Genentech Updates on Phase III SKYSCRAPER-01 Study of Tiragolumab with Tecentriq

South San Francisco, CA -- November 25, 2024 -- Genentech, a Roche Group member, has announced an update on its Phase III SKYSCRAPER-01 study. This study is focused on evaluating the combination of tiragolumab and Tecentriq® (atezolizumab) compared to Tecentriq alone in patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC).

The SKYSCRAPER-01 study is a comprehensive Phase III, randomized, double-blinded clinical trial involving 534 patients. These participants, who have previously untreated and advanced forms of NSCLC, were randomly assigned in a 1:1 ratio to receive either tiragolumab and Tecentriq or a placebo along with Tecentriq. The treatment was to continue until disease progression, loss of clinical benefit, or the onset of unacceptable toxicity.

At the final analysis, the study did not achieve its primary goal of improving overall survival rates. However, the safety profile observed in the study remained largely consistent with longer follow-up periods, and no new safety concerns were identified. Genentech plans to present detailed data from the study at a medical conference scheduled for 2025.

Genentech is committed to continuously reviewing and adjusting its study programs to support ongoing research. The company intends to apply this approach to the current program, with additional data expected from other Phase III studies across various settings or tumor types next year.

Tiragolumab is an investigational immune checkpoint inhibitor. It works by selectively binding to TIGIT, a new inhibitory checkpoint that suppresses the immune response to cancer. This investigational drug aims to bolster the body's immune system in fighting cancer cells.

Tecentriq® (atezolizumab) is a monoclonal antibody designed to bind with the PD-L1 protein found on tumor cells and tumor-infiltrating immune cells. By blocking PD-L1 interactions with PD-1 and B7.1 receptors, Tecentriq may enable the reactivation of T cells. However, Tecentriq may also affect normal cells.

Tecentriq is prescribed for adults with non-small cell lung cancer (NSCLC). It is not yet established whether Tecentriq is safe and effective for children with NSCLC. The most important information about Tecentriq includes its potential to cause the immune system to attack normal organs and tissues, which can lead to severe or life-threatening complications. These immune system issues can occur anytime during or after treatment.

Patients are advised to contact their healthcare provider immediately if they experience any new or worsening symptoms, such as lung, intestinal, liver, hormone gland, kidney, or skin problems. There is also a risk of complications, including graft-versus-host disease (GVHD), for those who have received a bone marrow or stem cell transplant. Healthcare providers will monitor patients closely for these issues and may administer treatments like corticosteroids or hormone replacements if necessary. Severe side effects may necessitate a delay or discontinuation of Tecentriq treatment.

Before starting Tecentriq, patients should inform their healthcare provider about their complete medical history and any medications they are currently taking. Common side effects of Tecentriq, whether used alone or with other anti-cancer medicines, include various adverse reactions. Tecentriq may also cause fertility problems in females.

Genentech, a pioneering biotechnology company headquartered in South San Francisco, California, specializes in the discovery, development, manufacturing, and commercialization of medicines for serious and life-threatening conditions. The company is part of the Roche Group and has been operational for over four decades.