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Opdivo plus Yervoy First Immunotherapy Approved for Unresectable Malignant Pleural Mesothelioma

Web Exclusives - FDA Approvals

On October 2, 2020, the FDA approved the combination of nivolumab (Opdivo; Bristol Myers Squibb), a PD-1 inhibitor, and ipilimumab (Yervoy; Bristol Myers Squibb), a CTLA-4 inhibitor, for first-line treatment of adults with unresectable malignant pleural mesothelioma.

“Malignant pleural mesothelioma is a rare cancer with limited treatment options. When it is diagnosed in advanced stages, the 5-year survival rate is approximately 10%,” said study investigator Anne S. Tsao, MD, Professor and Section Chief, Thoracic Medical Oncology, and Director of the Mesothelioma Program at The University of Texas M.D. Anderson Cancer Center, Houston, in a press release. “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.”

This new indication for the immunotherapy combination was based on the results of a prespecified interim analysis of the CheckMate-743 study, a phase 3, randomized, open-label clinical trial in treatment-naïve patients with unresectable malignant pleural mesothelioma. Patients were randomized to the immunotherapy combination (N = 303) or to a chemotherapy combination with cisplatin or carboplatin, plus pemetrexed (Alimta; N = 302).

At a 22-month follow up, the median overall survival was 18.1 months with the immunotherapy combination versus 14.1 months with chemotherapy plus pemetrexed (hazard ratio, 0.74; 95% confidence interval, 0.61-0.89; P = .002). At 2 years, 41% of the patients who received immunotherapy were alive versus 27% of those who received chemotherapy.

The most common (≥20%) adverse reactions with nivolumab plus ipilimumab were fatigue, musculoskeletal pain, rash, diarrhea, dyspnea, nausea, decreased appetite, cough, and pruritus.

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Last modified: February 5, 2021
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