Phase II/III SKYSCRAPER-06 study evaluating tiragolumab plus Tecentriq and chemotherapy did not meet primary endpoints

Overview

Genentech, a member of the Roche Group, announced that the Phase II/III SKYSCRAPER-06 study evaluating tiragolumab plus Tecentriq and chemotherapy did not meet the primary endpoints of progression-free survival and overall survival for people with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer.

Study Details

The study was a randomized, placebo-controlled and double-blinded study evaluating tiragolumab plus Tecentriq and chemotherapy as an initial (first-line) treatment versus pembrolizumab and chemotherapy in 542 people with non-squamous non-small cell lung cancer. The primary endpoints were overall survival (OS) and progression-free survival (PFS).

Results

The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy in both PFS and OS compared to the comparator arm in the intent-to-treat population, which includes Phase II and Phase III cohorts. The overall safety profile remains consistent with the safety profile previously observed for the combination of tiragolumab plus Tecentriq and chemotherapy, and no new or unexpected findings were identified.

Implications

The results are disappointing as it was hoped that this combination might yield improved outcomes for people living with metastatic non-squamous lung cancer. Based on these results, patients and investigators will be unblinded and the study will be halted. A communication will be sent to the investigators and results will be shared with health authorities and subsequently presented at an upcoming medical meeting.

About Tiragolumab and Tecentriq

Tiragolumab is an investigational novel immune checkpoint inhibitor with an intact Fc region that selectively binds to TIGIT, a novel inhibitory immune checkpoint which suppresses the immune response to cancer. 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.

Side Effects of Tecentriq

Tecentriq can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. Common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include infusion reactions, complications in people who have received a bone marrow transplant, and fertility problems in females.

Conclusion

While the results of the SKYSCRAPER-06 study are disappointing, ongoing Phase III studies are investigating treatment settings and indications distinct from this study. These studies will continue to investigate the use of tiragolumab and Tecentriq in the treatment of non-squamous non-small cell lung cancer.

Originally Post From https://www.gene.com/media/press-releases/15029/2024-07-03/genentech-provides-update-on-phase-iiiii

Read more about this topic at
Lung cancer – Diagnosis and treatment
Lung Cancer Treatment