Perioperative Nivolumab Improves EFS in NSCLC

The addition of perioperative nivolumab can improve event-free survival (EFS) in patients with stage II-IIIB non-small cell lung cancer (NSCLC) receiving neoadjuvant chemotherapy and surgery, according to research presented at the ESMO Congress 2023.

Neoadjuvant nivolumab plus chemotherapy, followed by surgery and adjuvant nivolumab, improved EFS over chemotherapy and surgery alone in the phase 3 CheckMate 77T trial, reported study presenter Tina Cascone, MD, PhD, of the University of Texas MD Anderson Cancer Center in Houston.

CheckMate 77T (ClinicalTrials.gov Identifier: NCT04025879) enrolled patients with previously untreated, resectable stage IIA-IIIB NSCLC without EGFR or ALK mutations, and ECOG performance status scores of 0 or 1.

A total of 461 patients were randomly assigned to receive the nivolumab regimen (n=229) or placebo (n=232). Patients in the nivolumab arm received neoadjuvant nivolumab (360 mg every 3 weeks) plus platinum-doublet chemotherapy for 4 cycles, followed by surgery and adjuvant nivolumab (480 mg every 4 weeks for 1 year). Patients in the control arm received neoadjuvant chemotherapy and placebo, followed by surgery and adjuvant placebo.

At a median follow-up of 25.4 months, the median EFS was not reached in the nivolumab arm and was 18.4 months in the placebo arm (hazard ratio, 0.58; 97.36% CI, 0.42-0.81; P =.00025).

The 12-month EFS rate was 73% in the nivolumab arm and 59% in the placebo arm. The 24-month EFS rate was 70% and 50%, respectively.

Nivolumab was also associated with improved response rates. The pathologic complete response rate was 25.3% in the nivolumab arm and 4.7% in the placebo arm (odds ratio [OR], 6.64; 95% CI, 3.40-12.97). The major pathologic response rate was 35.4% and 12.1%, respectively (OR, 4.01; 95% CI, 2.48-6.49).

In the overall study period, the rate of treatment-related adverse events (TRAEs) was 89% in the nivolumab arm and 87% in the placebo arm. The rate of grade 3-4 TRAEs was 32% and 25%, respectively.

In the neoadjuvant period, the rate of TRAEs was 86% in the nivolumab arm and 85% in the placebo arm. The rate of grade 3-4 TRAEs was 27% and 23%, respectively.

In the adjuvant period, the rate of TRAEs was 50% in the nivolumab arm and 30% in the placebo arm. The rate of grade 3-4 TRAEs was 8% and 3%, respectively.

There were 2 treatment-related deaths in the nivolumab arm. Both were due to pneumonitis, and both occurred during the neoadjuvant period.

These results support the use of perioperative nivolumab as a potential new treatment option for patients with resectable NSCLC, Dr Cascone said.

Disclosures: This research was supported by Bristol Myers Squibb. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

This article originally appeared on Cancer Therapy Advisor