Nivolumab Approved for Neoadjuvant/Adjuvant Treatment of Resectable Non–Small Cell Lung Cancer
Expert Perspectives · Lyn Brook · 2024-10-03
The FDA has granted approval to nivolumab (Opdivo®, Bristol Myers Squibb Company) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable non–small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
Why it matters: “Standard treatment with neoadjuvant nivolumab plus chemotherapy significantly improves outcomes in patients with resectable NSCLC,” wrote Tina Cascone, MD, PhD, Associate Professor in the Department of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center, and colleagues, in their published results of the CHECKMATE-77T trial (NCT04025879), on which approval was based. “Perioperative treatment (ie, neoadjuvant therapy followed by surgery and adjuvant therapy) with nivolumab may further improve clinical outcomes.”
What they studied: Efficacy was measured in the phase 3, double-blind, placebo-controlled trial which enrolled 461 patients with previously untreated and resectable NSCLC—stage IIA to select stage IIIB. Patients were randomized 1:1 to receive either nivolumab or placebo plus platinum-based chemotherapy every three weeks for up to four cycles as neoadjuvant treatment, followed by continued treatment with single-agent nivolumab or placebo every four weeks for up to 13 cycles as adjuvant treatment.
The primary efficacy outcome measured was event-free survival as assessed by Blinded Independent Central Review (BICR).
What they found: The median event-free survival was not reached in the nivolumab arm compared with 18.4 months in the placebo arm. In addition, overall survival saw no detriment, although it was not formally tested for statistical significance at the time of the prespecified interim analysis.
Adverse events: Patients being treated with nivolumab with chemotherapy had similar adverse events to those occurring in other clinical trials. For those who received neoadjuvant nivolumab, 5.3% were unable to undergo surgery due to adverse events in comparison to 3.5% in the placebo arm. Additionally, 4.5% of those who received neoadjuvant treatment and surgery in the nivolumab arm had delays in surgery due to adverse events in comparison to 3.9% in the placebo arm. Refer to the prescribing information for complete safety information.
Conclusion: “Perioperative treatment with nivolumab resulted in significantly longer event-free survival than chemotherapy in patients with resectable NSCLC,” concluded Dr. Cascone and colleagues.
Instructions: The recommended dosage of nivolumab is 360 mg every three weeks for neoadjuvant treatment and 480 mg every four weeks for adjuvant treatment. Nivolumab should be administered prior to chemotherapy when administered on the same day.