Green light from the European Commission for the molecule pair nivolumab and ipilimumab for the first-line treatment of adult patients with inoperable malignant pleural mesothelioma. The combination of immunotherapies thus obtains its fourth indication for advanced cancer: mesothelioma, non-small cell lung cancer, melanoma and renal cell carcinoma. The decision is based on the results of the first and only positive Phase 3 study of a first-line immunotherapy in malignant pleural mesothelioma. The results showed that overall survival was superior with nivolumab plus ipilimumab compared to chemotherapy in all randomized patients. Increased efficacy associated with a manageable safety profile using the expected protocols for adverse events and in line with previous studies conducted in other tumor types with this association. “After many years of limited progress in the treatment of malignant mesothelioma, we have found an important clinical benefit for patients with the combination of nivolumab and ipilimumab in the CheckMate -743 study,” says Paul Baas, MD, Ph.D., Department of Thoracic Oncology, Netherlands Cancer Institute and Leiden University. “With the European Commission approval of this dual immunotherapy-based association, patients and clinicians will now have a new treatment option that has shown significant survival improvements for the management of this resistant disease.”
The decision of the European Commission allows the use of nivolumab plus ipilimumab in the first line in inoperable malignant pleural mesothelioma in the 27 member states of the European Union, as well as in Iceland, Liechtenstein and Norway. In addition to the European Union, the combination has been approved in six countries, including the United States, and further authorization applications are under review by world health authorities. “Diagnosis of mesothelioma can be devastating for patients and their families, and the disease has a significant impact in Europe, which has the highest incidence rate of mesothelioma globally,” said Stefania Vallone, Board Member of Women Against. Lung Cancer in Europe. “Mesothelioma is often diagnosed decades after exposure to asbestos, and for years these patients have dealt with this aggressive cancer with few treatment options. We are delighted to see a new therapy approved that can offer patients and their families the hope of a longer life. Our hope is that it will soon be available in all European countries ”.
Malignant pleural mesothelioma
Malignant pleural mesothelioma is a rare but aggressive form of cancer that develops on the surface of the lungs. It is most frequently caused by exposure to asbestos. Diagnosis is often late, with the majority of patients presenting with advanced or metastatic disease. The prognosis is generally poor: in previously untreated patients with advanced or metastatic malignant pleural mesothelioma, the median survival is between 12 and 14 months and the five-year survival rate is approximately 10%.
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