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The phase 3 IMpower010 trial indicates a positive trend for adjuvant atezolizumab after chemotherapy in PD-L1 positive, stage II-IIIA subgroup non-small lung cancer patients
A positive benefit-risk profile of adjuvant atezolizumab after chemotherapy was shown in stage II-IIIA subgroup resected non-small cell lung cancer (NSCLC) patients in the phase 3 IMPower010 trial, recently published in Annals of Oncology.
IMPower010 was the first phase 3 immunotherapy study to demonstrate a statistically significant disease-free survival benefit with atezolizumab versus best supportive care in resected NSCLC following platinum-based chemotherapy; the greatest magnitude of disease-free survival improvement was seen in patients with PD-L1 tumor cells ≥50% stage II-IIIA NSCLC, in whom a 57% reduction in the risk of recurrence or death was observed with adjuvant atezolizumab versus best supportive care. Based on these findings, atezolizumab was approved as adjuvant treatment following platinum-based chemotherapy for patients with completely resected stage II-IIIA NSCLC and PD-L1 tumor cells ≥1% or ≥50% in many countries. Since overall survival is still an important endpoint for establishing clinical benefit in early-stage trials but was not mature after a median 32 months of follow-up, authors are now reporting the outcomes of the first pre-specified interim analysis of overall survival and safety updates after a further 13 months of median follow-up. Data show that the stratified overall survival hazard ratios were 0.95 in the stage II-IIIA, 0.71 in the stage II-IIIA and PD-L1 tumor cells ≥1% and 0.43 in the stage II-IIIA and PD-L1 tumor cells ≥50% populations. Atezolizumab-related adverse events incidence remained unchanged. «These data indicate a positive trend favoring atezolizumab in PD-L1 subgroup analyses, primarily driven by the PD-L1 tumor cells ≥50% stage II-IIIA subgroup. No new safety signals were observed after 13 months’ additional follow-up. Taken together, these findings support the positive benefit-risk profile of adjuvant atezolizumab in this setting», authors conclude.