Nivolumab and chemotherapy in advanced non–small‐cell lung cancer

Five‐year safety and efficacy data from a phase Ib study of nivolumab and chemotherapy in advanced non–small‐cell lung cancer:

Abstract

Combination anti‐programmed death 1/programmed death‐ligand 1 antibody and platinum‐based chemotherapy is standard first‐line treatment for advanced non–small‐cell lung cancer without targetable oncogene alterations. We describe the long‐term safety and efficacy data from a previously reported phase Ib study of nivolumab and chemotherapy. Japanese patients with non–small‐cell lung cancer were assigned to a treatment arm based on histology and treatment history. Nivolumab (10 mg/kg, intravenous) and chemotherapy (four arms) were administered every 3 weeks: arm A, four cycles of cisplatin and gemcitabine (first‐line); arm B, four cycles of cisplatin and pemetrexed followed by pemetrexed maintenance therapy (first‐line); arm C, 4–6 cycles of carboplatin, paclitaxel, and bevacizumab followed by bevacizumab (first‐line); arm D, docetaxel (second‐ or third‐line). Study treatments were continued every 3 weeks as maintenance therapy until disease progression. Minimum follow‐up period was 57.9 months. Median progression‐free survival (median [range]) was 6.3 (0.7+–47.8), 11.8 (1.4–65.1+), 40.7 (5.3–60.8+), and 3.2 (1.9–10.9) months, and 5‐year progression‐free survival was observed in 0/6, 1/6, 1/6, and 0/6 patients in arms A, B, C, and D, respectively. Median overall survival was 13.2 (11.0–55.4), 28.5 (14.6–66.2+), not reached (24.2–67.4+), and 12.5 (9.8–16.9) months; and the number of patients surviving 5 years were 0/6, 1/6, 4/6, and 0/6 in arms A, B, C, and D, respectively. No unexpected severe adverse events or treatment‐related deaths occurred. Nivolumab and platinum‐based chemotherapy combinations showed long‐term tolerability. A moderate proportion of patients in arm C exhibited 5‐year progression‐free and overall survival.