Phase 3 trial of combination for advanced lung cancer misses co-primary endpoint
Click Here to Manage Email Alerts
A randomized phase 3 trial designed to evaluate tiragolumab plus atezolizumab for certain patients with advanced lung cancer failed to meet its co-primary endpoint of PFS, topline data showed.
Data for the other co-primary endpoint of OS remained immature, and the study will continue until the next planned analysis.
Tiragolumab (Genentech/Roche) is an immunotherapy designed to bind to TIGIT, a protein receptor on immune cells. Atezolizumab (Tecentriq, Genentech/Roche) is an anti-PD-L1 therapy.
The global double-blind SKYSCRAPER-01 study included 534 patients with PD-L1-high locally advanced unresectable or metastatic non-small cell lung cancer. Researchers randomly assigned patients 1:1 to first-line treatment with the combination or atezolizumab alone.
Treatment continued until disease progression, loss of clinical benefit or unacceptable toxicity.
Researchers observed numerical improvements in both co-primary endpoints with the combination, but the differences did not reach statistical significance.
The combination appeared well-tolerated, and investigators observed no new safety signals with the addition of tiragolumab to atezolizumab, according to a Roche-issued press release.
“[Although] 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, Roche’s chief medical officer and head of global product development, said in the release. “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.”
Click Here to Manage Email Alerts