Nivolumab plus chemotherapy confers sustained benefit for patients with NSCLC
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Neoadjuvant nivolumab plus platinum-based chemotherapy conferred sustained clinical benefit for patients with resectable non-small cell lung cancer, 3-year follow-up results of the phase 3 CheckMate -816 trial showed.
Researchers observed the benefit with nivolumab (Opdivo, Bristol Myers Squibb), a PD-1 immune checkpoint inhibitor, irrespective of surgical approach or extent of resection, according to updated data presented at European Lung Cancer Congress 2023 and announced in a Bristol Myers Squibb press release.
The randomized, open-label phase 3 CheckMate-816 trial evaluated platinum-based chemotherapy with and without nivolumab as neoadjuvant treatment for patients with resectable stage IB to IIIA NSCLC, regardless of PD-1 expression.
Researchers assigned 358 patients to receive either 360 mg nivolumab plus histology-based platinum doublet chemotherapy every 3 weeks for three cycles or platinum doublet chemotherapy on the same schedule, followed by surgery.
EFS and pathologic complete response served as the primary endpoints, with OS, major pathologic response and time to death or distant metastases as secondary endpoints.
With median follow-up of 41.4 months, the nivolumab combination reduced the risk for disease recurrence, progression or death by 32% (HR = 0.68; 95% CI, 0.49-0.93). Researchers reported 3-year EFS rates of 57% with the combination compared with 43% with chemotherapy alone.
The nivolumab group also had a longer time to distant metastasis or death (HR = 0.55; 95% CI, 0.39-0.78).
“These updated results from CheckMate -816 are immensely important, as they show that the addition of nivolumab to chemotherapy provides sustained efficacy over 3 years when given before surgery and provide hope for the large portion of patients with non-small cell lung cancer facing high recurrence rates and for whom cure is not feasible with surgery alone,” Nicolas Girard, MD, PhD, CheckMate -816 investigator and professor and head of Thorax Institute Curie-Montsouris, said in a press release. “As the first positive phase 3 trial with an immunotherapy-based combination in the neoadjuvant setting, the results from CheckMate -816 have already contributed valuable knowledge to the scientific community studying resectable NSCLC.”
OS remained immature at the time of the analysis; however, preliminary data showed a trend favoring the nivolumab regimen (HR = 0.62; 99.34% CI, 0.36-1.05).
Researchers reported comparable rates of grade 3 to grade 4 treatment-related adverse events (36% vs. 38%) and surgery-related adverse events (11% vs. 15%) in the nivolumab and chemotherapy groups.
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