2020-10-04| Trials & Approvals

FDA Approves Treatment for Aggressive Form of Mesothelioma After Sixteen Long Years

by Rajaneesh K. Gopinath
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By Rajaneesh K. Gopinath, Ph.D.

Mesothelioma, a rare form of cancer, occurs in the mesothelium, a thin membrane that lines the heart, lungs, stomach, and other internal organs. Primarily caused due to asbestos exposure, the symptoms of this condition appear several years later when the cancer is highly malignant. There are four major types of mesothelioma, pleural, peritoneal, pericardial, and testicular. Among them, pleural mesothelioma is the most common, accounting for around 75% of diagnosed cases. Malignant pleural mesothelioma (MPM) is a rare but aggressive cancer associated with poor survival and limited therapies. Traditionally, this condition is treated via surgery, chemotherapy, and radiation. However, several forms of immunotherapies are on the rise.


First FDA-Approved Immunotherapy Regimen

On October 2nd, the U.S. Food and Drug Administration announced the approval of Bristol Myers Squibb’s Opdivo plus Yervoy immunotherapy combo for the first-line treatment of adult patients with unresectable MPM. The approval indicates 360 mg of Opdivo every three weeks, plus 1 mg/kg of Yervoy every six weeks.

With this approval, the combo therapy becomes only the second FDA-approved treatment for mesothelioma and the first in sixteen years. “Today’s approval of nivolumab plus ipilimumab provides a new treatment that has demonstrated an improvement in overall survival for patients with malignant pleural mesothelioma,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “In 2004, FDA approved pemetrexed in combination with cisplatin for this indication, and now patients now have an important, additional treatment option after more than a decade with only one FDA-approved drug regimen.”

The Opdivo, Yervoy regimen is a combination of two immune checkpoint inhibitors that target two different checkpoints to reactivate the immune system. Opdivo (Nivolumab) is a human IgG4 monoclonal antibody that blocks PD-1, while Yervoy (Ipilimumab) is a CTLA-4 targeting monoclonal antibody. The Opdivo plus Yervoy combo has been FDA approved for several indications previously, including metastatic melanoma, metastatic NSCLC, advanced renal cell carcinoma, metastatic colorectal cancer, and hepatocellular carcinoma, among others.


Clinical Trial Data

The approval is an outcome of successful Phase 3 results from CheckMate -743, an open-label, multi-center, randomized trial that compared the drug combo versus chemotherapy in 605 adult patients with unresectable malignant pleural mesothelioma. In the trial, 303 patients received Opdivo (3 mg/kg) every two weeks and Yervoy (1 mg/kg) every six weeks, and the remaining 302 patients received cisplatin (75 mg/m2) or carboplatin AUC 5 plus pemetrexed (500 mg/m2) in 3-week cycles for six cycles.

As compared to chemotherapy, patients who received the drug combo demonstrated superior overall survival, the primary endpoint of the study (Hazard Ratio [HR]: 0.74 [95% Confidence Interval [CI]: 0.61 to 0.89]; P=0.002). While the drug combo arm registered a median overall survival of 18.1 months (95% CI: 16.8 to 21.5), the chemo arm was only 14.1 months (95% CI: 12.5 to 16.2). After two years, around 41% of patients treated with Opdivo plus Yervoy combo were alive as compared to 27% with chemotherapy. Some common serious adverse reactions were pneumonia, pyrexia, diarrhea, pneumonitis, pleural effusion, dyspnea, acute kidney injury, infusion-related reaction, musculoskeletal pain, and pulmonary embolism.

“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,” said study investigator Anne S. Tsao, M.D., Professor and Section Chief Thoracic Medical Oncology at The University of Texas M.D. Anderson Cancer Center.

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