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Nivolumab Added to Perioperative Chemotherapy Improved Response, Survival Among Patients With Resectable Stage IIIA/B NSCLC
According to results from a phase 2 study, perioperative nivolumab plus platinum-based chemotherapy improved pathological complete response (pCR) and prolonged overall survival (OS) among patients with resectable stage IIIA or IIIB non-small cell lung cancer (NSCLC), compared with chemotherapy alone.
Despite approximately 20% of patients with NSCLC being diagnosed with stage III disease, “there is no current consensus regarding the most appropriate treatment for these patients,” stated Mariano Provencio, MD, PhD, Hospital Universitario Puerta de Hierro–Majadahonda, Madrid, Spain, and coauthors.
In this open-label study, 86 patients were randomly assigned to receive either neoadjuvant nivolumab plus platinum-based chemotherapy (n = 57) or chemotherapy alone (n = 29), followed by surgical resection. Patients in the nivolumab arm who had R0 resections received an additional 6 months of adjuvant nivolumab. The primary end point was pCR and secondary end points included progression-free survival (PFS), OS, and safety.
With a median follow-up duration of 24 months, the pCR rate in the nivolumab arm was 37% compared to 7% in the control arm (relative risk, 5.34; 95% confidence interval [CI], 1.34 to 21.23; P = .02). Surgical resection was performed in 93% of patients in the nivolumab arm and 69% of patients in the control arm. As estimated by Kaplan Meier analysis, 24-month PFS was 67.2% in the nivolumab arm and 40.9% in the control arm. OS was estimated at 85% and 63.6%, respectively. Grade 3/4 adverse events occurred in 11 patients (19%) in the nivolumab arm and 3 patients (10%) in the control arm.
Dr Provencio and coauthors concluded this treatment regimen provides “a higher percentage of patients with a [pCR] and longer survival than chemotherapy alone.”
Source:
Provencio M, Nadal E, González-Larriba JL, et al. Perioperative nivolumab and chemotherapy in stage III non-small cell lung cancer. N Engl J Med. Published online August 10, 2023. doi:10.1056/NEJMoa2215530
