Roche Provides Update on Phase III SKYSCRAPER-01 Study Results
Swiss pharma giant Roche has shared the results of its Phase III SKYSCRAPER-01 study, which evaluated 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 global, randomized, double-blind study included 534 patients who were assigned 1:1 to receive either tiragolumab plus Tecentriq or a placebo plus Tecentriq. Patients continued treatment until disease progression, loss of clinical benefit, or unacceptable toxicity. Despite high expectations, the study did not meet its primary endpoint of overall survival at the final analysis.
Safety data remained consistent with prior observations, and no new safety signals were identified during the extended follow-up. Roche announced that detailed results would be presented at a medical conference in 2025.
Tiragolumab, an investigational immune checkpoint inhibitor, targets TIGIT, a novel immune checkpoint that suppresses the body’s response to cancer. Tecentriq, a monoclonal antibody, works by blocking the interaction of PD-L1 with PD-1 and B7.1 receptors, potentially reactivating T cells to fight cancer.
Roche emphasized its commitment to refining its study programs, with further data from ongoing Phase III trials across different tumor types and treatment settings expected in 2025.
The SKYSCRAPER-01 study reflects Roche’s ongoing efforts to explore innovative approaches in immuno-oncology, despite this setback. The company remains focused on developing treatments to address unmet needs in cancer care.