FDA approves Opdivo and Yervoy combination for malignant pleural mesothelioma treatment

Bristol Myers Squibb (BMS) has secured approval from the US Food and Drug Administration (FDA) for a new combination treatment involving Opdivo (nivolumab) and Yervoy (ipilimumab) for the first-line treatment of unresectable malignant pleural mesothelioma (MPM). This breakthrough approval is a significant advancement in the fight against this rare and aggressive form of cancer.

Opdivo and Yervoy Combination: A New Era for MPM Treatment

The FDA approval specifically authorizes the combination of Opdivo, administered at 360 mg every three weeks, and Yervoy, given at 1 mg/kg every six weeks, as a treatment option for adults diagnosed with unresectable malignant pleural mesothelioma. The treatment involves intravenous injections, offering a new hope for patients facing this life-threatening disease.

Malignant pleural mesothelioma, a cancer that affects the lining of the lungs, is strongly linked to asbestos exposure. This condition remains challenging to treat, with the prognosis for many patients being dire. The approval of Opdivo and Yervoy represents a groundbreaking shift in treatment strategies, offering patients a novel therapy after years of limited options.

FDA’s Endorsement of a Promising Treatment Option

Richard Pazdur, the director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases, highlighted the significance of this approval. He emphasized that the combination of nivolumab and ipilimumab has shown an improvement in overall survival for MPM patients. In his statement, Pazdur pointed out that the approval marks a major step forward in providing a new treatment option for patients with malignant pleural mesothelioma after more than a decade of relying on a single FDA-approved drug regimen.

In 2004, the FDA approved pemetrexed in combination with cisplatin as a treatment for MPM, making it the only approved regimen for the disease until now. With the introduction of Opdivo and Yervoy, patients now have a critical additional option to consider, potentially improving their quality of life and extending survival.

Clinical Trial Results: Opdivo and Yervoy Outperform Traditional Chemotherapy

The approval was largely driven by the results from the CheckMate -743 study, a phase 3 clinical trial involving 605 patients with untreated, unresectable malignant pleural mesothelioma. The trial demonstrated that the Opdivo and Yervoy combination provided superior overall survival compared to the platinum-based chemotherapy regimen, which is the current standard of care for MPM.

The median overall survival (OS) for patients treated with Opdivo and Yervoy was 18.1 months, compared to just 14.1 months for those receiving chemotherapy. The follow-up period, which lasted for a minimum of 22.1 months, revealed even more promising results. At the two-year mark, 41% of patients on the Opdivo + Yervoy combination were still alive, compared to only 27% of those on chemotherapy.

These findings underscore the potential of this immunotherapy combination to provide patients with a significantly better chance at survival and improved outcomes, marking a critical milestone in the treatment of MPM.

Opdivo and Yervoy: A Key Tool in the Fight Against Thoracic Cancers

Opdivo and Yervoy have already proven their worth in treating various thoracic cancers, including non-small cell lung cancer (NSCLC). The recent approval for MPM marks the third indication for this combination in thoracic cancers and the seventh overall. With this new approval, Opdivo and Yervoy are poised to become a cornerstone in the treatment of previously untreated unresectable MPM.

Adam Lenkowsky, the general manager and head of U.S. Oncology, Immunology, and Cardiovascular at Bristol Myers Squibb, expressed his optimism about the future of the treatment. He noted that thoracic cancers are particularly complex and challenging, and BMS is committed to developing immunotherapy options that could extend patients’ lives. Lenkowsky also pointed out that this approval is especially significant as it represents the first new systemic therapy for MPM in more than 15 years, giving patients a fresh opportunity for extended survival.

A Significant Advancement for Malignant Pleural Mesothelioma Treatment

The approval of the Opdivo and Yervoy combination therapy for the treatment of unresectable malignant pleural mesothelioma is a monumental development in oncology. It offers a promising new option for patients with this aggressive cancer, demonstrating the continued progress in the field of immunotherapy and cancer treatment. With the backing of robust clinical trial results, this combination could transform the landscape of MPM treatment and improve outcomes for patients who have long had limited therapeutic choices.