A phase 3 trial evaluated nivolumab in combination with ipilimumab in patients with previously untreated MPM and successfully met its primary endpoint of overall survival.
Malignant pleural mesothelioma (MPM) is a rare form of cancer that advances aggressively in the lining of the lungs and is commonly caused by exposure to asbestos. Due to the nature of the disease, diagnoses are often made when patients have an advanced or metastatic form of the disease, resulting in a generally poor prognosis. The median survival for untreated patients with advanced or metastatic MPM is less than 1 year and the 5-year survival rate is approximately 10%.1
On April 20, the CheckMate -743 phase 3 trial evaluated nivolumab (Opdivo, Bristol Myers Squibb) in combination with ipilimumab (Yervoy, Bristol Myers Squibb) in patients with previously untreated MPM and successfully met its primary endpoint of overall survival (OS).1
During the trial, researchers evaluated nivolumab and ipilimumab in comparison with the chemotherapy treatments pemetrexed and cisplatin or carboplatin. In order to test each regimen effectively, the researchers administered nivolumab at 3 mg per kg every 2 weeks and ipilimumab at 1 mg per kg every 6 weeks.1
The independent Data Monitoring Committee conducted a pre-specified interim analysis of nivolumab and ipilimumab and found that the results showed a statistically significant and clinically meaningful improvement in OS compared with the chemotherapy treatments.1
The results of the trial also demonstrated that the safety profile of nivolumab and ipilimumab reflect the current known safety profile of the combination.1
These findings are very promising for the treatment of MPM, which is a disease that has seen limited treatment advances over the past decade, said Sabine Maier, MD, development lead, thoracic cancers, Bristol Myers Squibb, in a press release.1
“These topline results from the CheckMate -743 trial demonstrate the potential of nivolumab plus ipilimumab in previously untreated patients with MPM and is another example of the established efficacy and safety of the dual immunotherapy combination seen in multiple tumor types,” Maier said.1