The FDA on Friday approved dual checkpoint blockade with nivolumab (Opdivo) plus ipilimumab (Yervoy) for the first-line treatment of unresectable malignant pleural mesothelioma.
Support for the approval was based on findings from CheckMate 743, an open-label phase III trial that randomized 605 patients with unresectable malignant pleural mesothelioma to either standard platinum-based chemotherapy or the PD-1 inhibitor nivolumab (360 mg every 3 weeks) in combination with the anti-CTLA-4 drug ipilimumab (1 mg/kg every 6 weeks).
“Malignant pleural mesothelioma is a rare cancer with limited treatment options. When it is diagnosed in advanced stages, the five-year survival rate is approximately 10 percent,” said investigator Anne Tsao, MD, of MD Anderson Cancer Center in Houston, in a press release from drugmaker Bristol-Myers Squibb. “The survival results from the CheckMate-743 trial show that the combination of nivolumab and ipilimumab could become a new front-line standard of care option. This is exciting news, instilling