FDA approves Opdivo with chemotherapy as neoadjuvant treatment for certain adult patients with resectable non-small cell lung cancer.-BMS
Bristol Myers Squibb announced that the FDA approved Opdivo (nivolumab) 360 mg (injection for intravenous use) in combination with platinum-doublet chemotherapy every three weeks for three cycles for adult patients with resectable (tumors greater than 4 cm or node positive) non-small cell lung cancer (NSCLC) in the neoadjuvant setting.Opdivo plus chemotherapy is approved regardless of PD-L1 status.
The approval is based on the CheckMate -816 trial, the first positive Phase III trial of an immunotherapy-based combination used before surgery for resectable NSCLC. The primary endpoints included event-free survival (EFS) and pathologic complete response (pCR), which were evaluated using independent blinded review, and an additional efficacy outcome measure was overall survival (OS). The study compared Opdivo plus platinum-doublet chemotherapy (n=179) to platinum-doublet chemotherapy alone (n=179). In the trial, when given before surgery, Opdivo plus chemotherapy showed a statistically significant improvement in EFS with a 37% reduction in the risk of progression, recurrence or death (Hazard Ratio [HR] 0.63; 95% Confidence Interval [CI]: 0.45 to 0.87; P=0.0052) compared to chemotherapy alone.Opdivo plus chemotherapy showed a median EFS of 31.6 months (95% CI: 30.2 to Not Reached [NR]) compared to 20.8 months for patients treated with chemotherapy alone (95% CI: 14.0 to 26.7).
Additionally, 24% of patients treated with Opdivo plus chemotherapy achieved pCR (95% CI: 18.0 to 31.0), compared to 2.2% of patients treated with chemotherapy alone (95% CI: 0.6 to 5.6; estimated treatment difference 21.6; 95% CI: 15.1 to 28.2; P<0.0001). a prespecified interim analysis for os resulted in a hr of 0.57 (95% ci: 0.38 to 0.87), which did not cross the boundary for statistical significance.></0.0001).>
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