The U.S. Food and Drug Administration recently approved a medical device, NovoTTF-100L System, for treating mesothelioma. The acceptance of the tumor treating fields device was the first approval in 15 years.
Here’s to hoping the next one doesn’t take nearly as long — and recent international news suggests it won’t.
Ono Pharmaceutical announced in August 2018 that the company received approval in Japan to use nivolumab (brand name “Opdivo”) for pleural mesothelioma treatment in specific cases. Then, just weeks ago, Clinical Cancer Research published the results of a MERIT study that led to Japan’s approval of the immunotherapy.
With Japan taking this action, could the U.S. follow with another FDA-approved option for mesothelioma patients?
How Nivolumab Works
Nivolumab is an immunotherapy, meaning it helps the body’s immune system. The medication is part of a group of immunotherapy drugs called immune checkpoint inhibitors, or antibodies. In short, nivolumab disrupts whatever biological phenomenon opposes the immune system’s ability to protect your health.
Nivolumab is specifically a PD-1 inhibitor. PD-1 (an acronym for “programmed death”) is a checkpoint protein on T-cells, which are the primary immune system defense within your body. When they work effectively, T-cells recognize and kill virus-infected cells, keeping you healthy. PD-1 is an unofficial “off switch;” it identifies healthy cells that the T-cell should ignore.
However, mesothelioma is a cancer and often includes high levels of another protein, PD-L1. When the T-cells interact with the cancerous cells, the PD-1 protein can bind to PD-L1. This process activates the PD1, which tells the T-cells to ignore the cancerous cells. The result? Mesothelioma cells are masked and allowed to continue growing and spreading within the body.
Nivolumab targets the PD-1 and PD-L1 connection specifically. By doing so, the proteins cannot bind and will not hamper your immune system’s ability to identify intruders. The immune system then recognizes cancerous cells as dangerous intruders and attacks them.
Study Leading to Japan’s Approval for Mesothelioma
The nivolumab study used for approval in Japan involved 34 participants. The researchers hoped to find a viable option for mesothelioma patients who were not candidates for surgery and did not have success using chemotherapy.
The patients enrolled in the study between July 2016 and October 2016. They received 240 milligrams of nivolumab every two weeks until there was “progressive disease or unacceptable toxicity,” according to the report on the U.S. National Library of Medicine website.
Ten of the 34 participants showed a “centrally assessed objective response” to using nivolumab for their pleural mesothelioma. This result indicates a positive result, meaning the antibody stopped the PD-1 and PD-L1 binding and helped the immune system attack the tumors.
The disease control rate was 68%, meaning that percentage of patients (or 23 of the 34 participants) saw their tumors either stagnate in size or decrease. The median overall survival for the patients was around 17.3 months, which is a longer life expectancy for many people with pleural mesothelioma.
Researchers feel they met the goals for the study and could use nivolumab as “second- or third-line treatment” for pleural mesothelioma patients. They said the drug “showed promising efficacy with manageable toxicity.”
Nivolumab Clinical Trial in the United States
Baylor College of Medicine’s Lung Institute recently announced on its website a new clinical trial involving nivolumab. Researchers plan to pair the immunotherapy with a new drug, an adenovirus called MTG201.
Nivolumab will target the PD-1 and PD-L1 relationship, keeping the immune system activated. The adenovirus causes a quicker cancer cell death, too, as it releases tumor antigens that inspire the nivolumab to directly attack the disease.
“This therapy eradicates mouse mesothelioma tumors, rapidly and consistently in an aggressive mouse model of mesothelioma,” said Dr. Bryan Burt, the trial’s lead investigator.
According to the U.S. National Library of Medicine’s clinical trials database, the study will involve 12 participants who have pleural mesothelioma and did not respond well to chemotherapy. The study is further proof of nivolumab’s potential as a pleural mesothelioma treatment in the United States.
The FDA Approval Process for Mesothelioma
Nivolumab is already approved in the U.S. for numerous diseases, including melanoma and some non-small cell and small cell lung cancers. Therefore, the FDA is aware of its benefits.
The lingering question is whether nivolumab would pass the FDA’s approval process. When the FDA approved NovoTTF-100L, the manufacturer had to go through the medical device approval process. According to the website Registrar Corp, this procedure is less arduous than the one for drugs. Most medical devices don’t need the FDA’s approval before entering the consumer market.
For drugs, especially ones that don’t meet the qualifications for being an over-the-counter option, they must pass a series of clinical tests. The FDA reviews the results of these trials and determines if the benefits of using the treatment outweigh the risks. In many cases for mesothelioma medication, the risks are considerable due to the aggressive nature of the drugs in combating the cancer. This high-risk aspect is why many treatment combinations, immunotherapy drugs and other experimental methods do not receive FDA approval.
If you’d like to help nivolumab get U.S. approval for mesothelioma treatment, consider joining a clinical trial. You can even join a study that involves another drug or treatment option for mesothelioma patients. Not only do you receive cutting-edge treatment for your disease, but you could also help save the lives of future generations.
Karen Ritter is our registered nurse, patient advocate and an excellent resource for all mesothelioma patients. She can help you find a clinical trial that suits your disease and where you live. Email her at email@example.com for information on the studies still accepting participants.
- Opdivo Approved for Supplemental Applications for Expanded Indications of Malignant Pleural Mesothelioma and Adjuvant Treatment of Melanoma, Change in Dosage and Administration (D&A) of Single Dosing Regimen, and Expanded Indication of Renal Cell Carcinoma in Opdivo and Yervoy Combination Therapy. Ono Pharmaceutical Co. Retrieved from: https://www.ono.co.jp/eng/news/pdf/sm_cn180821.pdf. Accessed: 07/19/19.
- Immune checkpoint inhibitors to treat cancer. American Cancer Society. Retrieved from: https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/immune-checkpoint-inhibitors.html. Accessed: 07/19/19.
- How Does OPDIVO® Work With My Immune System?. Opdivo. Retrieved from: https://www.opdivo.com/about-opdivo/how-opdivo-works. Accessed: 07/19/19.
- How to Get FDA Approval. Registrar Corp. Retrieved from: https://www.registrarcorp.com/how-to-get-fda-approval/. Accessed: 07/22/19.
- Clinical Trial uses immunotherapy to treat mesothelioma. Baylor College of Medicine. Retrieved from: https://www.bcm.edu/news/cancer/clinical-trial-immunotherapy-mesothelioma. Accessed: 07/29/19.
- MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma. U.S. National Library of Medicine. Retrieved from: https://clinicaltrials.gov/ct2/show/NCT04013334?term=04013334&recrs=ab&rank=1. Accessed: 07/29/19.
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