Adjuvant atezolizumab can improve disease-free survival (DFS), compared with best supportive care (BSC), in patients with stage II-IIIA non-small cell lung cancer (NSCLC) and high PD-L1 expression, according to results from the phase 3 IMpower010 trial.1

IMpower010 is the first phase 3 immunotherapy study to demonstrate a significant DFS improvement in the adjuvant setting after platinum-based chemotherapy, according to Enriqueta Felip, MD, PhD, of Vall d’Hebron University Hospital in Barcelona, Spain.

Dr Felip presented results from the trial at the 2022 European Lung Cancer Congress (ELCC).


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The IMpower010 trial (ClinicalTrials.gov Identifier: NCT02486718) enrolled 1280 patients with completely resected stage IB-IIIA NSCLC. They received cisplatin plus pemetrexed, gemcitabine, docetaxel, or vinorelbine for 1 to 4 cycles. Then, 1005 patients were randomly assigned to receive either atezolizumab at 1200 mg every 21 weeks for 16 cycles (n=507) or BSC (n=498).

At the interim analysis, there was a significant DFS benefit with atezolizumab compared with BSC in all patients with stage II-IIIA disease (hazard ratio [HR], 0.79; 95% CI, 0.64-0.96; P =.020) and in patients who had stage II-IIIA disease with PD-L1 expression of 1% or higher (HR, 0.66; 95% CI, 0.50-0.88; P =.0039).2

The current analysis1 included 229 patients with stage II-IIIA disease and PD-L1 expression of at least 50%. In this group, 115 patients received atezolizumab and 114 received BSC. Baseline characteristics were similar between the treatment groups.

The median DFS was not reached in the atezolizumab arm and was 35.7 months in the BSC arm (HR, 0.43; 95% CI, 0.27-0.68). At 24 months, the DFS rate was 87.1% in the atezolizumab arm and 61.6% in the BSC arm. At 36 months, the DFS rate was 73.8% and 48.6%, respectively.

Results were similar when the researchers excluded patients who had EGFR or ALK mutations. The median DFS was not reached in the atezolizumab arm and was 37.3 months in the BSC arm (HR, 0.43; 95% CI, 0.26-0.71). At 24 months, the DFS rate was 87.0% in the atezolizumab arm and 63.6% in the BSC arm. At 36 months, the DFS rate was 75.1% and 50.4%, respectively.

Dr Felip said the overall survival data in this population are not yet mature, so further follow-up is needed.

The overall safety profile in patients with stage II-IIIA disease and high PD-L1 expression was consistent with that in the entire study population and the known safety profile of atezolizumab, according to Dr Felip.

“These findings in the PD-L1 50% or higher stage II-IIIA population build on the positive benefit-risk profile for atezolizumab in PD-L1-positive NSCLC and support its use as adjuvant treatment,” Dr Felip concluded.

Disclosures: This research was supported by F. Hoffmann-La Roche, Ltd. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

References

  1. Felip E, Altorki NK, Zhou C, et al. Atezolizumab (atezo) vs best supportive care (BSC) in stage II-IIIA NSCLC with high PD-L1 expression: Sub-analysis from the pivotal phase III IMpower010 study. Presented at ELCC 2022; March 30 – April 2, 2022. Abstract 800.
  2. Felip E, Altorki N, Zhou C, et al. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): A randomised, multicentre, open-label, phase 3 trial. Lancet. 2021;398(10308):1344-1357. doi:10.1016/S0140-6736(21)02098-5