The Food and Drug Administration (FDA) has approved the combination of Opdivo (nivolumab; Bristol Myers Squibb) plus Yervoy (ipilimumab; Bristol Myers Squibb) and 2 cycles of platinum-doublet chemotherapy, for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

The approval was based on data from the CHECKMATE-9LA trial, an open-label study in patients with histologically confirmed Stage IV or recurrent NSCLC, ECOG performance status 0 or 1, and no prior anticancer therapy (including EGFR and ALK inhibitors) for metastatic disease. Patients were randomized to receive nivolumab every 3 weeks plus ipilimumab every 6 weeks and platinum-doublet chemotherapy every 3 weeks for 2 cycles (n=361) or platinum-doublet chemotherapy every 3 weeks for 4 cycles (n=358). The primary efficacy end point was overall survival (OS) and duration of response (DoR).

Results showed a statistically significant improvement in OS in patients treated with nivolumab plus ipilimumab and platinum-doublet chemotherapy compared with platinum doublet-chemotherapy alone (hazard ratio [HR] 0.69; 96.71% CI, 0.55-0.87; P =.0006) with a minimum follow up of 8.1 months. Median OS was 14.1 months (95% CI, 13.2-16.2) with the combination vs 10.7 months (95% CI, 9.5-12.5) with chemotherapy. Moreover, superior OS was observed in a follow-up analysis at 12.7 months (hazard ratio 0.66; 95% CI, 0.55-0.80).

Additionally, median duration of response was observed to be 10.0 months with nivolumab plus ipilimumab and platinum-doublet chemotherapy vs 5.1 months with chemotherapy. Statistically significant benefits were also seen in progression free survival (HR 0.70; 97.48% CI, 0.57-0.86; P =.0001) and overall response rate (P =.0003).

‘The positive findings from CheckMate -9LA demonstrate the benefit of combining dual immunotherapy with limited chemotherapy for NSCLC patients regardless of PD-L1 status,” said David P. Carbone, MD, PhD, CheckMate -9LA investigator and Director of the James Thoracic Oncology Center at The Ohio State University. “With today’s approval, more patients now have access to an Opdivo + Yervoy-based option and a chance at a longer life.”

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The combination of nivolumab, a programmed death receptor-1 blocking antibody, and ipilimumab, a human cytotoxic T-lymphocyte antigen 4-blocking antibody, was recently approved as a first-line treatment of metastatic NSCLC in adults patients whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

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