May 26, 2022 | P.M. Forde, J. Spicer, S. Lu, M. Provencio, T. Mitsudomi, M.M. Awad, E. Felip, S.R. Broderick, J.R. Brahmer, S.J. Swanson, K. Kerr, C. Wang, T.-E. Ciuleanu, G.B. Sayers, F. Tanaka, H. Ito, K.-N. Chen, M. Liberman, E.E. Vokes, J.M. Taube, C. Dorange, J. Cai, J. Fiore, A. Jarkowski, D. Balli, M. Sausen, D. Pandya, C.Y. Calvet, and N. Girard, for the CheckMate 816 Investigators
The NEJM article reports results from the CheckMate 816 trial, a phase 3 study evaluating neoadjuvant nivolumab plus chemotherapy versus chemotherapy alone in patients with resectable non-small-cell lung cancer (NSCLC). The trial enrolled 505 patients with stage IB to IIIA NSCLC, randomly assigning them to receive either nivolumab plus platinum-based chemotherapy or chemotherapy alone, followed by surgery. The primary endpoints were event-free survival and pathological complete response (0% viable tumor in resected lung and lymph nodes), assessed by blinded independent review. Secondary endpoints included overall survival and other measures of clinical benefit.
The median event-free survival was 31.6 months with nivolumab plus chemotherapy versus 20.8 months with chemotherapy alone (hazard ratio 0.63). The percentage of patients with a pathological complete response was 24.0% versus 2.2% (odds ratio 13.94). These results were consistent across most subgroups. Overall survival was also better with nivolumab plus chemotherapy, with a hazard ratio of 0.57. Adverse events were similar between the two groups, with grade 3 or 4 events occurring in 33.5% and 36.9% of patients, respectively. Surgery was feasible in both groups, with 83.2% and 75.4% of patients undergoing surgery.
The addition of nivolumab to neoadjuvant chemotherapy did not increase the incidence or severity of adverse events or impede the feasibility of surgery. The trial showed that neoadjuvant nivolumab plus chemotherapy significantly improved event-free survival and the percentage of patients with a pathological complete response compared to chemotherapy alone. These findings support the use of neoadjuvant nivolumab plus chemotherapy in resectable NSCLC. The results were consistent with previous studies and suggest that neoadjuvant immunotherapy may be a promising treatment option for resectable NSCLC. The study was funded by Bristol Myers Squibb and published in the New England Journal of Medicine.The NEJM article reports results from the CheckMate 816 trial, a phase 3 study evaluating neoadjuvant nivolumab plus chemotherapy versus chemotherapy alone in patients with resectable non-small-cell lung cancer (NSCLC). The trial enrolled 505 patients with stage IB to IIIA NSCLC, randomly assigning them to receive either nivolumab plus platinum-based chemotherapy or chemotherapy alone, followed by surgery. The primary endpoints were event-free survival and pathological complete response (0% viable tumor in resected lung and lymph nodes), assessed by blinded independent review. Secondary endpoints included overall survival and other measures of clinical benefit.
The median event-free survival was 31.6 months with nivolumab plus chemotherapy versus 20.8 months with chemotherapy alone (hazard ratio 0.63). The percentage of patients with a pathological complete response was 24.0% versus 2.2% (odds ratio 13.94). These results were consistent across most subgroups. Overall survival was also better with nivolumab plus chemotherapy, with a hazard ratio of 0.57. Adverse events were similar between the two groups, with grade 3 or 4 events occurring in 33.5% and 36.9% of patients, respectively. Surgery was feasible in both groups, with 83.2% and 75.4% of patients undergoing surgery.
The addition of nivolumab to neoadjuvant chemotherapy did not increase the incidence or severity of adverse events or impede the feasibility of surgery. The trial showed that neoadjuvant nivolumab plus chemotherapy significantly improved event-free survival and the percentage of patients with a pathological complete response compared to chemotherapy alone. These findings support the use of neoadjuvant nivolumab plus chemotherapy in resectable NSCLC. The results were consistent with previous studies and suggest that neoadjuvant immunotherapy may be a promising treatment option for resectable NSCLC. The study was funded by Bristol Myers Squibb and published in the New England Journal of Medicine.