US FDA approves nivolumab with ipilimumab combination for malignant pleural mesothelioma

US FDA approves nivolumab with ipilimumab combination for malignant pleural mesothelioma

Combinational therapy with nivolumab plus ipilimumab was recently approved by the US FDA for the treatment of adults with unresectable malignant pleural mesothelioma.

Malignant pleural mesothelioma (MPM) is a relatively rare but aggressive form of cancer arising from the membrane covering the lungs and the inner side of the ribs. MPM accounts for most mesothelioma diagnoses. Most patients have an unresectable tumour at the time of diagnosis and with the available therapy, overall survival is generally poor, said the agency.

The approval was given based on the data from the randomised, open-label phase 3 CheckMate-743 trial, which included 605 patients with previously untreated and unresectable MPM. 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, diarrhoea, 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.