CheckMate 816: Nivolumab Plus Chemotherapy for Resectable NSCLC

By: Joshua Swore
Posted: Wednesday, July 27, 2022

Nivolumab plus chemotherapy resulted in an improved treatment response compared with chemotherapy alone in patients with resectable non–small cell lung cancer (NSCLC), according to the phase III trial CheckMate 816; results were published in The New England Journal of Medicine. “In patients with resectable NSCLC, neoadjuvant nivolumab plus chemotherapy resulted in significantly longer event-free survival and a higher percentage of patients with a pathologic complete response than chemotherapy alone,” said Patrick M. Forde, MB, BCh, of Johns Hopkins Kimmel Cancer Center, Baltimore, and colleagues. 

A total of 358 patients with stage IB to IIIA resectable NSCLC were randomly assigned at a 1:1 ratio to receive nivolumab plus chemotherapy or chemotherapy alone. Following treatment, 83.2% of patients who received nivolumab plus chemotherapy were able to undergo resection, whereas 75.4% of those who received chemotherapy alone were able to undergo resection.

The authors reported that the median event-free survival for patients treated with nivolumab plus chemotherapy was 31.6 months (95% confidence interval [CI] = 30.2 months to not reached). In the chemotherapy-alone arm, the median event-free survival was 20.8 months (95% CI = 14.0–26.7 months). The pathologic complete response rate was 24.0% (95% CI = 18.0%–31.0%) among patients who received nivolumab plus chemotherapy, whereas the pathologic complete response was 2.2% (95% CI = 0.6%–5.6%) among patients who received chemotherapy alone.

The authors reported similar rates of adverse events in both treatment arms. The incidence of grade 3 or 4 adverse events was 33.5% with nivolumab plus chemotherapy and 36.9% with chemotherapy alone. The most common grade 3 or 4 event was neutropenia (8.5% with nivolumab plus chemotherapy and 11.9% with chemotherapy alone) and decreased neutrophil count (7.4% and 10.8%, respectively).

Disclosure: For full disclosures of the study authors, visit www.nejm.org.

The New England Journal of Medicine

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