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 III 期、隨機、雙盲研究，對 534 名先前未經治療、局部晚期不可切除或轉移性非小細胞肺癌的患者，對比單獨使用 Tecentriq，評估了替拉古魯單抗與單獨使用 Tecentriq 的比較。患者按 1:1 的隨機分配，接受替拉古魯單抗加Tecentriq或安慰劑加Tecentriq，直到疾病進展、臨床益處喪失或毒性不可接受爲止。在最終分析中，該研究沒有達到總存活率的主要終點。在較長的隨訪時間內，觀察到的總體安全狀況保持一致，沒有發現新的安全信號。詳細數據將在2025年的醫學會議上公佈。
