• The SKYSCRAPER-01 study evaluating tiragolumab more Tecentriq did not achieve its primary endpoint of progression-free survival
  • The other primary endpoint of overall survival was immature and the study will continue until the next scheduled analysis
  • the tiragolumab development program continues as expected in non-small cell lung cancer and other cancer types

Basel, May 11, 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the results of its Phase III study SKYSCRAPER-01, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq® (atezolizumab ) compared to Tecentriq alone as first-line (first-line) therapy for people with locally advanced or metastatic PD-L1 elevated non-small cell lung cancer (NSCLC). The study did not achieve its co-primary endpoint of progression-free survival. At this first analysis, the other co-primary endpoint of overall survival (OS) was immature, and the study will continue until the next scheduled analysis. Numerical improvement was observed in both co-primary endpoints. The data suggest that tiragolumab plus Tecentriq was well tolerated and no new safety signals were identified with the addition of tiragolumab. Further analyzes of these results are ongoing and the data will be presented at an upcoming medical meeting.

“Although these results are not what we were hoping for in our first analysis, we look forward to seeing mature overall survival for this study to determine next steps,” said Levi Garraway, MD, Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We continue to believe that TIGIT may have a role in the treatment of cancer and we will share additional results from our tiragolumab program as they become available. »

The tiragolumab program continues to explore advances in multiple clinical trials to build on Tecentriq, expand into early stages of the disease, and seek to provide new treatment options for advanced and difficult-to-treat cancers with medical need unsatisfied high.

About the SKYSCRAPER-01 study
SKYSCRAPER-01 is a global, phase III, randomized, double-blind study evaluating tiragolumab plus Tecentriq® (atezolizumab) versus Tecentriq alone in 534 patients with first-line locally advanced non-small cell lung cancer , unresectable or metastatic. Patients were randomized 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq until disease progression, loss of clinical benefit, or unacceptable toxicity. The co-primary endpoints are overall survival and progression-free survival.

On tiragolumab
Tiragolumab is an investigational new immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel immune checkpoint inhibitor that suppresses the immune response to cancer.1 Based on preclinical research, tiragolumab is considered an immune enhancer along with other cancer immunotherapies such as Tecentriq® (atezolizumab).2 The TIGIT pathway is distinct but complementary to the PD-L1/PD-1 pathway. Double blocking with tiragolumab and Tecentriq can help overcome immune suppression and restore immune response.1

On Tecentriq® (atezolizumab)
Tecentriq is an approved cancer immunotherapy for some of the most aggressive and difficult to treat forms of cancer. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma. Tecentriq is also approved in the US, EU and countries around the world, alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer, metastatic triple cancer PD-L1 positive negative breast cancer and advanced melanoma carrying a BRAF V600 mutation.

Tecentriq is a monoclonal antibody designed to bind to a protein called programmed death ligand-1 (PD-L1), which is expressed on tumor cells and tumour-infiltrating immune cells, blocking its interactions with PD-1 receptors and B7.1. By inhibiting PD-L1, Tecentriq can activate T cell activation. Tecentriq is a cancer immunotherapy that has the potential to be used as a fundamental combination partner with other immunotherapies, targeted therapies and various chemotherapies for a wide range of cancers. In addition to intravenous infusion, the Tecentriq formulation is also being studied as a subcutaneous injection to hopefully provide a faster and more convenient option for cancer patients.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded drugs, Roche has become the world’s largest biotechnology company and the world leader in in vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics to improve and save the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform the way healthcare is delivered to have an even greater impact. To provide the best care for each person, we partner with many stakeholders and combine our strengths in diagnostics and pharmacy with insights from clinical practice.

In recognition of our efforts to pursue a long-term perspective in everything we do, Roche has been named one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indexes for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare with local partners in all the countries where we work.

Genentech, in the United States, is a full member of the Roche group. Roche is the majority shareholder of Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this press release are protected by law.

References
[1] Cho BC, Rodriguez-Abreu D, et al. Updated analysis and patient-reported results from CITYSCAPE: a randomized, double-blind, Phase II study of the anti-TIGIT antibody tiragolumab + atezolizumab versus placebo + atezolizumab as first-line treatment for NSCLC PD-L1+. Presented at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2021; December 8-11, 2021. Abstract #LBA2.
[2] Johnston RJ, Comps-Agrar L. Cancer Cell. 2014;26:923-937.

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