Phase 3 Trial Shows Neoadjuvant, Adjuvant Nivolumab Can Improve Survival in Patients With Lung Cancer

Neoadjuvant nivolumab (Opdivo; Bristol Myers Squibb[BMS]) with chemotherapy followed by surgery and adjuvant nivolumab showed statistically significant and clinically meaningful improvements in event-free survival (EFS) in patients with non-metastatic, resectable stage 2A to 3B non-small cell lung cancer (NSCLC), according to results from the phase 3 CheckMate-77T trial.¹

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“We’ve seen tremendous scientific advancements in the treatment of non-metastatic NSCLC in recent yearsand remain committed to researching new solutions that may help even more patients achieve better long-term outcomes,” said Abderrahim Oukessou, MD, vice president, thoracic cancers global program lead, Bristol Myers Squibb, in a press release.

CheckMate-77T is a phase 3, randomized, double-blind, placebo-controlled, multi-center trial that enrolled 452 patients with resectable stage 2A to 3B NSCLC. The trial compared neoadjuvant nivolumab with chemotherapy followed by surgery and adjuvant nivolumab to neoadjuvant chemotherapy with placebo followed by surgery and adjuvant placebo.

CheckMate-77T met the primary endpoint of improvement in EFS as assessed by Blinded Independent Central Review (BICR). The trial is still evaluating the secondary endpoint of overall survival (OS)—with results to be presented at an upcoming medical conference—but the previous Checkmate 227 study found that nivolumab can improve OS as part of a combination treatment.^1,2

Findings from Checkmate 227, which compared the efficacy of nivolumab plus ipilimumab (Yervoy) to chemotherapy for patients with metastatic NSCLC, found that the nivolumab combination could improve OS in patients with treatment-naive stage 4 disease and patients with recurrent NSCLC and no known EGFR/ALK alterations. After a follow-up time of 6 years, approximately half of all patients were alive and disease-free with better baseline health-related quality of life.²

Nivolumab is a programmed cell death protein 1 (PD-1) inhibitor that harnesses the body’s immune system to fight cancer. In July 2014 it became the first PD-1 immune checkpoint inhibitor to receive FDA approval and has shown efficacy as a neoadjuvant, adjuvant, or perioperative treatment for melanoma, bladder cancer, esophageal/gastroesophageal junction cancer, and lung cancer.¹

The safety profile of nivolumab and chemotherapy for NSCLC remain consistent with previous findings. Some of the most common adverse events (AEs) associated with nivolumab include rash, fatigue, musculoskeletal pain, diarrhea, nausea, pruritus, headache, and infection, according to findings from multiple clinical trials.

Lung cancer is the primary cause of cancer-related deaths, with NSCLC representing approximately 84% of lung cancer cases, of which 60% are non-metastatic. Most patients with non-metastatic NSCLC can be cured with surgery, but 30% to 35% of patients experience recurrence and die.

Reference

1. Bristol Myers Squibb Announces Perioperative Regimen of Neoadjuvant Opdivo (nivolumab) and Chemotherapy Followed by Adjuvant Opdivo Significantly Improves Event-Free Survival in Patients with Resectable Non-Small Cell Lung Cancer. Bristol Myers Squibb. News Release. September 22, 2023. Accessed on September 22, 2023. https://news.bms.com/news/corporate-financial/2023/Bristol-Myers-Squibb-Announces-Perioperative-Regimen-of-Neoadjuvant-Opdivo-nivolumab-and-Chemotherapy-Followed-by-Adjuvant-Opdivo-Significantly-Improves-Event-Free-Survival-in-Patients-with-Resectable-Non-Small-Cell-Lung-Cancer/default.aspx
2. Sava J. Nivolumab/Ipilimumab Continues to Show OS Benefit in NSCLC at 6 Years. Targeted Oncology. September 18, 2023. Accessed on September 22, 2023. https://www.targetedonc.com/view/nivolumab-ipilimumab-continues-to-show-os-benefit-in-nsclc-at-6-years