Bristol-Meyers Squibb has received the first drug regimen approved for mesothelioma in 16 years and the second FDA-approved systemic therapy for mesothelioma has gotten U.S. Food and Drug Administration approval.
The combination therapy is Opdivo (nivolumab) and Yervoy (ipilimumab) for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery.
Malignant pleural mesothelioma (MPM) is a life-threatening cancer of the lungs’ lining strongly associated with inhalation of asbestos fibers. MPM accounts for most mesothelioma diagnoses, about 20,000 Americans each year, and most patients have an unresectable (unable to be removed with surgery) tumor at time of diagnosis. Survival is generally poor. Opdivo and Yervoy are both monoclonal antibodies that, when combined, decrease tumor growth by enhancing T-cell function and they were evaluated during a randomized, open-label trial in 605 patients with previously untreated unresectable MPM.
Patients received intravenous infusions of Opdivo every two weeks with intravenous infusions of Yervoy every six weeks for up to two years, or platinum-doublet chemotherapy for up to six cycles. Treatment continued until disease progression, unacceptable toxicity or completion of two years. The objective was to determine if Opdivo in combination with Yervoy improved overall survival compared to chemotherapy. At the time of the analysis, patients who received Opdivo in combination with Yervoy survived a median of 18.1 months while patients who underwent chemotherapy survived a median of 14.1 months.
The most common side effects of Opdivo in combination with Yervoy in patients with MPM include: fatigue, musculoskeletal pain, rash, diarrhea, dyspnea (difficulty breathing), nausea, decreased appetite, cough and pruritis (itching). Yervoy can cause serious conditions known as immune-mediated side effects, including inflammation of healthy organs, such as the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies) and kidneys (nephritis).
