CheckMate 77T Analysis Evaluates Perioperative Nivolumab in Resectable NSCLC

Perioperative nivolumab showed a clinical benefit compared with placebo in stage III non-small cell lung cancer (NSCLC) with or without N2 nodal status, according to an exploratory analysis of the CheckMate 77T study.

Previous results from CheckMate 77T showed that perioperative nivolumab significantly improved event-free survival (EFS) in patients with stage II-IIIB resectable NSCLC compared with placebo.

In CheckMate 77T, patients with stage IIA-IIIB NSCLC were randomly assigned to receive neoadjuvant nivolumab every 3 weeks plus chemotherapy followed by adjuvant nivolumab every 4 weeks or neoadjuvant placebo plus chemotherapy followed by adjuvant placebo. The primary endpoint was EFS per blinded independent central review.

At the 2024 American Society of Clinical Oncology Annual Meeting, Tina Cascone, MD, PhD, of The University of Texas MD Anderson Cancer Center, presented clinical outcomes from CheckMate 77T for patients with baseline stage III N2 and non-N2 NSCLC. Among patients with stage III N2 disease, 91 were assigned to nivolumab and 90 were assigned to placebo; for stage III non-N2 disease, 55 patients were assigned to receive nivolumab, and 57 to placebo.

Pathologic complete response (pCR) was improved in all patients in this exploratory analysis. In stage III N2 disease, the pCR rate was 22% in those recieving nivolumab, compared with 5.6% in those recieving placebo. In non-N2 disease, the pCR rate was 25.5% in those recieving nivolumab compared with 5.3% in those recieving placebo.

“Approximately 80% of patients in both clinical subgroups underwent surgery after neoadjuvant treatment,” Dr. Cascone said.

In a sensitivity analysis of pCR in only patients who underwent resection, the pCR rates were 28.6% for nivolumab and 7.6% for placebo in N2 disease. In those with non-N2 disease, the pCR rates were 31.1% with nivolumab and 6.7% with placebo.

Patients with N2 and non-N2 disease also had EFS benefits with nivolumab. In N2 disease, the median EFS was 30.2 months for perioperative nivolumab compared with 10.0 months with placebo (hazard ratio [HR]=0.46; 95% CI, 0.30-0.70). In non-N2 disease, the median EFS was not reached with nivolumab compared with 17.0 months with placebo (HR=0.60; 95% CI, 0.33-1.08).

Almost three-quarters of patients with N2 disease (70%) and non-N2 disease (74%) remained recurrence free at one year after randomization as compared with 45% and 62%, respectively, of patients assigned to placebo.

Patients with N2 NSCLC had similar surgical feasibility as patients with non-N2 disease after neoadjuvant nivolumab plus chemotherapy; 86% of surgeries were R0.

“Patients with N2 and non-N2 disease who underwent surgery continued to derive benefit in the  adjuvant nivo phase versus placebo, with an HR of 0.32 and 0.61, respectively,” Dr. Cascone said.

Additionally, patients with N2 and non-N2 disease with pCR had improved EFS after surgery compared with those who did not have a pCR in both the nivolumab and placebo arms. In patients without pCR, there was an EFS improvement with nivolumab compared with placebo, particularly in patients with N2 disease (HR, 0.48; 95% CI, 0.27-0.86).

According to Dr. Cascone, perioperative nivolumab had similar safety outcomes in N2 and non-N2 subgroups.

“In conclusion, these findings, along with previously reported results from the CheckMate 77T study, further support perioperative nivolumab as a potential new treatment for patients with resectable NSCLC, including those with poor prognosis such as stage III N2,” Dr. Cascone concluded.

This study was funding by Bristol Myers Squibb.

Reference

Provencio M, Awad MM, Spicer J, et al. Clinical outcomes with perioperative nivolumab (NIVO) by nodal status among patients (pts) with stage III resectable NSCLC: Results from the phase 3 CheckMate 77T study. Presented at the 2024 American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2024, Chicago, Illinois.