According to interim analysis results from a phase 2 study, the addition of BMS-986012, a first-in-class, fully human immunoglobulin G1 (IgG1) monoclonal antibody, to carboplatin plus etoposide and nivolumab demonstrated promising efficacy and safety as first-line treatment for patients with extensive-stage small cell lung cancer (SCLC). 

These results were presented by Ewa Kalinka, MD, PhD, Polish Mother’s Health Center Institute, Lodz, Poland, at the 2024 European Society for Medical Oncology (ESMO) Congress. 

Previously, BMS-986012 showed preliminary antitumor activity, combined with nivolumab, among patients with SCLC. In this study, 132 patients were randomized on a 1-to-1 basis to receive four 21-day cycles of carboplatin plus etoposide and nivolumab either with (n = 66), or without (n = 66) BMS-986012, followed by up to 2 years of nivolumab maintenance with or without BMS-986012. The primary end point was progression-free survival (PFS), by blinded independent central review. Key secondary end points included overall survival (OS) and safety. 

At analysis, median PFS was 5.8 months in the BMS-986012 arm and 5.2 months in the control arm (hazard ratio [HR] 0.89; 95% confidence interval [CI], 0.57 to 1.40; P = .61). Median OS was 15.6 months and 11.4 months, respectively. Grade 3/4 adverse events were experienced by 51% of patients in the BMS-986012 arm and 55% of patients in the control arm and serious adverse events were experienced by 51% and 45% of patients, respectively. There were 2 treatment-related deaths in the BMS-986012 arm and 3 treatment-related deaths in the control arm. 

Dr Kalinka et al concluded that BMS-986012 in combination with carboplatin-etoposide and nivolumab showed tolerable safety as a first-line treatment for extensive-stage SCLC, “alongside a promising signal of improved OS” compared to carboplatin-etoposide and nivolumab alone.

Source: 

Bahce I, Mendivil AFN, Ready N, et al. BMS-986012 (anti-fucosyl-monosialoganglioside-1 [fuc-GM1]) with carboplatin + etoposide + nivolumab (CE/NIVO) as first-line (1L) therapy in extensive-stage small cell lung cancer (ES-SCLC): Interim analysis (IA) of a randomized phase II study. Presented at 2024 ESMO Congress. September 13-17, 2024. Abstract 1786O