Patients who received the combination of nivolumab and ipilimumab survived a median of 18.1 months, while patients who underwent chemotherapy survived a median of 14.1 months.
The US Food and Drug Administration (FDA) has approved the first new drug for mesothelioma in 16 years, giving the green light to a combination of nivolumab (Opdivo) and ipilimumab (Yervoy).
The approval is earmarked as a first-line treatment of adults with malignant pleural mesothelioma (MPM) that cannot be removed by surgery. Both parts of the combination therapy are monoclonal antibodies that decrease tumor growth by enhancing T-cell function when combined.
The approval was based on a randomized, open-label trial involving 605 patients with previously untreated unresectable MPM. In the study patients received intravenous infusions of nivolumab every 2 weeks with intravenous infusions of ipilimumab every 6 weeks for up to 2 years or platinum-doublet chemotherapy for up to 6 cycles.
At the time of the analysis, patients who received the combination drug survived a median of 18.1 months, while patients who underwent chemotherapy survived a median of 14.1 months.
The most common side effects include fatigue, musculoskeletal pain, rash, diarrhea, dyspnea, nausea, decreased appetite, cough, and pruritis.Ipilimumab is known to cause immune-mediated side effects, including inflammation of health organs such as the lungs, colon, liver, endocrine glands, and kidneys.
MPM is a life-threatening cancer in the lining of the lungs caused by inhaling asbestos fibers. Around 20,000 individuals in the US are diagnosed each year. MPM accounts for most mesothelioma diagnoses, while the majority of patients have unresectable tumor at the time of diagnosis. The overall survival is generally poor with the current available therapy.
"Today's approval of nivolumab plus ipilimumab 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 a statement. "In 2004, FDA approved pemetrexed in combination with cisplatin for this indication, and now patients now have an important, additional treatment option after more than a decade with only one FDA-approved drug regimen."