IMpower010: First interim OS analysis of adjuvant atezolizumab in NSCLC

The first pre-specified interim overall survival (OS) analysis of the phase 3 IMpower010 trial displayed a trend towards an OS benefit for patients with stage II–IIIA, PD-L1-positive non-small cell lung cancer (NSCLC) if they were treated with adjuvant atezolizumab instead of best supportive care (BSC) [1].

The IMpower010 trial (NCT02486718) randomised 1,005 patients with completely resected, stage IB–IIIA NSCLC 1:1 to adjuvant atezolizumab or BSC. The primary analysis demonstrated a disease-free survival benefit of atezolizumab over BSC in the subset of participants with stage II–IIIA NSCLC and ≥1% PD-L1 tumour cells histologically (TC) (HR 0.66; 95% CI 0.50–0.88; P=0.004) [2]. These results led to the approval of adjuvant atezolizumab after resection and platinum-based chemotherapy in the USA, China, and Japan if patients had stage II–IIIA disease and ≥1% PD-L1 TC, and in the EU and other countries if patients had stage II–IIIA disease and ≥50% PD-L1 TC (excluding those with EGFR mutations or ALK rearrangements). Here, Dr Enriqueta Felip (Vall d’Hebron University Hospital, Spain) presented the results of the first OS interim analysis.

After a median follow-up of 45.3 months, a trend towards an OS benefit for participants with stage II–IIIA disease and ≥1% PD-L1 TC receiving atezolizumab was reported (HR 0.71; 95% CI 0.49–1.03). The OS rates were 76.8% and 67.5% for participants in the atezolizumab and the BSC arm, respectively. These results were consistent across subgroups. In contrast, the results did not show a treatment effect on OS in all randomised stage II–IIIA patients (HR 0.95; 95% CI 0.74–1.24) or in the intention-to-treat population (randomised stage IB–IIIA; HR 0.995; 95% CI 0.78–1.28; P=0.966). Furthermore, the authors executed separate OS analyses for stage II–IIIA patients (including EGFR/ALK-mutated patients) with ≥1–49% PD-L1 TC (HR 0.95; 95% CI 0.59–1.54) and with ≥50% PD-L1 TC (HR 0.43; 95% CI 0.24–0.78). Finally, the updated safety analysis did not reveal any new signals.

1. Felip E, et al. IMpower010: Overall survival interim analysis of a phase III study of atezolizumab vs best supportive care in resected NSCLC. PL03.09, WCLC 2022, Vienna, Austria, 06–09 August.
2. Felip E, et al. Lancet. 2021 Oct 9;398(10308):1344-1357.

 

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Posted on 23 August 202223 August 2022