Drugs Xagena
On march 4, 2022, the US Food and Drug Administration (FDA) approved Nivolumab ( Opdivo ) plus Platinum-doublet chemotherapy for the neoadjuvant treatment of patients with resectable non–small-cell lung cancer (NSCLC).
The approval was based on the results of CheckMate 816, an international, multiregional, active-controlled trial that randomly assigned 358 patients with resectable non–small-cell lung cancer, stage IB (greater than or equal to 4 cm) to IIIA (N2) per the American Joint Committee on Cancer ( AJCC ) seventh staging edition to receive either Nivolumab plus Platinum-doublet or Platinum-doublet chemotherapy alone for three cycles before planned surgical resection. The major efficacy end point that supported this approval was event-free survival (EFS).
At the first planned interim analysis, the hazard ratio (HR) for event-free survival was 0.63 (95% CI, 0.45 to 0.87; P = 0.0052; statistical significance boundary = 0.0262) favoring the Nivolumab plus chemotherapy arm; the median event-free survival was 31.6 months (95% CI, 30.2 to not-reached) in the Nivolumab plus chemotherapy arm versus 20.8 months (95% CI, 14.0 to 26.7) in the chemotherapy-only arm.
At the time of a prespecified interim analysis for overall survival (OS), 26% of patients had died, and the hazard ratio for overall survival was 0.57 (95% CI, 0.38 to 0.87; P = 0.0079; statistical significance boundary = 0.0033).
Eighty-three percent of patients in the Nivolumab-containing arm versus 75% in the chemotherapy-only arm received definitive surgery.
In conclusion, the approval was supported by a statistically significant and clinically meaningful improvement in event-free survival with no evidence of detriment in overall survival or negative impact on patients' receipt and timing of surgery or surgical outcomes. ( Xagena )
Akinboro O et al, J Clin Oncol 2023;41(17):3249-3259
XagenaMedicine_2023
