Genentech Reports Interim Results for Phase III SKYSCRAPER-01 Study in PD-L1-High Metastatic Non-Small Cell Lung Cancer

The SKYSCRAPER-01 study evaluating tiragolumab plus Tecentriq did not meet its co-primary endpoint of progression-free survival

The other co-primary endpoint of overall survival was immature and the study will continue until the next planned analysis

The tiragolumab development program continues as planned in non-small cell lung cancer and other cancer types

SOUTH SAN FRANCISCO, CA, USA I May 10, 2022 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from its Phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq ® (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC). The study did not meet 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 planned analysis. A numerical improvement was observed in both co-primary endpoints. Data suggest that tiragolumab plus Tecentriq was well-tolerated and no new safety signals were identified when adding tiragolumab. Further analyses of these results are ongoing and data will be presented at an upcoming medical meeting.

“While these results are not what we hoped for in our first analysis, we look forward to seeing mature overall survival for this study to determine next steps,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We continue to believe that TIGIT may have a role in cancer treatment and we will share additional results from our tiragolumab program as they emerge.”

The tiragolumab program continues to explore advances in multiple clinical trials, building on Tecentriq, with the goal of providing new treatment options in advanced and difficult-to-treat cancers as well as expanding into earlier stages of disease.

About the SKYSCRAPER-01 study
SKYSCRAPER-01 is a global Phase III, randomized double-blinded study evaluating tiragolumab plus Tecentriq® (atezolizumab) versus Tecentriq alone in 534 patients with first-line PD-L1-high locally advanced, unresectable or metastatic non-small cell lung cancer. 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. Co-primary endpoints are overall survival and progression-free survival.

About tiragolumab
Tiragolumab is an investigational novel immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory immune checkpoint, which suppresses the immune response to cancer. Based on preclinical research, tiragolumab is thought to work as an immune amplifier with other cancer immunotherapies such as Tecentriq ® (atezolizumab). The TIGIT pathway is distinct, but complementary to the PD-L1/PD-1 pathway. Dual blockade with tiragolumab and Tecentriq may help overcome immune suppression and restore the immune response.

About Tecentriq® (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq U.S. Indications
Tecentriq is a prescription medicine used to treat adults with:

A type of lung cancer called non-small cell lung cancer (NSCLC).

  • Tecentriq may be used alone as a treatment for their lung cancer:
    • to help prevent their lung cancer from coming back after their tumor(s) has been removed by surgery and they have received platinum-based chemotherapy, and
    • they have stage 2 to 3A NSCLC (patients should talk to their healthcare provider about what these stages mean), and
    • their cancer tests positive for “PD-L1”.
  • Tecentriq may be used alone as their first treatment when their lung cancer:
    • has spread or grown, and
    • their cancer tests positive for “high PD-L1”, and
    • their tumor does not have an abnormal “EGFR” or “ALK” gene
  • Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as their first treatment when their lung cancer:
    • has spread or grown, and
    • is a type called “non-squamous NSCLC,” and
    • their tumor does not have an abnormal “EGFR” or “ALK” gene
  • Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as their first treatment when their lung cancer:
    • has spread or grown, and
    • is a type called “non-squamous NSCLC,” and
    • their tumor does not have an abnormal “EGFR” or “ALK” gene
  • Tecentriq may also be used when their lung cancer:
    • has spread or grown, and
    • they have tried chemotherapy that contains platinum, and it did not work or is no longer working
    • if their tumor has an abnormal “EGFR” or “ALK” gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working

It is not known if Tecentriq is safe and effective in children.

Please see http://www.Tecentriq.comfor full Prescribing Information and additional Important Safety Information.

About Genentech in cancer immunotherapy
Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system.

In addition to Genentech’s approved PD-L1 checkpoint inhibitor, the company’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. For more information visit http://www.gene.com/cancer-immunotherapy.

About Genentech in lung cancer
Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have five approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

SOURCE: Genentech

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