Opdivo + Yervoy demonstrates durable overall survival at three years compared to chemotherapy in first-line unresectable malignant pleural mesothelioma – BMS

– Bristol Myers Squibb announced three-year data from the CheckMate -743 trial that demonstrated a durable survival benefit with first-line treatment with Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to platinum-based standard-of-care chemotherapy in patients with unresectable malignant pleural mesothelioma (MPM), regardless of histology.

With a minimum follow-up of three years (35.5 months): i Among patients treated with Opdivo plus Yervoy, 23% were alive at three years, compared to 15% of patients treated with chemotherapy. ii. Treatment with the dual immunotherapy combination continued to show a reduction in the risk of death (Hazard Ratio [HR] 0.73; 95% Confidence Interval [CI]: 0.61 to 0.87), and improvement in median overall survival (OS), the trial’s primary endpoint, vs. chemotherapy (18.1 months vs. 14.1 months, respectively). iii. The safety profile for Opdivo plus Yervoy remained consistent with previously reported data in first-line MPM, with no new safety signals identified. These data will be presented on September 17, 2021 at 13:40 CEST/7:40 a.m. EDT (Abstract #LBA65) during the Proffered Paper session at the 2021 European Society for Medical Oncology (ESMO) Virtual Congress.

“For patients with malignant pleural mesothelioma, the prognosis is generally poor, with a five-year survival rate of approximately 10%,” said Solange Peters, M.D., Ph.D., Medical Oncology Service, Chair, Thoracic Oncology, Lausanne University Hospital, Lausanne, Switzerland. “In this aggressive cancer that historically has had limited treatment options, we’ve now not only seen the potential for patients to live longer with nivolumab plus ipilimumab, but that this benefit is sustained at three years compared to treatment with chemotherapy. These results give us further proof of the durability of the outcomes achieved with this combination.”

At three years of follow-up and approximately one year of being off treatment per protocol, more patients who responded to Opdivo plus Yervoy remained in response than those treated with chemotherapy, and duration of response (DOR) was longer with the dual immunotherapy combination, regardless of histology:
i.28% of patients who responded to Opdivo plus Yervoy remained in response at three years compared to no patients (0%) in the chemotherapy arm. ii.Those treated with the dual immunotherapy combination had a median DOR of 11.6 months, compared to 6.7 months with chemotherapy. iii. Objective response rate (ORR) in patients treated with the combination was comparable to chemotherapy (39.6% vs. 44.0%, respectively).

Opdivo plus Yervoy has received approval for use in first-line unresectable MPM from 14 health authorities around the world, including in the U.S., European Union, Japan and China. Additional regulatory applications are under review globally.