The FDA has approved a new drug combination for mesothelioma. It is the first systemic treatment for mesothelioma to win FDA approval in 16 years.
The combination includes a pair of immunotherapy drugs that complement each other. Both drugs are immune checkpoint inhibitors. They are approved to treat people with inoperable pleural mesothelioma.
“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,” says Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence.
New Treatment Options Needed
Pleural mesothelioma is a virulent cancer of the membrane that surrounds the lungs. Asbestos exposure is usually the trigger. Many countries have banned asbestos. In the US, asbestos is heavily regulated. Even so, about 2,500 Americans get mesothelioma every year.
The new drug combination for mesothelioma marks the first new medication for mesothelioma since 2004. That is when Alimta (pemetrexed) became the first-ever mesothelioma drug.
Alimta was not a cure but it was a breakthrough. Until it’s approval, mesothelioma patients had no good treatment options.
Today, most mesothelioma patients get chemotherapy with Alimta. It helps about 40 percent of mesothelioma patients live longer than they otherwise would. Doctors hope the new drug combination for mesothelioma will extend survival for more people.
Yervoy and Opdivo: The New Drug Combination for Mesothelioma
The newly-approved treatment combines Opdivo (nivolumab) and Yervoy (ipilimumab). Opdivo and Yervoy are both monoclonal antibodies. Yervoy helps activate and proliferate T-cells. Opdivo helps existing T-cells discover the tumor. Together, they slow down mesothelioma tumor growth.
The FDA approved the new drug combination for mesothelioma based on the results of a clinical trial. The trial included 605 patients with unresectable pleural mesothelioma. Patients received infusions of Opdivo every two weeks. Some patients also got Yervoy every six weeks. Others had up to six cycles of chemotherapy.
The patients who got the new drug combination for mesothelioma lived a median of 18 months. The patients who had Opdivo and chemotherapy survived for about 14 months. At one year, almost 70 percent of patients who got the immunotherapy drugs were still alive. Only 58 percent of chemotherapy patients lived that long.
Treatment May Be Especially Helpful for Non-Epithelioid Mesothelioma
Most mesothelioma patients have the epithelioid subtype. These patients tend to respond best to treatment. But the new drug combination for mesothelioma was especially helpful for patients with a non-epithelioid subtype.
The trial showed these patients lived a median of just 8 months on chemotherapy. The lead investigator said the new regimen “should be considered as a new standard of care” for patients with non-epithelioid mesothelioma.
An electronic device called Tumor Treating Fields is the only other approved treatment for mesothelioma. Bristol-Myers-Squibb received FDA approval for the Yervoy/Opdivo combo five months ahead of the goal date.
“FDA Approves Drug Combination for Treating Mesothelioma”, FDA Press Announcement, October 2, 2020
“Opdivo (nivolumab) Plus Yervoy (ipilimumab) Demonstrates Durable Survival Benefit vs. Chemotherapy in Patients with Previously Untreated Malignant Pleural Mesothelioma”, Bristol Myers Squibb, Press Release, August 8, 2020, https://news.bms.com/press-release/corporatefinancial-news/opdivo-nivolumab-plus-yervoy-ipilimumab-demonstrates-durable-s
Fowler, Matthew, “Nivolumab Plus Ipilimumab Improves OS in Malignant Pleural Mesothelioma”, August 10, 2020, Cancer Network, https://www.cancernetwork.com/view/nivolumab-plus-ipilimumab-improves-os-in-malignant-pleural-mesothelioma