FDA Approves First Immunotherapy Drug Combination for Mesothelioma

Recently, the U.S. Food and Drug Administration (FDA) approved a combination of immunotherapy drugs for the treatment of pleural mesothelioma. The approval was announced on October 2, 2020 and is the first drug treatment regimen of its kind in 16 years.

This is big news for the mesothelioma community, as it gives patients an additional option for treating their rare and aggressive disease. 

The FDA has specifically approved this treatment for patients with malignant pleural mesothelioma that cannot undergo surgery. The drugs Opdivo (nivolumab) and Yervoy (ipilimumab) are both used successfully on their own to treat other cancers, however, when used together in mesothelioma, have shown effective results in recent phase three clinical trials. 

Mesothelioma patients have always faced limited treatment options, especially if they weren’t surgical candidates. Fortunately, this is not the only treatment that has recently been approved for this type of cancer. In 2019, the FDA approved NovoTTF-100L (rebranded to Optune Lua), a tumor treating field device used in combination with chemotherapy to treat unresectable pleural mesothelioma. 

Even with current available treatment options, overall survival rates for malignant pleural mesothelioma are generally poor. While surgery is the most effective way to treat mesothelioma, most patients aren’t eligible. This immunotherapy drug combination could extend patients’ survival rates by months.

How Does An Immunotherapy Drug Combination Help Survival Rates?

Approval for this drug combination comes after a successful clinical trial with 605 pleural mesothelioma patients. The main goal of the clinical trial was to determine if the immunotherapy combination improved overall survival rates compared to chemotherapy.

Patients who took part in the study received no prior treatments. Their disease was also considered unresectable at the time of their diagnosis. This means that doctors were not able to remove any of their tumors with surgery. 

When combined, Opdivo and Yervoy were able to decrease tumor growth by enhancing T-cell function allowing a patient’s own immune system to recognize and kill cancer cells. To determine which treatment option demonstrated greatest survival, participants were given two options:

• Intravenous infusions of Opdivo every two weeks and Yervoy every six weeks
• A mix of chemotherapy drugs which included Cisplatin (or carboplatin) and pemetrexed

These treatments were given for two years unless disease progression occurred or there was an unacceptable toxicity.

The study found that with the combination of Opdivo and Yervoy there was a median survival rate of 18.1 months with 41% of patients still being alive after two years. 

When given chemotherapy treatment, the patients survival rate was 14.1 months with only 27% still alive after two years of starting treatment.

Were There Any Side Effects?

From the 605 participants in the study, the most common side effects of Opdivo and Yervoy included:

• Fatigue                                                            
• Musculoskeletal pain
• Rash 
• Diarrhea
• Difficulty breathing
• Nausea
• Itching 
• Cough
• Decreased Appetite 

Compared to the more severe effects of chemotherapy, the side effects of the immunotherapy drugs were deemed manageable and mild. 

Patients should consult with their mesothelioma specialist about their available treatment options and any clinical trials they may qualify for. Each case is unique and not all patients may be eligible for the same type of treatment plan. 

While there is no cure for mesothelioma, many patients can expect to see an overall improvement with their prognosis and life expectancy after beginning this immunotherapy drug regimen.