BMS Announces Phase 3 CheckMate-816 Trial Success: Opdivo Plus Chemotherapy Achieves Primary Endpoint as Neoadjuvant Therapy in Resectable NSCLC

Bristol-Myers Squibb (BMS) recently announced that its blockbuster PD-1 inhibitor Opdivo (nivolumab), in combination with chemotherapy, met the primary endpoint of pathological complete response (pCR) in the Phase 3 CheckMate-816 clinical trial involving patients with resectable non-small cell lung cancer (NSCLC). Compared to patients receiving chemotherapy alone, a significantly higher proportion of patients treated with Opdivo (nivolumab) plus chemotherapy prior to surgery showed no evidence of cancer cells in their resected tissue. The press release noted that CheckMate-816 is the first Phase 3 clinical trial to demonstrate the clinical benefit of an immune checkpoint inhibitor combined with chemotherapy as neoadjuvant therapy for patients with non-metastatic NSCLC.

Lung cancer is one of the leading causes of cancer-related deaths worldwide. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 84% of diagnosed cases. The majority of NSCLC cases are diagnosed as non-metastatic disease (approximately 60%).Although many patients with non-metastatic NSCLC can be cured by surgery, 30% to 55% of patients still experience disease recurrence and die despite undergoing resection.. Administration before surgery (neoadjuvant therapy) and/or after surgery (adjuvant therapy) helps improve long-term patient outcomes.

In this randomized, open-label, multicenter Phase 3 clinical trial, a total of 358 patients were randomized to receive either Opdivo plus chemotherapy or doublet chemotherapy as neoadjuvant therapy, followed by resection surgery. The primary endpoints of the trial were pathological complete response and event-free survival. Bristol-Myers Squibb plans to complete a comprehensive evaluation of the data obtained from CheckMate-816, collaborate with researchers to present the results at upcoming medical conferences, and discuss potential regulatory pathways with regulatory authorities.

“Up to half of patients with non-metastatic lung cancer who undergo surgical treatment will experience disease recurrence,” said Dr. Mark Awad of the Dana-Farber Cancer Institute. “The positive results from CheckMate-816 demonstrate the potential of Opdivo as neoadjuvant therapy for patients with resectable non-small cell lung cancer. We look forward to continued follow-up of patients in this trial, hoping that the improvement in pathological complete response will translate into prolonged event-free survival and, ultimately, extended overall survival.”

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References:

[1] Opdivo (nivolumab) Plus Chemotherapy Shows Statistically Significant Improvement in Pathologic Complete Response as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial. Retrieved October 7, 2020, from https://www.businesswire.com/news/home/20201007005273/en