FDA Approves Perioperative Nivolumab in Resectable NSCLC

Microscopic, photorealistic image of lung cancer cells - Generated with Adobe Firefly

• The FDA approved nivolumab (Opdivo) plus chemotherapy for operable non–small cell lung cancer (NSCLC) treatment.
• Data from the CheckMate 77T trial (NCT04025879) supports this approval.
• In the study, a significant improvement in event-free survival (EFS) was observed among patients receiving nivolumab compared with placebo.

The FDA has approved neoadjuvant nivolumab plus chemotherapy followed by adjuvant nivolumab in patients with operable stage IIA to IIIB NSCLC, as supported by findings from the phase 3 CheckMate 77T trial.¹

Updated data were presented at the 2024 ESMO Congress, showing that perioperative nivolumab led to a benefit in EFS vs placebo in this patient population. At a median follow-up of 33.3 months (range, 23.6-52.1), those given perioperative nivolumab (n = 229) had a median EFS of 40.1 months (95% CI, 33.7-not reached) vs 17.0 months (95% CI, 13.6-28.1) in the placebo arm (n = 232; HR, 0.59; 95% CI, 0.45-0.79).^2,3 At 12 months, the EFS rates across arms were 73% (95% CI, 67%-79%) vs 59% (95% CI, 52%-65%), and the 24-month rates were 65% (95% CI, 58%-71%) vs 44% (95% CI, 38%-51%), respectively.

Patients who achieved a pathologic complete response (pCR) and received nivolumab (n = 58) demonstrated a notable EFS benefit compared with those who received a placebo (n = 11; HR, 0.59; 95% CI, 0.12-2.91). Likewise, patients in the nivolumab arm who did not achieve a pCR (n = 98) also showed an EFS benefit vs those in the placebo group without a pCR (n = 148; HR, 0.75; 95% CI, 0.51-1.09).

“It is a major step forward for our patients with lung cancer. We're extremely encouraged to see these results,” 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 Oncology^TM in an interview.

Higher rates of pathologic complete response (pCR) and major pathologic response (MPR) in the nivolumab arm were also observed, suggesting better tumor shrinkage compared with placebo. 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.⁴

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

REFERENCES:

1. FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer. News release. FDA. October 3, 2024. Accessed October 3, 2024. https://tinyurl.com/5475fws4

2. 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

3. Pulla MP, Awad MM, Cascone T, et al. Perioperative nivolumab vs placebo in patients with resectable NSCLC: clinical update from the phase 3 CheckMate 77T study. Presented at: 2024 ESMO Congress; September 13-17, 2024; Barcelona, Spain. Abstract LBA50.

4. Cascone T, Awad MM, Spicer JD, et al. LBA1 CheckMate77T: 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, resectablestage II-IIIb NSCLC. Ann Oncol. 2023;34(2):S1295. doi:10.1016/j.annonc.2023.10.050