Details

Autor(en) / Beteiligte

• Felip, E.
• Altorki, N.
• Zhou, C.
• Vallières, E.
• Martínez-Martí, A.
• Rittmeyer, A.
• Chella, A.
• Reck, M.
• Goloborodko, O.
• Huang, M.
• Belleli, R.
• McNally, V.
• Srivastava, M.K.
• Bennett, E.
• Gitlitz, B.J.
• Wakelee, H.A.

Titel

Overall survival with adjuvant atezolizumab after chemotherapy in resected stage II-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase III trial

Ist Teil von

• Annals of oncology, 2023-10, Vol.34 (10), p.907-919

Ort / Verlag

Elsevier Ltd

Erscheinungsjahr

2023

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• IMpower010 (NCT02486718) demonstrated significantly improved disease-free survival (DFS) with adjuvant atezolizumab versus best supportive care (BSC) following platinum-based chemotherapy in the programmed death-ligand 1 (PD-L1)-positive and all stage II-IIIA non-small-cell lung cancer (NSCLC) populations, at the DFS interim analysis. Results of the first interim analysis of overall survival (OS) are reported here. The design, participants, and primary-endpoint DFS outcomes have been reported for this phase III, open-label, 1 : 1 randomised study of atezolizumab (1200 mg q3w; 16 cycles) versus BSC after adjuvant platinum-based chemotherapy (1-4 cycles) in adults with completely resected stage IB (≥4 cm)-IIIA NSCLC (per the Union Internationale Contre le Cancer and American Joint Committee on Cancer staging system, 7th edition). Key secondary endpoints included OS in the stage IB-IIIA intent-to-treat (ITT) population and safety in randomised treated patients. The first pre-specified interim analysis of OS was conducted after 251 deaths in the ITT population. Exploratory analyses included OS by baseline PD-L1 expression level (SP263 assay). At a median of 45.3 months’ follow-up on 18 April 2022, 127 of 507 patients (25%) in the atezolizumab arm and 124 of 498 (24.9%) in the BSC arm had died. The median OS in the ITT population was not estimable; the stratified hazard ratio (HR) was 0.995 [95% confidence interval (CI) 0.78-1.28]. The stratified OS HRs (95% CI) were 0.95 (0.74-1.24) in the stage II-IIIA (n = 882), 0.71 (0.49-1.03) in the stage II-IIIA PD-L1 tumour cell (TC) ≥1% (n = 476), and 0.43 (95% CI 0.24-0.78) in the stage II-IIIA PD-L1 TC ≥50% (n = 229) populations. Atezolizumab-related adverse event incidences remained unchanged since the previous analysis [grade 3/4 in 53 (10.7%) and grade 5 in 4 (0.8%) of 495 patients, respectively]. Although OS remains immature for the ITT population, these data indicate a positive trend favouring atezolizumab in PD-L1 subgroup analyses, primarily driven by the PD-L1 TC ≥50% stage II-IIIA subgroup. No new safety signals were observed after 13 months’ additional follow-up. Together, these findings support the positive benefit–risk profile of adjuvant atezolizumab in this setting. •Atezolizumab significantly improved DFS versus BSC after resection and adjuvant chemo in PD-L1+ stage II-IIIA NSCLC.•Atezolizumab appears to extend OS versus BSC post resection and adjuvant chemo in PD-L1 TC ≥50% stage II-IIIA NSCLC.•Although OS was immature, a positive trend favouring atezolizumab that was greatest in the PD-L1 TC ≥50% stage II-IIIA group.