April 20, 2020: “Bristol-Myers Squibb announced that CheckMate -743, a pivotal Phase 3 trial evaluating Opdivo ® (nivolumab) in combination with Yervoy ® (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, 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.
“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 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. 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.”
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 (MPM). 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 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.
Malignant pleural mesothelioma is a rare but aggressive form of cancer that forms in the lining of the lungs. It is most frequently caused by exposure to asbestos. Diagnosis is often delayed, with the majority of patients having advanced or metastatic disease at presentation. Prognosis is generally poor: in previously untreated patients with advanced or metastatic malignant pleural mesothelioma, median survival is less than one year and the five-year survival rate is approximately 10%.”
https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-announces-positive-topline-result-pivotal
