Study Results Show Genentech’s Tiragolumab Did Not Meet Primary Endpoints

The SKYSCRAPER-01 trial evaluating the drug plus Tecentriq demonstrates that it did not meet its co-primary endpoint of progression-free survival.

Genentech’s phase 3 SKYSCRAPER-01 study, which evaluated an investigational anti-TIGIT immunotherapy, tiragolumab, with atezolizumab (Tecentriq) compared with atezolizumab alone, as a first-line treatment for individuals with PD-L1-high locally advanced or metastatic non–small cell lung cancer (NSCLC), did not meet its co-primary endpoint of progression-free survival, the company said in a statement.1

The first analysis showed that the other co-primary endpoint of overall survival was immature, and the study will continue until the next planned analysis.1

“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,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech, said in a statement. “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.”1

A numerical improvement was observed in both co-primary endpoints, and data suggest that tiragolumab with atezolizumab was well tolerated.1

No new safety signals were identified when adding tiragolumab. The most common adverse events (AEs) for atezolizumab as a monotherapy were cough, a decreased appetite, feeling tired or weak, nausea, and shortness of breath.1

Other AEs included constipation, diarrhea, decreased appetite feeling tired or weak, hair loss, and nausea.1

The SKYSCRAPER-01 phase 3 trial is a double-blind randomized study. Investigators included 534 individuals with PD-L1-high locally advanced, metastatic, or unresectable NSCLC. The individuals received a first-line treatment of either tiragolumab with atezolizumab or atezolizumab with a placebo until disease progression, loss of clinical benefit, or unacceptable toxicity.1

Further analyses of the results are ongoing, and data will be presented at an upcoming medical meeting.1

Tiragolumab is an investigational novel immune checkpoint inhibitor with an intact Fc region and is thought to work as an immune amplifier with other cancer immunotherapies, based on preclinical research.1

Atezolizumab is a monoclonal antibody designed to bind with a protein called PD-L1 and is indicated as a monotherapy and a combination therapy for individuals with NSCLC. It can also be used when lung cancer has grown or spread and patients tried chemotherapy that contains platinum, and it did not work or is no longer working.1

The tiragolumab program continues to explore advances in multiple clinical trials with the goal of providing new treatment options in advanced and difficult-to-treat cancers, as well as expanding into earlier stages of disease.1

Lung cancer is the second-most-common cancer, with NSCLC accounting for approximately 84% of the cases, according to the American Cancer Society.2

Lung cancer mainly occurs in individuals aged 65 years or older, with a very small number diagnosed younger than aged 45 years.2

Reference

1. Genentech reports interim results for phase III SKYSCRAPER-01 study in PD-L1-high metastatic non–small cell lung cancer. Genentech. News release. May 10, 2022. Accessed May 11, 2022. https://www.gene.com/media/press-releases/14951/2022-05-10/genentech-reports-interim-results-for-ph

2. Key statistics for lung cancer. American Cancer Society. Updated February 14, 2022. Accessed May 11, 2022. https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html