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Yervoy® (Ipilimumab) and Mesothelioma

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Yervoy®, also known as ipilimumab, is an immunotherapy drug. Yervoy® is used to treat melanoma and several other cancers. In 2020, the FDA approved the combination of Yervoy® and Opdivo® as a mesothelioma treatment. Clinical trials are still studying the best ways to use Yervoy® for mesothelioma treatment. This includes testing Yervoy® in combination with other emerging mesothelioma treatments.


01. What Is Yervoy®?

What Is Yervoy®?

Yervoy® is an immunotherapy drug manufactured by Bristol-Myers Squibb. The generic name for Yervoy® is ipilimumab.

Yervoy® is a monoclonal antibody belonging to a class of drugs called immune checkpoint inhibitors. Immune checkpoint inhibitors block a process used by cancer cells to evade the immune system. This process involves interaction between T cells (a type of white blood cell) and cancer cells. When a checkpoint inhibitor blocks the process, it allows the immune system to recognize and attack cancer cells.

In 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy® as a treatment for melanoma. Yervoy® was the first drug to demonstrate improvement in survival for patients with inoperable metastatic melanoma.

Melanoma shares certain characteristics with mesothelioma. For instance, melanoma and mesothelioma have been associated with a BAP1 gene mutation. This mutation increases the risk of a wide range of malignancies that impact the skin, eyes, lining of the chest wall and outer layer of internal organs.

These similarities may have motivated researchers to investigate Yervoy® as a potential treatment option for mesothelioma.

02. Yervoy® and Mesothelioma

How Does Yervoy® Treat Mesothelioma?

Yervoy® is an immunotherapy drug that works by allowing the immune system to attack mesothelioma cancer cells.

Yervoy® is known as a checkpoint inhibitor. This type of therapy helps the immune system recognize cancer cells. Cancer cells may mimic healthy cells in the body, making it difficult for the immune system to recognize them. Yervoy® works by hiding a protein that prevents immune cell response to cancer cells. By hiding this protein, Yervoy® allows immune cells, or T cells, to recognize and attack mesothelioma cells.

Doctors administer Yervoy® through an IV (intravenously) in a clinical setting, such as a cancer center. Treatment generally takes between 30 and 60 minutes per session. The number of sessions may vary depending on an individual’s treatment plan.

Researchers have been testing Yervoy® in clinical trials for mesothelioma. The investigations have observed the efficacy of Yervoy® with different treatment combinations. For instance, a recent clinical trial is testing the efficacy of Yervoy® with and without Opdivo® before surgery.

Many clinical trials have tested the combination of Yervoy® and Opdivo® for mesothelioma. The promising results of these trials led to FDA approval of the combination as a mesothelioma treatment option.

The INITIATE Study

The INITIATE study investigated the use of Yervoy® and Opdivo® in 36 pleural mesothelioma patients. Patients were eligible for the study only if they had experienced mesothelioma progression after chemotherapy treatment. They received treatment for up to two years or until side effects prevented further treatment.

At their three-month follow-ups, 68% of patients experienced disease control. This means their tumors either stopped growing or shrunk. These patients achieved a median survival of 12.7 months.

The MAPS2 Trial

The MAPS2 trial investigated the effects of Opdivo® alone or administered with Yervoy® in pleural mesothelioma patients. Study participants had already been treated with chemotherapy before enrolling. A total of 125 patients were treated. 63 patients received only Opdivo®, while 62 patients received Opdivo® and Yervoy®.

The median survival for each study group was:

  • Opdivo® group: 11.9 months
  • Opdivo® + Yervoy® group: 15.9 months

Opdivo® and Yervoy® for Mesothelioma

Opdivo®, also known as nivolumab, is an immunotherapy drug. Like Yervoy®, it is an immune checkpoint inhibitor. Researchers have been testing the safety and efficacy of Yervoy® and Opdivo® for mesothelioma.

On October 2, 2020, the FDA approved the use of Yervoy® and Opdivo® as a first-line therapy for unresectable pleural mesothelioma. This was the first new FDA approval for a mesothelioma drug or drug combination in 16 years.

The approval came after promising results in clinical trials that showed a survival benefit. In one clinical trial of 605 pleural mesothelioma patients, those treated with the immunotherapy combination had a median survival of 18.1 months. Patients in the study treated with chemotherapy had a median survival of 14.1 months.

The recommended dosage of each drug for pleural mesothelioma is:

  • 360 mg of Opdivo® every three weeks
  • 1 mg/kg of Yervoy® every six weeks

This course can continue for up to two years when disease progression is not evident or until the patient experiences unfavorable toxicity levels.

Opdivo® and Yervoy® for mesothelioma are used in conjunction with two cycles of chemotherapy.

Opdivo® and Yervoy® for Asbestos-Related Lung Cancer

Exposure to asbestos can cause small cell lung cancer and non-small cell lung cancer.

The FDA has approved the use of Opdivo® and Yervoy® in combination as a first-line treatment for metastatic non-small cell lung cancer. The FDA considered efficacy data from the CHECKMATE 227 clinical trial when making their decision.

In the study, patients with non-small cell lung cancer (NSCLC) were treated with one of the following:

  • Chemotherapy
  • Opdivo® and Yervoy®

Patients treated with Opdivo® and Yervoy® achieved a median survival of 17.1 months. Patients treated with chemotherapy achieved a median survival of 13.9 months. Researchers concluded Opdivo® and Yervoy® improved survival for NSCLC patients.

03. Yervoy® Benefits

Yervoy® Benefits

Researchers have concluded that Yervoy® may help extend the life expectancy of mesothelioma patients when combined with other treatments. Clinical trial data supports this conclusion.

Yervoy® + Opdivo® Clinical Trials Show Survival Benefits

INITIATE

Pleural mesothelioma patients who had already undergone chemotherapy were treated with Yervoy® and Opdivo®.

Median Survival Results:

  • Yervoy® and Opdivo®: 12.7 months
MAPS 2

Pleural mesothelioma patients who had already undergone chemotherapy were treated with Yervoy® and Opdivo® or Opdivo® alone.

Median Survival Results:

  • Yervoy® and Opdivo®: 15.9 months
  • Opdivo®: 11.9 months
CHECKMATE 743

Patients with inoperable, untreated pleural mesothelioma were treated with Yervoy® and Opdivo® or chemotherapy.

Median Survival Results:

  • Yervoy® and Opdivo®: 18.1 months
  • Chemotherapy: 14.1 months

Median survival for pleural mesothelioma is about 14 months from diagnosis. Two of the trials above involved patients surviving more than a year after second-line treatment with Yervoy® and Opdivo®. Thus, clinical trials involving Yervoy® for pleural mesothelioma have shown a substantial survival benefit.

Research continues into the efficacy of Yervoy® for mesothelioma, the Opdivo® and Yervoy® regimen, and Yervoy® in combination with other cancer treatments. According to ClinicalTrials.gov, there are currently multiple active clinical trials investigating Yervoy® for the treatment of mesothelioma.

04. Yervoy® Side Effects

Yervoy® Side Effects

As with any medical treatment, the use of Yervoy® for small cell lung cancer, mesothelioma and other malignancies involves a number of potential side effects.

Yervoy® side effects vary with each patient. Patients may experience minimal or short-term side effects, or the side effects may be serious or long-term. Individuals treated with Opdivo® and Yervoy® may experience different side effects than patients treated with Yervoy® alone.

Potential Side Effects of Yervoy® and Opdivo® in Mesothelioma and Lung Cancer Patients

  • Constipation
  • Cough
  • Decreased appetite
  • Diarrhea
  • Dizziness**
  • Difficulty breathing (dyspnea)
  • Fatigue
  • Fever
  • Hair Loss**
  • Headache
  • Itchy Skin
  • Nausea
  • Pain
  • Pneumonia
  • Respiratory infection*
  • Skin rash
  • Swelling
  • Thyroid dysfunction
  • Vomiting
  • Liver inflammation

*These side effects were experienced by mesothelioma patients only.
**These side effects were experienced by lung cancer patients undergoing treatment with Yervoy® and Opdivo®, plus chemotherapy.

Before commencing an Opdivo® and Yervoy® regimen, individuals should discuss all potential side effects with their physician.

05. Yervoy® Eligibility

Who Is Eligible for Yervoy®?

Patients with unresectable pleural mesothelioma may be eligible for the combination treatment of Yervoy® and Opdivo®. Yervoy® is also used to treat other types of cancer, including lung cancer, melanoma, renal cell carcinoma, colorectal cancer and hepatocellular carcinoma.

Patients who are interested in Yervoy® for mesothelioma and asbestos-related diseases should review all treatment options, including the potential risks and benefits, with a licensed physician.

There are a number of active clinical trials involving Yervoy® and cancer. Patients who are interested in joining a Yervoy® clinical trial need to consult with their doctor, as each trial has unique eligibility requirements.

06. Yervoy® Studies

Researchers Continue to Study Yervoy® for Mesothelioma

The Yervoy® and Opdivo® combination therapy is being studied for use as a standardized treatment for mesothelioma patients. Several clinical trials are currently investigating these drugs in combination with other cancer treatments.

Clinical Trial: Yervoy® and Opdivo® + A Novel Antibody

Researchers are investigating the combination of a novel antibody (INCAGN01876) with Yervoy®, Opdivo®, or Yervoy® and Opdivo®. The drugs will be administered to patients with advanced cancers, including mesothelioma.

Clinical Trial: Yervoy® and Opdivo® + a Cancer Vaccine 

Researchers will administer Yervoy® and Opdivo® with a cancer vaccine. This combination treatment will be given to patients with pleural mesothelioma.

Clinical Trial: Yervoy® and Opdivo® Before Surgery 

Researchers will administer Yervoy® and Opdivo® before the patients undergo surgery for pleural mesothelioma. Patients will also receive maintenance Opdivo® for one year following surgery.

Ongoing research into Yervoy® in combination with other treatments may lead to improved survival for mesothelioma patients.

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