Nivolumab appears to benefit patients with stage III lung cancer

Among patients with resectable stage IIIA or IIIB NSCLC (non–small-cell lung cancer), those treated with neoadjuvant nivolumab plus chemotherapy have achieved a higher level of complete response and longer survival than those treated only with chemotherapy.

Researchers reported these findings on August 10, 2023 in the NEJM/New England Journal of Medicine.

As background, the authors noted, “Approximately 20% of patients with non–small-cell lung cancer (NSCLC) receive a diagnosis of stage III disease. There is no current consensus regarding the most appropriate treatment for these patients.”

In this open-label, phase 2 trial, the investigators randomized subjects (n=86) with resectable stage IIIA or IIIB NSCLC to receive neoadjuvant nivolumab plus platinum-based chemotherapy (n=57) or chemotherapy alone (control group, n=29), followed by surgery.

The primary end point was a pathological complete response, meaning 0% viable tumor in resected lung and lymph nodes.

The investigators reported a pathological complete response in 37% of the subjects in the nivolumab group, and 7% of the control group.

Standard statistical analysis showed that progression-free survival at 24 months was 67.2% in the nivolumab group and 40.9% in the control group. Estimates of overall survival at 24 months were 85.0% in the nivolumab group and 63.6% in the control group.

The authors concluded, “Among patients with previously untreated stage IIIA or IIIB resectable NSCLC, neoadjuvant chemotherapy with nivolumab resulted in a significantly higher percentage of patients with a pathological complete response than chemotherapy alone. None of the patients who had had a pathological complete response had a relapse at 2 years of follow-up with 95.2% data maturity.”