Nivolumab Approved as Neoadjuvant, Adjuvant Therapy for NSCLC by FDA

The FDA has approved nivolumab (Opdivo; Bristol Myers Squibb) for adult patients who are node positive or have resectable non–small cell lung cancer (NSCLC) tumors that are at least 4 cm but who do not have EGFR Mutations or ALK rearrangements. This approval is for neoadjuvant treatment with nivolumab plus platinum-doublet chemotherapy and for adjuvant treatment with nivolumab after surgery, making nivolumab the only PD-1 inhibitor approved in both settings with proven statistically significant and clinically meaningful benefits for this patient population.¹ The approval came days before the FDA’s expected Prescription Drug User Fee Act deadline of October 8.

Bristol Myers Squibb announced it had submitted the applications for these indications for regulatory acceptance in February to the FDA and the European Medicines Agency.² Data from the phase 3 CheckMate-77T (NCT04025879) trial served as the basis of these applications.^1.2

“Given the rates of disease recurrence in patients with resectable NSCLC,” said Tina Cascone, MD, PhD, associate professor of thoracic/head and neck medical oncology at The University of Texas MD Anderson Cancer Center, in a statement, “there is a clear need for options that can be administered before and after surgery that may target micrometastasis, help reduce the risk of cancer returning and improve the chance of successful surgical treatment.”¹

Patients were randomized 1:1 to neoadjuvant nivolumab plus platinum-doublet chemotherapy—from among carboplatin, cisplatin, paclitaxel, pemetrexed, and docetaxel³—surgery, and adjuvant nivolumab, in that order (n= 229) or neoadjuvant platinum-doublet chemotherapy and placebo followed by surgery and adjuvant placebo (n = 232).

In the ongoing CheckMate-77T trial—the expected completion date is July 30, 2027—patients were enrolled who had resectable suspected or histologically confirmed stage IIA (> 4 cm) to IIIB (T3N2) NSCLC without brain metastasis, an ECOG performance status of 1 or below, and sufficient tumor tissue for biomarker analysis, and who were treatment naïve. The primary end point is event-free survival, and secondary outcomes are overall survival, pathologic complete response, major pathological response, adverse events (AEs), participants with serious AEs, and participants with select AEs.³

References

1. US Food and Drug Administration approves perioperative treatment of neoadjuvant Opdivo (nivolumab) and chemotherapy followed by surgery and adjuvant single-agent Opdivo for resectable non-small cell lung cancer (NSCLC). News release. Bristol Myers Squibb. October 3, 2024. Accessed October 4, 2024. https://news.bms.com/news/corporate-financial/2024/US-Food-and-Drug-Administration-Approves-Perioperative-Treatment-of-Neoadjuvant-Opdivo -nivolumab-and-Chemotherapy-Followed-by-Surgery-and-Adjuvant-Single-Agent-Opdivo-for-Resectable-Non-Small-Cell-Lung-Cancer-NSCLC/default.aspx

2. Bristol Myers Squibb announces acceptance of US and EU regulatory filings for neoadjuvant Opdivo (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo in resectable non-small cell lung cancer. News release. BusinessWire; February 7, 2024. Accessed October 4, 2024. https://www.businesswire.com/news/home/20240206288537/en/Bristol-Myers-Squibb-Announces-Acceptance-of-US-and-EU-Regulatory-Filings -for-Neoadjuvant-Opdivo-nivolumab-and-Chemotherapy-Followed-by-Surgery-and-Adjuvant-Opdivo-in-Resectable-Non-Small-Cell-Lung-Cancer

3. A study of neoadjuvant chemotherapy plus nivolumab versus neoadjuvant chemotherapy plus placebo, followed by surgical removal and adjuvant treatment with nivolumab or placebo for participants with surgically removable early stage non-small cell lung cancer. ClinicalTrials.gov. Updated July 23, 2024. Accessed October 4, 2024.