FDA approves neoadjuvant Opdivo regimen for non-small cell lung cancer
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The FDA approved nivolumab with platinum doublet chemotherapy as neoadjuvant treatment for adults with resectable non-small cell lung cancer.
The regimen — which received FDA priority review designation in February — is the first neoadjuvant immunotherapy-based option for patients with resectable NSCLC in the United States.
Nivolumab (Opdivo, Bristol Myers Squibb), a PD-1 immune checkpoint inhibitor, is approved in the United States for several oncology indications.
The FDA based the new indication on results of the randomized phase 3 CheckMate -816 trial, which enrolled patients with resectable NSCLC regardless of PD-L1 expression.
The primary analysis included 358 patients with stage IB, stage II or stage IIIA NSCLC with ECOG performance status of 0 or 1.
Researchers randomly assigned 179 patients to 360 mg nivolumab plus histology-based platinum-doublet chemotherapy on the same day every 3 weeks for up to three cycles, followed by surgery. The other 179 patients received chemotherapy alone followed by surgery.
Pathologic complete response and EFS served as the primary endpoints. Secondary endpoints included OS, major pathologic response, and time to death or metastases.
Results showed the nivolumab-chemotherapy combination significantly improved EFS (median, 31.6 months vs. 20.8 months; HR = 0.63; 95% CI, 0.45-0.87) and pathologic complete response rate (24% vs. 2.2%; estimated treatment difference, 21.6%; 95% CI, 15.1-28.2).
A prespecified interim analysis for OS favored the nivolumab regimen but did not reach the boundary for statistical significance (HR = 0.57; 95% CI, 0.38-0.87).
The combination exhibited a safety profile consistent with that observed in prior studies in NSCLC.
“Given the rates of disease recurrence in patients with resectable NSCLC, additional treatment options are needed that can be given before surgery to help improve the chance of successful surgical treatment and support the goal of reducing the risk of cancer returning,” Mark Awad, MD, PhD, investigator on the CheckMate -816 study and clinical director of Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, said in a Bristol Myers Squibb-issued press release. “The approval of nivolumab with platinum-doublet chemotherapy marks a turning point in how we treat resectable NSCLC and it enables us to use immunotherapy and chemotherapy as neoadjuvant treatment for patients before surgery.”
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