CheckMate -743, a phase III trial evaluating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) in previously untreated malignant pleural mesothelioma met its primary endpoint of overall survival.
Bristol-Myers Squibb sponsors both drugs.
Based on a prespecified interim analysis conducted by the independent data monitoring committee, Opdivo in combination with Yervoy resulted in a statistically significant and clinically meaningful improvement in OS compared to chemotherapy (pemetrexed and cisplatin or carboplatin).
The safety profile of Opdivo plus Yervoy observed in the trial reflects the known safety profile of the combination.
“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,” Sabine Maier, development lead of Thoracic Cancers at BMS, said in a statement.
CheckMate-743 is an open-label, multi-center, randomized phase III trial evaluating Opdivo plus Yervoy compared to chemotherapy (pemetrexed and cisplatin or carboplatin) in patients with previously untreated malignant pleural mesothelioma. The primary endpoint of the trial was OS. Secondary endpoints included objective response rate, disease control rate, progression-free survival, and efficacy measures according to PD-L1 expression level.
