FDA approves Opdivo-Yervoy combination for malignant pleural mesothelioma
The FDA approved nivolumab in combination with ipilimumab for the treatment of adults with unresectable malignant pleural mesothelioma, the first drug regimen approved for this population in 16 years.
According to a press release from the FDA, malignant pleural mesothelioma accounts for most mesothelioma diagnoses. Most patients have an unresectable tumor at the time of diagnosis and with the available therapy, OS is generally poor.
“Today’s approval of nivolumab [Opdivo, Bristol Myers Squibb] plus ipilimumab [Yervoy, Bristol Myers Squibb] provides a new treatment that has demonstrated an improvement in overall survival for patients with malignant pleural mesothelioma,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in the press release. “In 2004, FDA approved pemetrexed in combination with cisplatin for this indication, and now patients ... have an important, additional treatment option after more than a decade with only one FDA-approved drug regimen.”
The FDA based this approval, in part, on data from the randomized, open-label phase 3 CheckMate-743 trial, which included 605 patients with previously untreated and unresectable malignant pleural mesothelioma. Patients received 3 mg/kg nivolumab every 2 weeks with 1 mg/kg ipilimumab every 6 weeks for up to 2 years, or platinum-doublet chemotherapy for up to six cycles.
The trial demonstrated that patients receiving nivolumab in combination with ipilimumab survived a median of 18.1 months, whereas patients who underwent chemotherapy survived a median of 14.1 months.
Adverse events associated with the combination included fatigue, musculoskeletal pain, rash, diarrhea, dyspnea, nausea, cough and pruritis. The FDA noted ipilimumab on its own can cause serious immune-mediated side effects.
The FDA conducted this review under Project Orbis in collaboration with the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency, Health Canada and Switzerland’s Swissmedic.