-- Tiragolumab is the first anti-TIGIT therapy to be granted Breakthrough 
      Therapy Designation (BTD) and marks the 37th BTD for Roche's portfolio of 
      medicines 
 
   -- BTD is based on the randomised phase II CITYSCAPE study that showed 
      encouraging efficacy and safety with tiragolumab plus Tecentriq 
      (atezolizumab) in people with PD-L1-positive metastatic non-small cell 
      lung cancer 
 
   -- Broad tiragolumab development programme is ongoing across various 
      settings in different tumour types, including lung, oesophageal and 
      cervical cancers 
 
 
   Basel, 5 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today 
announced that tiragolumab, a novel cancer immunotherapy designed to 
bind to TIGIT, has been granted Breakthrough Therapy Designation (BTD) 
by the US Food and Drug Administration (FDA), in combination with 
Tecentriq(R) (atezolizumab) for the first-line treatment of people with 
metastatic non-small cell lung cancer (NSCLC) whose tumours have high 
PD-L1 expression with no EGFR or ALK genomic tumour aberrations. 
Tiragolumab is the first anti-TIGIT molecule to be granted BTD from the 
FDA, and the designation is based on randomised data from the phase II 
CITYSCAPE trial. CITYSCAPE provides the first evidence that targeting 
both immune inhibitory receptors, TIGIT and PD-L1, may enhance 
anti-tumour activity by potentially amplifying the immune response.(1) 
 
   "We have been researching TIGIT as a novel cancer immunotherapy target 
for almost ten years and we are pleased that the FDA has acknowledged 
the potential of tiragolumab to substantially improve outcomes for 
people with certain types of lung cancer," said Levi Garraway, M.D., 
Ph.D., Roche's Chief Medical Officer and Head of Global Product 
Development. "We look forward to advancing our tiragolumab development 
programme, which includes chemotherapy-free combinations and trials in 
early stages of disease across multiple cancer types with high unmet 
need." 
 
   BTD is designed to accelerate the development and review of medicines 
intended to treat serious or life-threatening conditions, with 
preliminary evidence that indicates they may demonstrate a substantial 
improvement over existing therapies. This marks the 37th BTD for Roche's 
portfolio of medicines. 
 
   Tiragolumab in combination with Tecentriq has so far shown encouraging 
efficacy and safety in PD-L1-positive metastatic NSCLC based on data 
from the phase II CITYSCAPE trial, the first randomised study in the 
anti-TIGIT field.(1) Full results from CITYSCAPE, presented at the 
American Society of Clinical Oncology 2020 Virtual Scientific Program, 
showed that at an average of 10.9 months follow-up, the combination 
showed an improvement in the overall response rate (ORR; 37% vs. 21% 
with Tecentriq alone) and a 42% reduction in the risk of disease 
worsening or death (progression free survival; PFS) compared with 
Tecentriq alone.(1) An exploratory analysis in people with high levels 
of PD-L1 (tumour proportion score; TPS >= 50%) showed a clinically 
meaningful ORR vs. Tecentriq alone (66% vs. 24%) and median PFS was not 
reached (vs. 4.11 months with Tecentriq alone; HR=0.30, 95% CI: 
0.15--0.61).(1) The data suggest that tiragolumab plus Tecentriq was 
generally well-tolerated, showing similar rates of all Grade 3 or more 
all-cause adverse events when combining the two immunotherapies compared 
with Tecentriq alone (48% vs. 44%).(1) 
 
   Roche is investigating the potential of tiragolumab in a broad 
development programme that builds on the benefit observed with Tecentriq 
while expanding into earlier stages of disease and new areas of unmet 
need. This includes randomised trials in metastatic NSCLC (SKYSCRAPER-01 
and SKYSCRAPER-06) and small cell lung cancer (SKYSCRAPER-02), as well 
as exploration of tiragolumab in earlier stages, including stage III 
NSCLC (SKYSCRAPER-03) and locally advanced oesophageal cancer 
(SKYSCRAPER-07). Tiragolumab is also being investigated in metastatic 
oesophageal squamous cancer (SKYSCRAPER-08) and cervical cancer 
(SKYSCRAPER-04), with early trials in other tumour types. 
 
   Biomarker analyses from the CITYSCAPE study will be presented at the 
IASLC 2020 World Conference on Lung Cancer hosted by the International 
Association for the Study of Lung Cancer, taking place from 28-31 
January 2021: Efficacy of Tiragolumab + Atezolizumab in PD-L1 IHC and 
TIGIT Subgroups in the Phase II CITYSCAPE Study in First-Line NSCLC. 
 
   Dual blockade of the TIGIT and PD-L1 pathways 
 
   TIGIT and PD-L1 are proteins that play a role in suppression of the 
immune system.(2) Blocking both pathways simultaneously with tiragolumab 
and Tecentriq(R) (atezolizumab) has the potential to increase 
anti-tumour activity by enhancing the body's immune response to cancer 
cells.(1) Targeting multiple immune pathways in this way has the 
potential to build upon previous advances in cancer immunotherapy, 
expand into earlier stages of disease and provide new treatment options 
in areas of high unmet need. 
 
   About the CITYSCAPE study(1) 
 
   CITYSCAPE is a global phase II, randomised and blinded study evaluating 
tiragolumab plus Tecentriq(R) (atezolizumab) compared with Tecentriq 
alone in 135 patients with first-line PD-L1-positive, locally advanced 
unresectable or metastatic non-small cell lung cancer. Patients were 
randomised 1:1 to receive either tiragolumab plus Tecentriq or placebo 
plus Tecentriq, until progressive disease or loss of clinical benefit. 
Co-primary endpoints are overall response rate and progression-free 
survival. Secondary endpoints include safety and overall survival. 
 
   About tiragolumab 
 
   Tiragolumab is a monoclonal antibody designed to bind with TIGIT, a 
protein receptor on immune cells.(2,3) Tiragolumab works as an immune 
amplifier, by potentially enhancing the body's immune response.(1) By 
binding to TIGIT, tiragolumab blocks its interaction with a protein 
called poliovirus receptor (PVR, or CD155) that can suppress the body's 
immune response.(4) Blockade of TIGIT and PD-L1 may synergistically 
enable the re-activation of T cells and enhance NK cell anti-tumour 
activity.(2,5,6) 
 
   About Tecentriq(R) (atezolizumab) 
 
   Tecentriq is a monoclonal antibody designed to bind with a protein 
called PD-L1, which is expressed on tumour cells and tumour-infiltrating 
immune cells, blocking its interactions with both PD-1 and B7.1 
receptors. By inhibiting PD-L1, Tecentriq may enable the activation of 
T-cells. Tecentriq is a cancer immunotherapy that has the potential to 
be used as a foundational combination partner with other immunotherapies, 
targeted medicines and various chemotherapies across a broad range of 
cancers. The development of Tecentriq and its clinical programme is 
based on our greater understanding of how the immune system interacts 
with tumours and how harnessing a person's immune system combats cancer 
more effectively. 
 
   Tecentriq is approved in the US, EU and countries around the world, 
either alone or in combination with targeted therapies and/or 
chemotherapies in various forms of non-small cell lung cancer, small 
cell lung cancer, certain types of metastatic urothelial cancer, in 
PD-L1-positive metastatic triple-negative breast cancer and for 
hepatocellular carcinoma. In the US, Tecentriq is also approved in 
combination with Cotellic(R) (cobimetinib) and Zelboraf(R) (vemurafenib) 
for the treatment of people with BRAF V600 mutation-positive advanced 
melanoma. 
 
   About Roche in cancer immunotherapy 
 
   Roche's rigorous pursuit of groundbreaking science has contributed to 
major therapeutic and diagnostic advances in oncology over the last 50 
years, and today, realising the full potential of cancer immunotherapy 
is a major area of focus. With over 20 molecules in development, Roche 
is investigating the potential benefits of immunotherapy alone, and in 
combination with chemotherapy, targeted therapies or other 
immunotherapies with the goal of providing each person with a treatment 
tailored to harness their own unique immune system to attack their 
cancer. Our scientific expertise, coupled with innovative pipeline and 
extensive partnerships, gives us the confidence to continue pursuing the 
vision of finding a cure for cancer by ensuring the right treatment for 
the right patient at the right time. 
 
   In addition to Roche's approved PD-L1 checkpoint inhibitor, Tecentriq(R) 
(atezolizumab), Roche's broad cancer immunotherapy pipeline includes 
other checkpoint inhibitors, such as tiragolumab, a novel cancer 
immunotherapy designed to bind to TIGIT, individualised neoantigen 
therapies and T-cell bispecific antibodies. To learn more about Roche's 
scientific-led approach to cancer immunotherapy, please follow this 
link: 
 
   https://www.globenewswire.com/Tracker?data=7hOxLtK9c04aSO-rPGYfXsdZwYUT_t5qscVpqJowKK3oMb5clGIf0k8H6rxMnJvPKDMne_wEHMs35jSW7D5zXYZTiBMWHQAkKM678JKAqBO2E5ilrzhPtZGSKBmHn61W8c0l818YEwfNd6_FlxCmQi_iKlEIqn3RebyWqWOuxZqHJrVLLltkTG52QrhZq3xsPWIvHkOen5WR5ju0OUpGSFciLcjOKqIu5oE8JKzm_2N8CcAQUag0Fpu-J2Q_gnTcvQm3GPlk3807qk2pZ_45p6phoHiSOArAEiPowus8lO3OGIUt9s85TAP_hdBJmcrk 
http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htm 
 
 
 
 
   About Roche 
 
   Roche is a global pioneer in pharmaceuticals and diagnostics focused on 
advancing science to improve people's lives. The combined strengths of 
pharmaceuticals and diagnostics under one roof have made Roche the 
leader in personalised healthcare -- a strategy that aims to fit the 
right treatment to each patient in the best way possible. 
 
 
 
   Roche is the world's largest biotech company, with truly differentiated 
medicines in oncology, immunology, infectious diseases, ophthalmology 
and diseases of the central nervous system. Roche is also the world 
leader in in vitro diagnostics and tissue-based cancer diagnostics, and 
a frontrunner in diabetes management. 
 
 
 
   Founded in 1896, Roche continues to search for better ways to prevent,

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January 05, 2021 01:00 ET (06:00 GMT)