Today, Bristol Myers Squibb announced new three-year overall survival data from its CheckMate -743 study. These data are based on the clinical trial of nivolumab/ipilimumab combination immunotherapy in mesothelioma. According to the company, 23% of patients treated with the recently FDA-approved treatment combination were alive at 35.5 months (roughly three years) as compared to 15% of patients treated with chemotherapy.
The company also indicated that no new side effects were identified during this additional study period.
The full set of data will be presented this Friday, September 17 at the 2021 European Society for Medical Oncology (ESMO) meeting.
CheckMate-743 is a phase 3 randomized clinical trial evaluating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) in previously untreated patients with malignant pleural mesothelioma. The positive results of the trial led to the FDA approval of the combination immunotherapy for mesothelioma in October of 2020.
Nivolumab is an immunotherapy agent that blocks the PD-1 protein from binding to the PD-L1 protein (also known as immune checkpoint blockade) thus “giving permission” to the immune system to attack the tumor cell. Ipilimumab is a monoclonal antibody and operates in a similar fashion but through a slightly different pathway.
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.