The trial dubbed CheckMate -743 saw the Opdivo, Yervoy combination delivered a statistically significant and clinically meaningful improvement in overall survival (OS) compared to chemotherapy comprised of pemetrexed and cisplatin or carboplatin. OS is the primary endpoint of the late-stage trial and was determined on a pre-specified interim analysis conducted by an independent data monitoring committee.
According to Bristol-Myers Squibb, the safety profile of the investigational combination observed in the CheckMate -743 trial was similar to its known safety profile.
In the CheckMate -743 trial, Opdivo is given at 3mg/kg every two weeks and Yervoy administered at 1mg/kg every six weeks. The trial’s secondary endpoints included objective response rate (ORR), progression-free survival (PFS), disease control rate (DCR), and efficacy measures according to PD-L1 expression level.
Malignant pleural mesothelioma is considered to be a rare but aggressive type of cancer that is formed in the lining of the lungs. This type of cancer is most usually caused by exposure to asbestos.
Bristol Myers Squibb thoracic cancers development lead Sabine Maier said: “Malignant pleural mesothelioma is a devastating disease that has seen limited treatment advances over the past decade.
“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.”
The Opdivo, Yervoy combination has approvals to be used in the treatment of unresectable or metastatic melanoma, advanced renal cell carcinoma (RCC), metastatic colorectal cancer, and hepatocellular carcinoma (HCC) across various countries.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor which has been designed to harness the body’s own immune system to help in restoration of the anti-tumor immune response. Yervoy, on the other hand, is a recombinant, human monoclonal antibody that attaches to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4).