Press Release : Roche provides update on Tecentriq US indication in prior-platinum treated metastatic bladder cancer

   Basel, 8 March 2021 -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today 
announced that the company is voluntarily withdrawing the US indication 
for Tecentriq(R) (atezolizumab) in prior-platinum treated metastatic 
urothelial carcinoma (mUC, bladder cancer). This decision was made in 
consultation with the US Food and Drug Administration (FDA) as part of 
an industry-wide review of accelerated approvals with confirmatory 
trials that have not met their primary endpoint(s) and have yet to gain 
regular approvals. Roche will work with the FDA over the coming weeks to 
complete the withdrawal process. This decision does not affect other 
approved indications for Tecentriq. Roche is notifying healthcare 
professionals about this withdrawal. Patients being treated with 
Tecentriq for prior-platinum treated mUC should discuss their care with 
their healthcare provider. 
 
 
 
   "The Accelerated Approval Program allows people with difficult-to-treat 
cancers to receive certain new therapies earlier," said Levi Garraway, 
M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product 
Development. "While the withdrawal of Tecentriq for prior-platinum 
treated bladder cancer is disappointing, Tecentriq continues to 
demonstrate benefits across multiple cancer types and therefore remains 
a meaningful treatment option for many patients." 
 
 
 
   The FDA's Accelerated Approval Program allows conditional approval of a 
medicine that fills an unmet medical need for a serious condition, with 
specific post marketing requirements (PMRs) to confirm the clinical 
benefit and convert to regular approval. 
 
 
 
   Tecentriq was granted accelerated approval in 2016 for the treatment of 
prior-platinum treated mUC based on the results from the IMvigor210 
study (Cohort 2). Continued approval for this indication was contingent 
upon the results of IMvigor211, the original PMR for the prior-platinum 
treated mUC indication. This study did not meet its primary endpoint of 
overall survival in the PD-L1 high patient population. Subsequently, the 
FDA designated the IMvigor130 study as the PMR which will still continue 
until the final analysis. However, as the treatment landscape in 
prior-platinum (second-line) mUC has rapidly evolved with the emergence 
of new treatment options, Roche is voluntarily withdrawing this 
indication in recognition of the principles of the Accelerated Approval 
Program. 
 
 
 
   About Tecentriq 
 
   Tecentriq is a monoclonal antibody designed to bind with a protein 
called Programmed Death Ligand-1 (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 mUC, in PD-L1-positive mTNBC 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=OKXV2tx5bLoIIuiDew0cOWAwymjMK2CbLnOVa2IyamynrnG-daSDUuHOg60BQTubAcOT0f_ZCdZSSBdMd7AQ3JszrjTOEx6MC8QxFjkrTOLv-pkZGsc1rtyceXA0Z0RLp1x6hGO5cJKTNyUaaa-lW6524NvWx2imA5yEmwy6cJCDTIwvxk3g05P7Evt1YjG8L4juCWphvAHo4JXu-DvvME81FPyObHYhjdcguJj2CxsNlkk3aFNGg_hi2ylH_SJS5RGRA0TYSl3VPx6NlcP3GkOsOdd3ZL2aKGq7YQo5xAmDiO9mXhiv2WLaJkxzpsr1 
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, 
diagnose and treat diseases and make a sustainable contribution to 
society. The company also aims to improve patient access to medical 
innovations by working with all relevant stakeholders. More than thirty 
medicines developed by Roche are included in the World Health 
Organization Model Lists of Essential Medicines, among them life-saving 
antibiotics, antimalarials and cancer medicines. Moreover, for the 
twelfth consecutive year, Roche has been recognised as one of the most 
sustainable companies in the Pharmaceuticals Industry by the Dow Jones 
Sustainability Indices (DJSI). 
 
 
 
   The Roche Group, headquartered in Basel, Switzerland, is active in over 
100 countries and in 2020 employed more than 100,000 people worldwide. 
In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 
58.3 billion. Genentech, in the United States, is a wholly owned member 
of the Roche Group. Roche is the majority shareholder in Chugai 
Pharmaceutical, Japan. For more information, please visit 
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www.roche.com. 
 
 
 
   All trademarks used or mentioned in this release are protected by law. 
 
 
 
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(END) Dow Jones Newswires

March 08, 2021 01:00 ET (06:00 GMT)