Neoadjuvant nivolumab regimen improves response in resectable NSCLC
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The addition of nivolumab to neoadjuvant chemotherapy significantly improved the pathologic complete response rate among patients with resectable non-small cell lung cancer, according to topline data released by the agent’s manufacturer.
The randomized phase 3 CheckMate-816 trial included 358 patients with resectable NSCLC.
Researchers randomly assigned patients to histology-based platinum doublet neoadjuvant chemotherapy with or without the anti-PD-1 antibody nivolumab (Opdivo, Bristol Myers Squibb) dosed at 360 mg every 3 weeks for up to three doses.
Pathologic complete response and EFS served as primary endpoints. Key secondary endpoints included OS, major pathologic response, and time to death or distant metastases.
A significantly higher percentage of nivolumab-treated patients showed no evidence of cancer cells in resected tissue.
Nivolumab exhibited a safety profile consistent with that observed in prior studies of the agent for NSCLC treatment.
The CheckMate-816 trial will continue so investigators can assess EFS outcomes, as well as secondary endpoints. Bristol Myers Squibb officials indicated they intend to submit available data for presentation at a medical conference and also share the results with regulatory authorities.
“Up to half of patients who undergo surgery for nonmetastatic lung cancer will experience disease recurrence,” Mark Awad, MD, PhD, clinical director of Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, said in a Bristol Myers Squibb-issued press release. “Nivolumab has shown benefit as an adjuvant ... treatment option in other cancer types, and the positive results from CheckMate-816 speak to its potential in the neoadjuvant setting of resectable non-small cell lung cancer. We look forward to following patients in this trial of nivolumab plus chemotherapy as a new way of treating resectable non-small cell lung cancer, with the potential that an improvement in pathologic complete response will lead to extended event-free survival and, ultimately, overall survival.”
The FDA previously approved nivolumab for several indications, including treatment of certain patients with melanoma, lung cancer, renal cell carcinoma, classical Hodgkin lymphoma or squamous cell carcinoma of the head and neck.
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