FDA Approves Immunotherapy Combination Treatment for Pleural Mesothelioma

FDA Approves New Pleural Mesothelioma Treatment

The U.S. Food and Drug Administration (FDA) recently announced approval of an immunotherapy treatment combination for mesothelioma. The approval came on October 2, 2020 and is the first approval of this kind in over 15 years.

The treatment combines Opdivo®️ (nivolumab) and Yervoy®️ (ipilimumab). The immunotherapy drugs will be a first-line treatment for pleural mesothelioma patients unable to undergo surgery. The FDA approval came from the treatment’s success in improving patient survival during a large clinical trial.

What Treatment Combination Did the FDA Approve?

The FDA-approved treatment combines nivolumab and ipilimumab. It is a first-line treatment for adults with pleural mesothelioma unable to undergo surgery.

First-line treatment: The first treatment given to a patient and considered the best option for the individual.

Nivolumab and ipilimumab are sold under brand names Opdivo®️ and Yervoy®️, respectively. Both immunotherapy drugs are checkpoint inhibitors. They work together to help the immune system locate, attack and kill cancer cells.

Promising Study Results for Mesothelioma Survival

The FDA approval stems from a successful clinical trial with 605 pleural mesothelioma patients. Researchers looked at patients treated with the immunotherapy combination compared to those treated with chemotherapy.

All patients in the study received no prior treatment. Their disease was also deemed unresectable. In other words, at the time of diagnosis, doctors were unable to remove their tumors with surgery.

Researchers sought to determine which treatment option demonstrated the greatest improvement in survival.

  • First treatment option: Intravenous infusions of Opdivo®️ every two weeks. Intravenous infusions of Yervoy®️ every six weeks.
  • Second treatment option: Cisplatin or carboplatin and pemetrexed (chemotherapy combination) for up to six cycles.

Treatment continued until disease progression, unacceptable toxicity or the two-year mark (whichever came first).

Treatment Comparison Study Results*
Yervoy®️ + Opdivo®️
  • Median survival of 18.1 months
  • 41% of patients alive two years after starting treatment
  • Median survival of 14.1 months
  • 27% of patients alive two years after starting treatment

*Results are from analysis at the minimum 22-month follow-up. 

Similar Studies With Improved Survival

Researchers continue to study the immunotherapy combination in other clinical trials. Some studies focus on patient survival after treatment with only nivolumab compared to nivolumab and ipilimumab.

  • MAPS-2 Study: Median survival improved by four months when treated with both nivolumab and ipilimumab. This is in comparison to treatment with only nivolumab.
  • INITIATE Study: Median survival of greater than 12.7 months for those treated with both nivolumab and ipilimumab.
  • New Study: Researchers will look at survival after treatment with nivolumab and with nivolumab combined with ipilimumab. Patients will then undergo surgery and can continue with chemotherapy or radiation, if appropriate.

Were There Side Effects From the Treatment Combination?

From the study of 605 pleural mesothelioma patients, side effects included:

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

Yervoy®️ could cause other immune-mediated side effects. This includes the inflammation of healthy organs, such as the lungs, colon, liver, endocrine glands or kidneys.

Patients should discuss all current and potential side effects with their medical care team. Palliative options are available to improve patient comfort and quality of life.

What Does the FDA Approval Mean?

Clinical trials offer additional treatment options for patients with cancer unresponsive to traditional therapies. With proven success, these treatments may gain FDA approval. Once approved, the treatments could become widely available to other patients.

Additional details of the FDA approval for pleural mesothelioma: 

  • The FDA granted approval to Bristol Myers Squibb Company.
  • The FDA conducted the review under the Oncology Center of Excellence’s Project Orbis.
  • Under Project Orbis, concurrent reviews took place with health officials from Australia, Brazil, Canada and Switzerland. Other reviews are ongoing.
  • The FDA granted approval around five months ahead of the study’s goal date.

Researchers will continue studying and sharing the results of the immunotherapy treatment combination.

Very few treatment options have FDA approval for mesothelioma. This is only the second systemic therapy approved to treat the cancer. As a result, the new approval could offer hope for many pleural mesothelioma patients.

“The survival results from the CheckMate -743 trial show that the combination of nivolumab and ipilimumab could become a new front-line standard of care option. This is exciting news, instilling hope for patients with this devastating disease and for the healthcare providers who care for them.”

Dr. Anne Tsao (Director of the Mesothelioma Program at The University of Texas M.D. Anderson Cancer Center) from a recent press release

Patients should discuss all treatment options, including clinical trials, with a mesothelioma specialist. Eligibility requirements differ from patient to patient. A specialist will be able to help patients determine which options match their specific case.