Phase 3 trial of regimen for small cell lung cancer misses co-primary endpoint
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A randomized phase 3 trial designed to assess the addition of tiragolumab to atezolizumab and chemotherapy as first-line treatment for extensive-stage small cell lung cancer failed to meet its co-primary endpoint of PFS.
Tiragolumab (Genentech) is a novel immune checkpoint inhibitor with an intact Fc region. The agent selectively binds to TIGIT, a novel inhibitory immune checkpoint that suppresses the immune response to cancer, according to a Genentech-issued press release.
Atezolizumab (Tecentriq, Genentech) is an anti-PD-L1 monoclonal antibody.
The global SKYSCRAPER-02 trial included 490 patients with extensive-stage small cell lung cancer. Researchers randomly assigned patients to atezolizumab and chemotherapy — carboplatin and etoposide — with or without tiragolumab.
Co-primary endpoints included PFS and OS among all randomly assigned patients whose cancer had not metastasized to the brain. Key secondary endpoints included OS and PFS among all randomly assigned patients, as well as safety.
The study did not meet its PFS co-primary endpoint. Interim analysis results showed the study did not meet its OS co-primary endpoint, and researchers indicated the difference between treatment groups likely will not reach statistical significance at the planned final analysis.
The combination of tiragolumab, atezolizumab and chemotherapy appeared well-tolerated, and investigators reported no new safety signals.
Complete results of SKYSCRAPER-02 will be submitted for presentation at a medical meeting.
“[This] outcome is disappointing, as we had hoped to continue building on the advances of Tecentriq in extensive-stage small cell lung cancer, which remains difficult to treat,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Genentech, said in the release.
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