A phase 3 clinical trial evaluating nivolumab plus chemotherapy as a neoadjuvant treatment for patients with stage IB to IIIA resectable non-small cell lung cancer met its primary endpoint of improved event-free survival, according to a release from the manufacturer. 

An interim analysis of the CheckMate-816 trial showed a benefit for patients treated with the combination compared with chemotherapy alone and followed earlier data showing the combination improved pathologic complete response. The CheckMate-816 trial evaluated 358 patients given the combination therapy every 3 weeks for 3 doses or chemotherapy alone every 3 weeks for 3 doses. Secondary endpoints of the trial include overall survival, major pathologic response, and time to death or distant metastases. 

“While 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, of Paris Saclay University and Thorax Institute Curie Montsouris in France, said in the 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.” 

The release noted that the safety profile of nivolumab and chemotherapy was consistent with previous NSCLC trials. 

Results of the trial already published were presented at the 2021 American Association for Cancer Research and 2021 American Society of Clinical Oncology annual meetings. In addition, a complete presentation of results from CheckMate-816 will be shared at a future medical conference.

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