The FDA has initiated a priority review for neoadjuvant nivolumab plus chemotherapy to treat patients with resectable non–small cell lung cancer.
The FDA has accepted a supplemental biologics license application (sBLA) for neoadjuvant nivolumab plus chemotherapy to treat resectable non–small cell lung cancer (NSCLC). Notably, if the combination were approved, this combination would become the first available neoadjuvant immunotherapy combination option for this patient population, according to a news release.1
The sBLA is supported by findings from the CheckMate 816 trial (NCT02998528), which showed that the combination elicited a significantly improved event-free survival in patient with resectable NSCLC. In addition, at the 2021 AACR Annual Meeting, data were presented that demonstrated a significantly improved pathological complete response rate with the combination compared with those who received chemotherapy alone (24% vs 2.2%, respectively).2 The combination was not associated with an increase in overall toxicity or surgery delays.
Moreover, surgical outcomes revealed that the definitive surgery rates were 83% with nivolumab plus chemotherapy compared with 75% with chemotherapy alone, according to findings presented at the 2022 ASCO Annual Meeting.3 Reasons for surgery cancellation included disease progression, adverse events (AEs), as well as patient refusal, unrespectability, and poor lung function.
“While significant progress has been made in how we treat [patients with] non–small cell lung cancer, there remains a strong need for new options that can prevent recurrence and improve clinical outcomes, especially when a patient’s cancer is caught in earlier stages,” Abderrahim Oukessou, MD, vice president, thoracic cancers development lead, of Bristol Myers Squibb, the developer of nivolumab, stated in a press release. “The FDA’s acceptance of our application marks an important step in our effort to offer patients and physicians the first immunotherapy-based option that can be given before surgery to extend the time patients can continue living without disease progression or recurrence. We look forward to working with the FDA to potentially bring this regimen to patients in the [United States], where lung cancer is the leading cause of cancer deaths.”
CheckMate 816 is an ongoing phase 3, randomized, open label, multicenter trial comparing neoadjuvant nivolumab plus chemotherapy against chemotherapy alone in patients with stage IB to IIIA, resectable NSCLC, regardless of PD-L1 expression. The trial enrolled 358 patients who were randomized to receive either 360 mg of nivolumab along with histology-base platinum doublet chemotherapy every 3 weeks for 3 doses, or platinum doublet chemotherapy every 3 weeks for 3 doses, before undergoing surgery. Primary end points are pathologic complete response (pCR) and event-free survival (EFS) while secondary end points are overall survival (OS), major pathologic response (MPR), and time to death or distant metastases.
Under the Prescription Drug User Fee Act, the decision date for the application has been set for July 13, 2022.