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Five-Year Survival Outcomes With Atezolizumab After Chemotherapy in Resected Stage IB-IIIA Non-Small Cell Lung Cancer (IMpower010): An Open-Label, Randomized, Phase III Trial.

Five-Year Survival Outcomes With Atezolizumab After Chemotherapy in Resected Stage IB-IIIA Non-Small Cell Lung Cancer (IMpower010): An Open-Label, Randomized, Phase III Trial. Journal of clinical oncology : official journal of the American Society of Clinical Oncology Felip, E., Altorki, N., Zhou, C., Vallières, E., Csoszi, T., Vynnychenko, I. O., Goloborodko, O., Rittmeyer, A., Reck, M., Martinez-Marti, A., Kenmotsu, H., Chen, Y. M., Chella, A., Sugawara, S., Fu, C., Ballinger, M., Deng, Y., Srivastava, M. K., Bennett, E., Gitlitz, B. J., Wakelee, H. A. 2025: JCO2401681

Abstract

IMpower010 (ClinicalTrials.gov identifier: NCT02486718) previously showed that atezolizumab improved disease-free survival (DFS) versus best supportive care (BSC) after adjuvant chemotherapy in patients with resected non-small cell lung cancer (NSCLC). We report DFS final analysis, second overall survival (OS) interim analysis, and safety with a =5-year follow-up. Patients with completely resected stage IB-IIIA NSCLC were randomly assigned to atezolizumab (1,200 mg once every 3 weeks, 16 cycles) or BSC after platinum-based chemotherapy. At clinical cutoff (January 26, 2024), stratified hazard ratios (HRs; 95% CI) for DFS were 0.85 (95% CI, 0.71 to 1.01; P = .07) in the intention-to-treat (n = 1,005), 0.83 (95% CI, 0.69 to 1.00) in the all-randomized stage II-IIIA (n = 882), and 0.70 (95% CI, 0.55 to 0.91) in stage II-IIIA PD-L1 tumor cell (TC) =1% (n = 476) populations. Stratified HRs (95% CI) for OS were 0.97 (95% CI, 0.78 to 1.22), 0.94 (95% CI, 0.75 to 1.19), and 0.77 (95% CI, 0.56 to 1.06), respectively. The unstratified HRs (95% CI) in the stage II-IIIA PD-L1 TC =50% population (n = 229) were 0.48 (95% CI, 0.32 to 0.72) for DFS and 0.47 (95% CI, 0.28 to 0.77) for OS, and the unstratified HRs in the stage II-IIIA PD-L1 TC =50% without EGFR/ALK alterations (n = 209) population were 0.49 (95% CI, 0.32 to 0.75) and 0.44 (95% CI, 0.26 to 0.74). No new safety signals were reported. IMpower010 is the first study to report survival outcomes with a =5-year follow-up and continued to show benefit with atezolizumab versus BSC after adjuvant chemotherapy in patients with resected stage II-IIIA PD-L1-selected NSCLC.

View details for DOI 10.1200/JCO-24-01681

View details for PubMedID 40446184