Nivolumab-chemotherapy combination extends EFS in resectable NSCLC
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The addition of nivolumab to neoadjuvant chemotherapy significantly improved EFS among patients with resectable non-small cell lung cancer, according to topline data released by the agent’s manufacturer.
Nivolumab (Opdivo, Bristol Myers Squibb) is a PD-1 immune checkpoint inhibitor. It is approved in the United States for several indications, including treatment of certain patients with melanoma, lung cancer, renal cell carcinoma, Hodgkin lymphoma and other malignancies.
The randomized phase 3 CheckMate -816 trial included 385 patients with resectable stage IB to stage IIIA NSCLC, regardless of PD-L1 expression.
Researchers randomly assigned patients to histology-based platinum doublet chemotherapy with or without 360 mg nivolumab every 3 weeks for three doses, 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 distant metastasis.
Results of a prespecified interim analysis showed the nivolumab-chemotherapy combination conferred a statistically significant improvement in EFS. Previously reported results showed a statistically significant improvement in pathologic complete response with the combination.
The nivolumab-chemotherapy combination exhibited a safety profile consistent with that reported in other studies of patients with NSCLC.
“[Although] the intent of surgery is curative in resectable non-small cell lung cancer, between 30% to 55% of patients experience recurrence after surgery and ultimately succumb to the disease, presenting a strong need for additional options that can disrupt this cycle,” Nicolas Girard, MD, PhD, professor of respiratory medicine at Paris Saclay University and head of the Thorax Institute Curie Montsouris in Paris, said in a Bristol Myers Squibb-issued press release. “The positive event-free survival data seen with neoadjuvant nivolumab plus chemotherapy is groundbreaking and can have important implications for how we treat resectable non-small cell lung cancer.”
Complete results of CheckMate -816 will be submitted for presentation at a medical conference.
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