:00 GMT

Rüschoff, J

Proficiency assessment of HER2-low breast cancer scoring with the Ventana PATHWAY 4B5 and Dako HercepTest HER2 assays and the impact of pathologist training

Presentation #HER2-13

HER2 Low: A Separate Entity Special Poster Session

7 December 2022

09:45 - 11:00 CT

15:45 - 17:00 GMT

Schmid, P

Trastuzumab deruxtecan (T-DXd) + durvalumab (D) as first-line (1L) treatment for unresectable locally advanced/metastatic hormone receptor-negative (HR-), HER2-low breast cancer: updated results from BEGONIA, a phase 1b/2 study

Presentation #PD11-08

Spotlight Poster Discussion 11

8 December 2022

07:00 CT

13:00 GMT

Perez-García, JM

Trastuzumab Deruxtecan in patients with Unstable Central Nervous System Involvement from HER2-Low Advanced Breast Cancer: The DEBBRAH Trial

Presentation #PD7-02

Spotlight Poster Discussion 7

7 December 2022

17:00 CT

23:00 GMT

Harbeck, N

Trastuzumab deruxtecan vs treatment of physician's choice in patients with HER2-low unresectable and/or metastatic breast cancer: Subgroup analyses from DESTINY-Breast04

Presentation #P1-11-01

Poster Session 1

6 December 2022

17:00 CT

23:00 GMT

Spitzmüller, A

Computational pathology based HER2 expression quantification in HER2-low breast cancer

Presentation #P6-04-03

Poster Session 6

9 December 2022

07:00 CT

13:00 GMT

Tsirka, A

High Intra- and Inter-block concordance of HER2 immunohistochemistry (IHC) scores across breast cancer samples and impact of decalcification procedures

Presentation #P6-04-17

Poster Session 6

9 December 2022

07:00 CT

13:00 GMT

Globerson, Y

A fully automatic artificial intelligence system for accurate and reproducible HER2 IHC scoring in breast cancer

Presentation #P6-04-05

Poster Session 6

9 December 2022

07:00 CT

13:00 GMT

Kapil, A

ART: Automated Region segmentation of Tumor on HER2-stained breast cancer tissue

Presentation #P6-04-16

Poster Session 6

9 December 2022

07:00 CT

13:00 GMT HR-positive breast cancer

Hurvitz, SA

TRIO-US B-12 TALENT: Neoadjuvant trastuzumab deruxtecan with or without anastrozole for HER2-low, HR+ early stage breast cancer

Presentation #GS2-03

Oral Presentation - General Session 2

7 December 2022

09:30 - 09:45 CT

15:30 - 15:45 GMT

Oliveira, M

Camizestrant, a next generation oral SERD vs fulvestrant in post-menopausal women with advanced ER-positive HER2-negative breast cancer: Results of the randomized, multi-dose Phase 2 SERENA-2 trial

Presentation #GS3-02

Oral Presentation - General Session 3

8 December 2022

08:45 - 09:00 CT

14:45 - 15:00 GMT

Turner, NC

Capivasertib and fulvestrant for patients with aromatase inhibitor-resistant hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: results from the Phase III CAPItello-291 trial

Presentation #GS3-04

Oral Presentation - General Session 3

8 December 2022

09:15 - 09:30 CT

15:15 - 15:30 GMT

Meric-Bernstam, F

Phase 1 TROPION-PanTumor01 Study evaluating Datopotamab Deruxtecan (Dato-DXd) in unresectable or metastatic hormone receptor-positive/HER2-negative breast cancer (BC)

Presentation #PD13-08

Spotlight Poster Discussion 13

8 December 2022

17:00 CT

23:00 GMT

Carnevalli, L

Combination of the next generation oral SERD camizestrant (AZD9833) with CDK4/6 and mTOR/AKT inhibitors delivers robust efficacy in a broad range of ER+ breast tumors

Presentation #PD10-04

Spotlight Poster Discussion 10

8 December 2022

07:00 CT

13:00 GMT

Morrow, C

The next generation oral selective estrogen receptor degrader (SERD) camizestrant (AZD9833) is active against wild type and mutant estrogen receptor ?

Presentation #P3-07-13

Poster Session 3

7 December 2022

17:00 CT

23:00 GMT

Bardia, A

Datopotamab deruxtecan (Dato-DXd), a TROP2 antibody-drug conjugate,vs investigators' choice of chemotherapy in previously-treated, inoperable or metastatic HR+/HER2-breast cancer: TROPION-Breast01

Presentation #OT1-03-04

Ongoing Trials Poster Session 1

6 December 2022

17:00 CT

23:00 GMT

Turner, NC

SERENA-1: Updated analyses from a Phase 1 study of the next generation oral selective estrogen receptor degrader camizestrant (AZD9833) combined with abemaciclib, in women with ER-positive, HER2-negative advanced breast cancer

Presentation #OT2-02-01

Ongoing Trials Poster Session 2

7 December 2022

17:00 CT

23:00 GMT

TNBC and BRCA-mutated breast cancer

Schmid, P

Datopotamab deruxtecan (Dato-DXd) + durvalumab (D) as first-line (1L) treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): updated results from BEGONIA, a phase 1b/2 study

Presentation #PD11-09

Spotlight Poster Discussion 11

8 December 2022

07:00 CT

13:00 GMT

Bardia, A

Datopotamab Deruxtecan (Dato-DXd) in advanced triple-negative breast cancer (TNBC): Updated results from the Phase 1 TROPION-PanTumor01 Study

Presentation #P6-10-03

Poster Session 6

9 December 2022

07:00 CT

13:00 GMT

Copson, ER

Expert consensus on the definition of high risk of recurrence in HER2-negative eBC: a modified Delphi panel

Presentation #P3-05-39

Poster Session 3

7 December 2022

17:00 CT

23:00 GMT

Dent, R

TROPION-Breast02: Phase 3, open-label, randomized study of first-line datopotamab deruxtecan versus chemotherapy in patients with locally recurrent inoperable or metastatic TNBC who are not candidates for anti-PD-(L)1 therapy

Presentation #OT1-03-05

Ongoing Trials Poster Session 1

6 December 2022

17:00 CT

23:00 GMT

Balmaña, J

OlympiaN: a phase 2, multicenter, open-label study to assess the efficacy and safety of neoadjuvant olaparib monotherapy and olaparib plus durvalumab in patients with BRCA mutations and early-stage HER2-negative breast cancer

Presentation #OT2-18-02

Ongoing Trials Poster Session 2

7 December 2022

17:00 CT

23:00 GMT

Notes

AstraZeneca in breast cancer

Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need - with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment.

With Enhertu (trastuzumab deruxtecan), a HER2-directed ADC, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive and HER2-low metastatic breast cancer and are exploring its potential in earlier lines of treatment and in new breast cancer settings.

In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and aims to reshape the HR-positive space with ngSERD and potential new medicine camizestrant as well as a potential first-in-class AKT kinase inhibitor, capivasertib. AstraZeneca is also collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan, in this setting.

PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in metastatic breast cancer patients with an inherited BRCA mutation and are exploring new opportunities to treat these patients earlier in their disease.

To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is testing immunotherapy Imfinzi (durvalumab) in combination with other oncology medicines, including Lynparza and Enhertu, evaluating the potential of capivasertib in combination with chemotherapy, and datopotamab deruxtecan.

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

.

(C) 2022 M2 COMMUNICATIONS, source M2 PressWIRE

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Financials (USD)
Sales 2022 44 436 M - -
Net income 2022 4 125 M - -
Net Debt 2022 24 374 M - -
P/E ratio 2022 48,3x
Yield 2022 2,35%
Capitalization 195 B 195 B -
EV / Sales 2022 4,94x
EV / Sales 2023 4,65x
Nbr of Employees 83 100
Free-Float 96,4%
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Pascal Soriot Chief Executive Officer & Executive Director
Aradhana Sarin Chief Financial Officer & Executive Director
Leif Valdemar Johansson Non-Executive Chairman
Menelas NICOLAS Pangalos EVP-Biopharmaceuticals Research & Development
Pam P. Cheng Executive VP-Operations & Information Technology
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