FDA Accepts Supplemental Biologics License Application of Nivolumab/Chemo in NSCLC


Along with the FDA, the European Medicines Agency has also accepted the application of nivolumab and chemotherapy in operable non–small cell lung cancer.

Holographic concept of lung cancer display, lung disease, treatment of lung cancer: © catalin - stock.adobe.com

Holographic concept of lung cancer display, lung disease, treatment of lung cancer: © catalin - stock.adobe.com

  • The FDA and European Medicines Agency are reviewing the application nivolumab (Opdivo) plus chemotherapy for operable non–small cell lung cancer (NSCLC) treatment, representing a potential new therapy option for these patients.
  • The CheckMate 77T trial (NCT04025879), supporting the application, showed significant improvement in event-free survival (EFS) for patients receiving nivolumab compared with placebo. The risk of disease recurrence or death was reduced by 42%.
  • The study also observed higher rates of pathologic complete response (pCR) and major pathologic response (MPR) in the nivolumab arm, suggesting better tumor shrinkage compared with placebo.

The FDA has accepted the supplemental biologics license application of neoadjuvant nivolumab plus chemotherapy followed by adjuvant nivolumab in patients with operable stage IIA to IIIB NSCLC.1 A Prescription Drug User Fee Act target action date of October 8, 2024, has been set.

The European Medicines Agency also began its centralized review process of nivolumab in this intent-to-treat population in late January.

The application is supported by findings from the phase 3 CheckMate 77T trial which met its primary end point of EFS. With a minimum follow-up of 15.7 months, the median EFS in the nivolumab arm was not reached (NR; 95% CI, 28.9-NR) vs 18.4 months (range, 13.6-28.1) in the placebo arm (HR, 0.58; 95% CI, 0.42-0.81; P =.00025).2 The risk of disease recurrence, progression, or death was reduced by 42%.

“It is a major step forward for our patients with lung cancer. We're extremely encouraged to see these results. Going forward, we have so much research to do to understand who the patients are who benefit the most from this approach, and who the patients are who have to receive different type of therapies,” Tina Cascone, MD, PhD, associate professor of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, and CheckMate 77T investigator, told Targeted OncologyTM in an interview.

Improvements were also observed in key secondary end points of pCR and MPR. pCR in the nivolumab arm was 25.3% vs 4.7% in the placebo arm. MPR was 35.4% in the nivolumab arm vs 12.1% in the placebo arm.

Regarding safety, 32% of patients in the nivolumab arm experienced treatment-related adverse events (AEs) vs 25% in the placebo arm. Both arms experienced a rate of surgery-related AEs of 12%.

1. Bristol Myers Squibb announces acceptance of U.S. 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. Bristol Myers Squibb. February 7, 2024. Accessed February 7, 2024. http://tinyurl.com/4vad5mtf
2. Cascone T, Awad MM, Spicer JD, et al. LBA1 CheckMate 77T: Phase III study comparing neoadjuvant. Nivolumab (NIVO) plus chemotherapy (chemo) vs neodadjuvant placebo plus chemo followed by surgery and adjuvant NIVO or placebo for previously untreated, resectable stage II-IIIb NSCLC. Ann Oncol. 2023;34(2):S1295. doi:10.1016/j.annonc.2023.10.050
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