EU green light for dual immunotherapy based on nivolumab plus ipilimumab as first-line treatment in adult patients with inoperable malignant pleural mesothelioma (MPM). This was announced by Bristol Myers Squibb (Bms), underlining that the approval of the European Commission is valid for the 27 EU member states, as well as for Iceland, Liechtenstein and Norway. In addition to the European Union – highlights the American company – the combination has been approved in 6 countries including the United States, and further applications for authorization are being reviewed by the world health authorities.
The decision of the European Commission – explains a note – is based on the results of the CheckMate -743 study, the first and only positive phase 3 study on immunotherapy used in the first line in MPM. The trial met its primary endpoint, showing a Superior overall survival with nivolumab plus ipilimumab versus chemotherapy (pemetrexed and cisplatin or carboplatin) in all randomized patients. The safety profile of nivolumab plus ipilimumab in the first line was manageable using the expected protocols for adverse events, and consistent with previous studies conducted in other tumor types with this combination.
Malignant pleural mesothelioma – Bms recalls – 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 (asbestos). Diagnosis is often late, with the majority of patients presenting with an advanced or metastatic tumor. In previously untreated advanced or metastatic MPM patients, the median survival is between 12 and 14 months and the 5-year survival rate is approximately 10%. Now, “after many years of limited progress in the treatment of malignant mesothelioma – says Paul Baas, Department of Thoracic Oncology, Netherlands Cancer Institute and University of Leiden – we have found an important clinical benefit for patients with the combination of nivolumab and ipilimumab in the CheckMate study -743 “.
“With the European Commission’s approval of this dual immunotherapy-based association – adds Baas – patients and doctors will now have a new treatment option that has shown significant survival improvements for the management of this resistant disease”.
“The 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, member of the Board 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 fewer 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 “.
“The approval by the European Commission of the nivolumab and ipilimumab association represents a fundamental step to address the unmet needs of patients with malignant pleural mesothelioma – said Abderrahim Oukessou, vice president, thoracic cancers development lead, Bms – In the CheckMate -743 study this association based on dual immunotherapy demonstrated a clinically significant improvement in survival over standard of care, with 41% of patients treated with nivolumab and ipilimumab still alive at 2 years, compared with 27% with chemotherapy. We thank the patients and investigators involved. in the study, whose contribution was essential to offer the first immunotherapy option to mesothelioma patients across the European Union. “