Multicenter phase 3 trial of first-line benmelstobart plus anlotinib versus pembrolizumab for PD-L1 posititve, advanced non-small cell lung cancer

PD-1 and PD-L1 inhibitors can synergize with anti-angiogenic agents in non-small lung cancer (NSCLC). The phase 3 CAMPASS trial, at 79 centers across China, compared benmelstobart (anti-PD-L1) plus anlotinib versus pembrolizumab plus placebo in patients with previously untreated, driver gene-negative, PD-L1-positive, advanced NSCLC. A total of 531 patients were 2:1 randomized to benmelstobart plus anlotinib (n=354) or pembrolizumab plus placebo (n=177). The primary endpoint was progression-free survival assessed by a blinded independent review committee (BIRC-PFS). After a median follow-up of 11.4 months for the benmelstobart plus anlotinib group and 10.6 months for the pembrolizumab and placebo group, the BIRC-PFS was 11.0 months and 7.1 months, respectively (HR 0.70; p=0.0057). Grade 3 or worse treatment-related adverse events occurred in 59% of patients in the benmelstobart plus anlotinib group and 21% of patients in the pembrolizumab plus placebo group, with serious TRAEs in 25% and 21%, respectively, and treatment-related deaths in 1% and 2%, respectively. Longer follow-up is required to establish impact on overall survival. The authors conclude that these results suggest that benmelstobart plus anlotinib may be a first-line option in driver gene-negative, PD-L1-positive, advanced NSCLC.