Roche reports SKYSCRAPER-01 study misses primary endpoint

Genentech, a member of the Roche (RHHBY), reported an update on the Phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer, or NSCLC. SKYSCRAPER-01 is a global Phase III, randomized, double-blinded study evaluating tiragolumab plus Tecentriq compared to Tecentriq alone in 534 patients with PD-L1-high previously untreated, locally advanced unresectable or metastatic NSCLC. Patients were randomized 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until disease progression, loss of clinical benefit, or unacceptable toxicity. The study did not reach the primary endpoint of overall survival at the final analysis. The overall safety profile observed remained consistent with longer follow-up, and no new safety signals were identified. The detailed data will be presented at a medical meeting in 2025.