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是一项全球货币III期、随机、双盲研究，评估了tiragolumab与Tecentriq相比于单独使用Tecentriq在534名PD-L1高表达的未经治疗的局部晚期不可切除或转移性NSCLC患者中的疗效。患者被1:1随机分组，接受tiragolumab加Tecentriq或安慰剂加Tecentriq，直至疾病进展、临床益处的丧失或不能忍受的毒性。该研究在最终分析时未达到总生存期的主要终点。观察到的整体安全性概况在更长时间的随访中保持一致，没有发现新的安全信号。详细数据将在2025年的医学会议上提交。
