Bristol-Myers Squibb Release: Encouraging Disease Control Rates Observed With Nivolumab Alone Or In Combination With Ipilimumab In Refractory Or Relapsing Malignant Pleural Mesothelioma Patients: Results From IFCT-1501 MAPS-2 Trial

PARIS & PRINCETON, N.J.--(BUSINESS WIRE)--The French Cooperative Thoracic Intergroup (IFCT) and Bristol-Myers Squibb Company (BMS) (NYSE:BMY) announced today results from the IFCT-1501 MAPS-2 trial evaluating the safety and efficacy of nivolumab or nivolumab combined with ipilimumab for previously treated unresectable malignant pleural mesothelioma (MPM) patients. The study was sponsored by the IFCT. Bristol-Myers Squibb supplied nivolumab and ipilimumab, and a research grant to the IFCT.

The 12-week disease control rate, the primary endpoint of the study, was 44.4% [95% CI: 31.2-57.7%] with nivolumab, and 50% [36.7-63.3%] with nivolumab plus ipilimumab, as assessed by an independent panel of radiologists. The objective response rate was 18.5% [8.2%-28.9%] with nivolumab, and 25.9% [14.2-37.6%] with nivolumab plus ipilimumab. The median overall survival was 10.4 months with nivolumab and not reached for the combined-treatment group. The progression-free survival was 4.0 months for monotherapy and 5.6 months for the combined-treatment group. The numbers of all Grade and Grade 3-4 toxicities were 86.9% and 18% in the combined-treatment group versus 77.8% and 9.5% with nivolumab alone.

These data will be featured today, June 5, during the Annual Meeting of the American Society of Clinical Oncology (ASCO) press briefing at 8:00 AM CDT and presented during an oral session from 10:12-10:24 AM CDT (Abstract LBA8507).

Arnaud Scherpereel, M.D., principal investigator of the study, head of the Pulmonary and Thoracic Oncology Department at the University Hospital (CHU) of Lille in France, stated: “For too long, patients with mesothelioma have been underserved in terms of treatment options compared with other types of cancers. The encouraging results of the previous IFCT trial, reported at the ASCO 2015 annual meeting, showed that when bevacizumab was used with the current standard-of-care combination of pemetrexed and cisplatin, it improved survival in patients with mesothelioma. Unfortunately, all patients in that study experienced disease progression. The results of IFCT-1501 MAPS-2 study, showing the efficacy and safety of nivolumab alone or in combination with ipilimumab, are promising, and additional research is needed for patients with relapsed mesothelioma.”