Multicenter randomized trial of TQB2450 with or without anlotinib for pretreated driver-negative non-small cell lung cancer

Immune monotherapy as second-line treatment confers only modest survival benefit for NSCLC patients without mutated driver genes, necessitating combination treatments. TQB2450 is a humanized anti-PD-L1 monoclonal antibody. A multicenter randomized trial in China compared TQB2450 plus the antiangiogenic multikinase inhibitor anlotinib versus TQB2450 plus placebo for previously treated stage IIIB or IV NSCLC with wild-type EGFR/ALK. The median PFS (primary endpoint) was 8.7 months with TQB2450 plus anlotinib versus 2.8 months with TQB2450 plus placebo. The ORR was 30.9% versus 3.0%. Toxicities were overall manageable. The authors conclude that the combination of TQB2450 and anlotinib demonstrated promising antitumor activity in aNSCLC without known driver mutations.