Dr Kalinka on Frontline BMS-986012 Plus Nivolumab and Chemotherapy in ES-SCLC

“Despite the fact that the improvement in PFS [with BMS-986012 plus nivolumab and chemotherapy] was modest, we saw an improvement in OS with separation of the curves. [Moreover,] the improvement was noted both in the populations of patients without and with brain metastases.”

Ewa Kalinka, MD, PhD, head, Department of Oncology, Instytut Centrum Zdrowia Matki Polki-Klinika Onkologil, discusses interim data from the phase 2 CA001-050 study (NCT04701880), which evaluated the first-in-class, anti-Fucosyl-GM1 monoclonal antibody BMS-986012 plus nivolumab (Opdivo) and chemotherapy in the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

According to findings presented during the 2024 ESMO Congress, the addition of BMS-986012 to nivolumab plus chemotherapy generated a modest improvement in progression-free survival (PFS) and signs of an overall survival (OS) benefit compared with nivolumab plus chemotherapy alone in this patient population, Kalinka reports. This improvement was noted regardless of whether patients displayed brain metastasis, she notes.

At an interim analysis data cutoff on August 28, 2023, with a median follow-up of 11.2 months, the median PFS with the BMS-986012 regimen (n = 66) was 5.8 months (95% CI, 5.0-7.9) compared with 5.2 months (95% CI, 4.8-6.6) for nivolumab plus chemotherapy alone (n = 66; HR, 0.89; 95% CI, 0.57-1.40; P = .61). By the later data cutoff of February 26, 2024, with a median follow-up of 17.2 months, the median PFS remained at 5.8 months (95% CI, 5.0-7.9) in the BMS-986012 arm and was 5.1 months (95% CI, 4.8-6.6) in the nivolumab plus chemotherapy arm (HR, 0.81; 95% CI, 0.53-1.23; P = .32). The 12-month PFS rates were 22% (95% CI, 12%-33%) and 19% (95% CI, 9%-31%), respectively.

At the median follow-up of 17.2 months, the median OS was 15.6 months (95% CI, 12.5-not applicable) for BMS-986012 with nivolumab plus chemotherapy compared with 11.4 months (95% CI, 9.3-16.6) for nivolumab plus chemotherapy alone (HR, 0.71; 95% CI, 0.44-1.16).

The safety profile of BMS-986012 combined with nivolumab and chemotherapy was manageable and largely consistent with that of nivolumab plus chemotherapy, with the exception of pruritus, which was not deemed a significant clinical issue, Kalinka continues. These findings provide encouragement given the challenges of balancing efficacy and toxicity in this treatment paradigm, she states. Further research is warranted to confirm the potential OS benefits of this regimen and clarify the role of BMS-986012 in combination regimens, Kalinka concludes.