Bristol Myers Squibb announced today that CheckMate -743, a pivotal phase 3 trial evaluating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) in previously untreated malignant pleural mesothelioma, met its primary endpoint of overall survival. The trial resulted in a statistically significant and clinically meaningful improvement in overall survival compared to chemotherapy (pemetrexed and cisplatin or carboplatin), based on a pre-specified interim analysis conducted by the independent Data Monitoring Committee.
“This is very encouraging news. Phase 3 testing in a randomized setting provides the most robust data that can lead to expedited approval,” said Mary Hesdorffer, NP, executive director of the Mesothelioma Applied Research Foundation. “We are anxiously awaiting completion of the trial and data analysis.”
More about the trial
CheckMate -743 is an open-label, multi-center, randomized Phase 3 trial evaluating Opdivo plus Yervoy compared to chemotherapy (pemetrexed and cisplatin or carboplatin) in patients with previously untreated malignant pleural mesothelioma. Opdivo is administered at 3 mg/kg every two weeks and Yervoy at 1 mg/kg every six weeks. The primary endpoint of the trial was overall survival. Secondary endpoints included objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and efficacy measures according to PD-L1 expression level.
“These topline results from the CheckMate -743 trial demonstrate the potential of Opdivo plus Yervoy 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,” said Sabine Maier, MD, development lead, thoracic cancers, Bristol Myers Squibb.
The Mesothelioma Applied Research Foundation is the only 501(c)(3) nonprofit organization working to eradicate mesothelioma and end this national tragedy. Its programs include the funding of promising and peer-reviewed research, education, support and advocacy. The organization strives to bring together thought-leaders in the field to identify the most direct path to a cure.
