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Karen Ritter, RN BSN
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Important Facts About Opdivo and Yervoy for Mesothelioma
- Opdivo and Yervoy are approved as a pair for unresectable malignant pleural mesothelioma. The FDA approved the immunotherapy for mesothelioma in October 2020.
- The drugs are immune checkpoint inhibitors, which means they boost the immune system to recognize cancer cells.
- Opdivo and Yervoy for mesothelioma improve survival rates by four months compared to chemotherapy.
- Side effects are usually mild, but you should report rashes, itchiness or other irritation to your doctor.
FDA Approval of Opdivo and Yervoy for Mesothelioma
The U.S Food and Drug Administration approved Opdivo and Yervoy for unresectable cases of malignant pleural mesothelioma. Unresectable refers to cases where surgery cannot be performed as it won’t help the patient. This usually describes late-stage mesothelioma (stage 3 or stage 4).
The FDA approval came in October 2020, around 17 months after the FDA approved the NovoTTF-100L System tumor treating fields device. The FDA approved the NovoTTF-100L (now called Optune Lua) under the same conditions (unresectable malignant pleural mesothelioma).
In 2021, both Europe and Canada’s health agencies approved Opdivo and Yervoy for malignant mesothelioma. Australia slashed the price of Opdivo and Yervoy from $130,000 to just $41 to make the treatment more accessible for cancer victims.
How Opdivo and Yervoy Work
Opdivo and Yervoy are immunotherapy drugs. They work together to enhance the immune system’s response to cancers like mesothelioma.
More specifically, they are checkpoint inhibitor immunotherapy drugs. They “take the breaks off the immune system,” as many doctors describe, and allow the body’s defenses free reign to attack mesothelioma cells.
The immune system has soldier cells, called T-cells, that kill diseases. These T-cells, unfortunately, have surface proteins. They allow mesothelioma cells to hide from the T-cells.
Opdivo and Yervoy prevent mesothelioma cells from taking advantage of the T-cells.
What Is Opdivo?
Opdivo is the brand name for nivolumab, a generic checkpoint inhibitor immunotherapy drug. Nivolumab is a checkpoint inhibitor for the connection between two proteins, PD-1 and PD-L1. It essentially blocks the link between these proteins.
PD-1 stands for “programmed cell death protein 1.” It’s a protein on T-cells that controls immune response by suppressing T-cell activity.
PD-L1 stands for “programmed death-ligand 1.” It’s a protein on mesothelioma cells that binds with PD-1 to switch off the T-cells. Overexpression of PD-L1 on mesothelioma cells can subdue immune response.
Opdivo is a wall that blocks PD-1 and PD-L1. Keeping the proteins separate initiates a proper immune response when T-cells register mesothelioma cells.
What Is Yervoy?
Yervoy is the brand name for ipilimumab, a generic checkpoint inhibitor immunotherapy drug. Yervoy blocks different proteins than Opdivo does.
Yervoy is a checkpoint inhibitor for CTLA4 and B7. CTLA4 is an immune system T-cell protein receptor and B7 is a mesothelioma protein. Their binding down-regulates the immune system.
Yervoy is a barrier between the two and enhances the T-cells.
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Pleural Mesothelioma Survival With Opdivo and Yervoy
The FDA looks at two factors when approving or rejecting a therapy for a disease: safety and survival. Opdivo plus Yervoy was well-tolerated with hopeful mesothelioma survival rates.
The Checkmate-743 trial included 605 patients. Half received Opdivo/Yervoy and the other half received chemotherapy:
- 18.1 months median survival for Opdivo and Yervoy
- 14.1 months median survival for chemotherapy
- 40.8% two-year survival for Opdivo and Yervoy
- 27% two-year survival for chemotherapy
- 23% three-year survival for Opdivo and Yervoy
- 15% three-year survival for chemotherapy
The immunotherapy arm received Opdivo every two weeks and Yervoy every six weeks.
At the three-year follow-up, Opdivo and Yervoy showed long-term effects against tumors. Patients were “off” the therapy for a year at this point. More than one-quarter of patients were still “in response”, meaning their disease was shrinking. None of the patients receiving chemotherapy were in response this long after treatment stopped.
Peritoneal Mesothelioma Survival with Opdivo and Yervoy
Although Opdivo and Yervoy have not been FDA-approved for peritoneal mesothelioma treatment, doctors at MD Anderson Cancer Center in Houston, Texas conducted a study on 29 advanced peritoneal mesothelioma patients, who are ineligible for surgery, and their responses to Opdivo and Yervoy.
The results showed an overall median survival of 19 months and a one-year survival rate of 68%, which is excellent. For most non-surgical cases of malignant peritoneal mesothelioma, the median survival is 12 months and one-year survival rate of 50%.
Other statistics from the study include:
- 19% response rate (meaning the disease shrank)
- 65% disease control rate (meaning the disease shrank or stalled)
- Median progression-free survival of 5.5 months
- Only one patient experienced toxic side effects from treatment
Side Effects of Opdivo and Yervoy
Safety is often measured in side effects. Chemotherapy’s side effects range from mild fatigue to severe nausea. Chemotherapy also weakens bones and causes neuropathies or nerve damage in extremities.
The side effects of Opdivo and Yervoy are usually much tamer. They include:
- Decreased appetite
- Body aches
The more concerning side effects for Opdivo and Yervoy are difficulty breathing and hormone changes. Doctors may end treatment if patients experience these side effects.
How to Get Opdivo and Yervoy for Mesothelioma
The first step is to go through the medical diagnostic process. This requires testing and a biopsy at a hospital or cancer center.
If your mesothelioma is in an early stage, you might be a candidate for surgery. This is the best option for treatment. If surgery isn’t possible, then you can ask about Opdivo and Yervoy.
Your chances of receiving immunotherapy rise at a mesothelioma cancer center of excellence. These institutions are more likely to offer therapies other than chemotherapy. Some examples include:
- Brigham and Women’s Hospital in Boston
- Baylor St. Luke’s Medical Center in Houston
- Moffitt Cancer Center in Tampa
Frequently Asked Questions About Opdivo and Yervoy for Mesothelioma
Are Opdivo and Yervoy approved for mesothelioma?
Yes, Opdivo and Yervoy are approved by the FDA for malignant pleural mesothelioma. They are allowed for cases ineligible for surgical resection.
How do Opdivo and Yervoy work?
Opdivo and Yervoy are immunotherapy drugs, meaning they strengthen the immune system. They block two proteins from connecting: one on immune system cells and one on mesothelioma cells. This blockade helps the immune system target and kill mesothelioma cells.
What are the survival rates for Opdivo and Yervoy?
Opdivo and Yervoy for mesothelioma together have a median survival of 18 months for unresectable cases. This outperforms chemotherapy by four months. Nearly half of patients survive for at least two years with Opdivo and Yervoy.
Sources & Author
- FDA Approves Drug Combination for Treating Mesothelioma. U.S. Food and Drug Administration. Retrieved from: https://www.fda.gov/news-events/press-announcements/fda-approves-drug-combination-treating-mesothelioma. Accessed: 10/04/2020.
- Nivolumab Plus Ipilimumab Improves OS in Malignant Pleural Mesothelioma. Cancer Network. Retrieved from: https://www.cancernetwork.com/view/nivolumab-plus-ipilimumab-improves-os-in-malignant-pleural-mesothelioma. Accessed: 08/11/2020.
- Checkmate 743 shows that dual immunotherapy, nivolumab + ipilimumab improves overall survival for patients with previously untreated mesothelioma. International Association for the Study of Lung Cancer. Retrieved from: https://www.eurekalert.org/pub_releases/2020-08/iaft-c7s080520.php. Accessed: 08/11/2020.
- Mesothelioma treatment Opdivo and Yervoy’s PBS listing brings hope to hundreds. ABC News. Retrieved from: https://www.abc.net.au/news/2021-06-23/mesothelioma-drug-opdivo-and-yervoy-listed-on-pbs/100237106. Accessed: 06/25/2021.
- Health Canada Approves OPDIVO® (nivolumab) plus YERVOY® (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma. Newswire. Retrieved from: https://www.newswire.ca/news-releases/health-canada-approves-opdivo-r-nivolumab-plus-yervoy-r-ipilimumab-as-the-first-and-only-immunotherapy-treatment-for-previously-untreated-unresectable-malignant-pleural-mesothelioma-837006029.html. Accessed: 06/04/2021.
- Opdivo (nivolumab) Plus Yervoy (ipilimumab) Demonstrates Durable Overall Survival at Three Years Compared to Chemotherapy in First-Line Unresectable Malignant Pleural Mesothelioma in Phase 3 CheckMate -743 Trial. BusinessWire. Retrieved from: https://www.businesswire.com/news/home/20210913005059/en/Opdivo-nivolumab-Plus-Yervoy-ipilimumab-Demonstrates-Durable-Overall-Survival-at-Three-Years-Compared-to-Chemotherapy-in-First-Line-Unresectable-Malignant-Pleural-Mesothelioma-in-Phase-3-CheckMate–743-Trial. Accessed: 09/14/2021.