Multicenter randomized phase 3 trial of first-line benmelstobart, anlotinib, and chemotherapy for extensive-stage small cell lung cancer

Immunochemotherapy is the first-line standard for extensive-stage small cell lung cancer (ES-SCLC). Combining this regimen with anti-angiogenesis may improve efficacy. The phase 3 ETER701 trial, at 72 centers in China randomized patients with previously untreated ES-SCLC 1:1:1 to benmelstobart (anti-PD-L1) plus anlotinib plus etoposide-carboplatin (EC) chemotherapy (n=246), placebo plus anlotinib and EC (n=245), or double placebo and EC (n=247), follwed by matching maintenance therapy. Primary endpoints were overall survival and progression-free survival. OS was signficantly improved with benmelstobart plus anlotinib plus EC versus EC alone, but not with anlotinib plus EC versus EC alone. PFS was significantly improved with benmelstobart plus anlotinib plus EC versus EC alone, and with anlotinib plus EC versus EC alone. The incidence of grade 3 or higher treatment-related adverse events was 93.1%, with benmelstobart, anlotinib and EC, compared with 94.3% with anlotinib and EC, and 87.0% with EC alone. The authors conclude that the combination of first-line benmelstobart and anlotinib plus EC resulted in a median OS greater than recorded in prior randomized studies in patients with ES-SCLC, with a tolerable and manageable safety profile.