SKYSCRAPER-03: a phase III study of tiragolumab plus atezolizumab versus durvalumab in locally advanced, unresectable, stage III NSCLC after platinum-based concurrent chemoradiation☆

초록

Background: SKYSCRAPER-03 (NCT04513925) was a phase III, open-label, randomized study that evaluated consolidation therapy with tiragolumab plus atezolizumab versus durvalumab in patients with locally advanced, unresectable, stage III, non-small-cell lung cancer (NSCLC) after platinum-based concurrent chemoradiation. Patients and methods: Eligible patients were randomly assigned (1 : 1) to receive either atezolizumab [1680 mg every 4 weeks (Q4W)] plus tiragolumab (840 mg Q4W) on day 1 of each cycle or durvalumab (10 mg/kg every 2 weeks or 1500 mg Q4W for those ≥30 kg body weight) on days 1 and 15 of each cycle for 13 × 28-day cycles. The primary endpoint was Independent Review Facility (IRF)-assessed progression-free survival (PFS) in patients with programmed death-ligand 1 (PD-L1)-positive (tumor cells ≥1%) NSCLC. Key secondary endpoints were overall survival (OS) and safety. Results: The PD-L1 all-comers population included 413 patients randomly assigned to tiragolumab plus atezolizumab and 416 to durvalumab; the PD-L1-positive population included 209 and 210 patients in each arm, respectively. After a median follow-up of 33.0 months, median IRF-assessed PFS in PD-L1-positive patients was 19.4 months with tiragolumab plus atezolizumab compared with 16.6 months with durvalumab [stratified hazard ratio (HR) 0.96, 95% confidence interval (CI) 0.75-1.23, P = 0.76]; median PFS in PD-L1 all-comers was 14.2 compared with 13.8 months, respectively (stratified HR 1.00, 95% CI 0.84-1.19). The median OS in PD-L1-positive patients was not estimable with tiragolumab plus atezolizumab compared with 54.8 months with durvalumab (stratified HR 0.99, 95% CI 0.73-1.34); in PD-L1 all-comers, the median OS was 45.6 compared with 45.8 months, respectively (stratified HR 0.98, 95% CI 0.80-1.20). The safety profile of the combination was consistent with prior observations and there were no new or unexpected findings. Conclusions: The primary endpoint of the SKYSCRAPER-03 study was not met. Tiragolumab plus atezolizumab was tolerated but did not offer additional benefit over durvalumab. © 2026 European Society for Medical Oncology. Published by Elsevier Ltd. All rights are reserved, including those for text and data mining, AI training, and similar technologies.

키워드