Bristol Myers Squibb (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved Opdivo® (nivolumab) for adult patients with resectable non-small cell lung cancer (NSCLC) with tumors ≥4 cm or node-positive, and no known EGFR mutations or ALK rearrangements. This approval allows for neoadjuvant treatment in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant treatment after surgery, known as perioperative therapy. The decision is based on positive results from the CheckMate-77T trial, marking the second successful Phase 3 trial for an immunotherapy-based combination in treating resectable NSCLC. Opdivo is now the only PD-1 inhibitor shown to provide significant benefits in both neoadjuvant and perioperative settings compared to chemotherapy.
“Given the high rates of disease recurrence in patients with resectable non-small cell lung cancer (NSCLC), there is a pressing need for therapies that can be administered before and after surgery to target micrometastases, reduce cancer recurrence risk, and enhance surgical outcomes,” said Dr. Tina Cascone, associate professor of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. “This approval marks a significant advancement for patients with resectable disease, as the combination of nivolumab with neoadjuvant chemotherapy offers improved event-free survival (EFS) compared to chemotherapy alone and shows potential for achieving a pathological complete response (pCR) in one in four patients.”
The CheckMate-77T trial investigated the efficacy of neoadjuvant Opdivo combined with platinum-doublet chemotherapy followed by surgery and adjuvant Opdivo monotherapy (n=229) against a control group receiving chemotherapy and placebo (n=232) in adult patients with resectable NSCLC. The Opdivo group demonstrated significant improvement in EFS, a primary endpoint, along with a high pCR rate as a key secondary endpoint.
Results showed a 42% reduction in the risk of disease recurrence, progression, or death (EFS Hazard Ratio [HR] 0.58; 95% Confidence Interval [CI]: 0.43 to 0.78; P=0.00025) in the Opdivo-treated patients, with a median follow-up of 25.4 months. Additionally, 70% of patients in the Opdivo arm achieved 18-month EFS, compared to 50% in the chemotherapy and placebo group. Notably, 25% of the Opdivo group achieved pCR, versus only 4.7% in the comparator arm.
Opdivo comes with warnings and precautions for serious immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, and nephritis, as well as risks associated with infusion reactions and embryo-fetal toxicity. Use of PD-1 or PD-L1 inhibitors in combination with certain other treatments is not recommended outside clinical trials.
“This milestone broadens the application of Opdivo-based therapies and builds on the foundation established by the FDA’s prior approval of neoadjuvant Opdivo plus chemotherapy for resectable NSCLC,” said Wendy Short Bartie, senior vice president of U.S. Oncology and Hematology at Bristol Myers Squibb. “With this new regimen, we reaffirm our commitment to enhancing patient outcomes and expanding our thoracic portfolio in early-stage disease.”
The recommended dosage for Opdivo in this context is 360 mg with platinum-doublet chemotherapy every three weeks for up to four cycles or until disease progression or unacceptable toxicity, followed by single-agent Opdivo at 480 mg every four weeks for up to 13 cycles post-surgery.
About CheckMate-77T
CheckMate-77T is a Phase 3 randomized, double-blind trial assessing the neoadjuvant use of Opdivo combined with platinum-doublet chemotherapy followed by surgery and adjuvant Opdivo compared to a control regimen.
About Lung Cancer
Lung cancer remains the leading cause of cancer-related deaths in the U.S., with non-small cell lung cancer (NSCLC) accounting for up to 85% of cases. While surgery may be an effective treatment for early-stage non-metastatic NSCLC, 30% to 55% of patients experience recurrence, highlighting the necessity for neoadjuvant and adjuvant treatment options to improve long-term outcomes.
