Nivolumab Sustains Clinical Benefit Among Patients With Resectable Non-Small Cell Lung Cancer
Updated Results From the CheckMate 77T Trial
Updated Results From the CheckMate 77T Trial
According to updated results from the CheckMate 77T study, nivolumab sustained clinical benefit compared to placebo among patients with resectable non-small cell lung cancer (NSCLC).
These results were presented by Jonathan D. Spicer, MD, PhD, McGill University, Montreal, Quebec, Canada, at the 2024 European Society for Medical Oncology (ESMO) Congress.
In this study, 461 patients with resectable stage IIA to IIIB NSCLC were randomized on a 1-to-1 basis to receive either neoadjuvant nivolumab (n = 229) or placebo (n = 232) plus chemotherapy followed by either adjuvant nivolumab or adjuvant placebo. The primary end point was event-free survival (EFS) by blinded independent central review. Exploratory analyses included efficacy and safety by pathological complete response (pCR) status, ctDNA clearance, and recurrence.
At a median follow-up of 33.3 months, 2-year EFS rate was 65% in the nivolumab arm and 44% in the placebo arm. The hazard ratio for landmark EFS was 0.59 in patients who experienced pCR and 0.75 in patients who did not experience pCR. In ctDNA-evaluable patients, ctDNA clearance rate at the end of neoadjuvant treatment was 66% in the nivolumab arm and 38% in the placebo arm, and pCR rates were 50% and 12%, respectively. Recurrence rate among patients who had undetectable ctDNA at the start of adjuvant treatment was 8% in the nivolumab arm and 20% in the placebo arm, 4% in the nivolumab arm and 20% in the placebo arm among patients with pCR, and 14% in the nivolumab arm and 21% in the placebo arm among patients without pCR. Grade 3/4 treatment-related adverse events occurred in 32% of patients, respectively.
As Dr Spicer et al concluded, “These data, including comprehensive ctDNA analyses, further support perioperative [nivolumab] as an efficacious [treatment option in patients] with resectable NSCLC.”
Source:
Pulla MP, Awad M, Cascone T, et al. Perioperative nivolumab (NIVO) v placebo (PBO) in patients (pts) with resectable NSCLC: Clinical update from the phase III CheckMate 77T study. Presented at 2024 ESMO Congress. September 13-17, 2024. Abstract LBA50
