It has been announced that CheckMate -743, a pivotal phase 3 trial nivolumab in combination with ipilimumab in previously untreated malignant pleural mesothelioma (MPM) met its primary endpoint of overall survival (OS).

Based on a pre-specified interim analysis conducted by the independent Data Monitoring Committee, nivolumab in combination with ipilimumab resulted in a statistically significant and clinically meaningful improvement in OS compared to chemotherapy (pemetrexed and cisplatin or carboplatin).

The safety profile of nivolumab plus ipilimumab observed in the trial reflects the known safety profile of the combination.

“Malignant pleural mesothelioma is a devastating disease that has seen limited treatment advances over the past decade,” said Sabine Maier, M.D., development lead, thoracic cancers, Bristol Myers Squibb. “These topline results from the CheckMate -743 trial demonstrate the potential of nivolumab plus ipilimumab in previously untreated patients with malignant pleural mesothelioma, and is another example of the established efficacy and safety of the dual immunotherapy combination seen in multiple tumor types. We would like to thank the patients who participated in this trial, as well as the investigators and site personnel for their perseverance during the conduct of this study and in delivering this important result for patients in the midst of the COVID-19 pandemic. We look forward to working with investigators to present the results at a future medical meeting, and to discussing them with health authorities.”

About CheckMate -743

CheckMate -743 is an open-label, multi-center, randomised Phase 3 trial evaluating nivolumab plus ipilimumab compared to chemotherapy (pemetrexed and cisplatin or carboplatin) in patients with previously untreated malignant pleural mesothelioma (MPM).

Nivolumab is administered at 3 mg/kg every two weeks and ipilimumab at 1 mg/kg every six weeks.

The primary endpoint of the trial was OS. Secondary endpoints included objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and efficacy measures according to PD-L1 expression level.

Source: Bristol Myers Squibb