Roche's Genentech Provides Update On SKYSCRAPER-01 Phase III Study In PD-L1-High NSCLC Patients
Roche's Genentech Provides Update On SKYSCRAPER-01 Phase III Study In PD-L1-High NSCLC Patients
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.
SKYSCRAPER-01是一項全球貨幣III期、隨機、雙盲研究，評估了tiragolumab與Tecentriq相比於單獨使用Tecentriq在534名PD-L1高表達的未經治療的局部晚期不可切除或轉移性NSCLC患者中的療效。患者被1:1隨機分組，接受tiragolumab加Tecentriq或安慰劑加Tecentriq，直至疾病進展、臨床益處的喪失或不能忍受的毒性。該研究在最終分析時未達到總生存期的主要終點。觀察到的整體安全性概況在更長時間的隨訪中保持一致，沒有發現新的安全信號。詳細數據將在2025年的醫學會議上提交。
