Bristol Myers Squibb’s Opdivo plus Yervoy combination treatment has been approved in the EU for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM).
The European Commission’s (EC) approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) in this patient population is based on data from the CheckMate-743 trial.
This trial met its primary endpoint, with Opdivo plus Yervoy reducing the risk of death by 26% and demonstrating a median overall survival (OS) of 18.1 months versus 14.1 months for platinum-based standard-of-care chemotherapy.
The overall response rate (ORR) was similar across the Opdivo plus Yervoy and chemotherapy arms at 40% and 43% respectively, while duration or response (DoR) was improved with the immunotherapy combination compared to chemotherapy – 11.0 months versus 6.7 months.
Of the patients who responded to BMS’ immunotherapy combination treatment, 32% had ongoing responses at two years, compared to 8% of chemotherapy responders.
The mediant time that patients lived without disease progression or death was 6.8 months with Opdivo plus Yervoy treatment versus 7.2 months with chemotherapy.
“The European Commission’s approval of Opdivo plus Yervoy is a crucial step in addressing the unmet needs of patients with malignant pleural mesothelioma,” said Abderrahim Oukessou, vice president, thoracic cancers development lead, Bristol Myers Squibb.
“In the CheckMate -743 trial, this dual immunotherapy combination demonstrated a clinically meaningful improvement in survival over the standard of care, with 41% of patients who received Opdivo plus Yervoy still alive at two years, compared to only 27% with chemotherapy,” he added.
MPM is a rare and aggressive form of cancer that develops in the lining of the lungs – it is frequently caused by exposure to asbestos.
The prognosis for this type of cancer is typically poor, with previously untreated patients in the advanced or metastatic MPM stages having a median survival rate of between 12 and 14 months and a 10% five-year survival rate.