FDA approves Opdivo regimen for resectable NSCLC
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The FDA expanded the approval of nivolumab for treatment of non-small cell lung cancer.
The new indication authorizes use of the agent with platinum-doublet chemotherapy in the neoadjuvant setting, followed by monotherapy in the adjuvant setting, for adults with resectable NSCLC who have no known EGFR or ALK rearrangements.
Nivolumab (Opdivo, Bristol Myers Squibb) is an anti-PD-1 antibody.
Neoadjuvant nivolumab plus chemotherapy has become the standard of care for individuals with resectable NSCLC based on results of the CheckMate 816 trial, which showed improved EFS and pathologic complete response with the combination vs. chemotherapy alone.
The randomized phase 3 CHECKMATE-77T trial included 461 adults with previously untreated, resectable stage IIA to stage IIIB NSCLC.
Researchers randomly assigned patients half of the trial participants to receive neoadjuvant platinum-based chemotherapy plus nivolumab every 3 weeks for up to four cycles, followed by adjuvant nivolumab monotherapy every 4 weeks for up to 13 cycles. The other half received neoadjuvant chemotherapy plus placebo, followed by placebo in the adjuvant setting.
EFS served as the major efficacy outcome.
Results of a prespecified interim analysis showed longer median EFS in the nivolumab group than the placebo group (not reached vs. 18.4 months; HR = 0.58; 95% CI, 0.43-0.78).
OS had not been formally tested for statistical significance at time of the interim analysis; however, a descriptive analysis showed no detriment to survival with the addition of nivolumab.
Comparable percentages of patients assigned nivolumab and placebo did not undergo surgery due to adverse reactions (5.3% vs. 3.5%) or required delays in surgery due to adverse reactions (4.5% vs. 3.9%).
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