Nasopharyngeal carcinoma: EU approves antibody combined with chemotherapy

Green light from the European Commission to tislelizumab, a monoclonal antibody that, in combination chemotherapy may be used, after approval of individual Member States, for first-line treatment in adult patients with recurrent or metastatic inoperable or not eligible for radiotherapy. announced BeOne Medicines Ltd., a company specializing in oncology. Nasopharyngeal carcinoma is a rare tumor that originates in the nasopharynx, the upper part of the throat behind the nose. In The world has about 133,000 new cases and 80,000 deaths annually. In advanced cases, 5-year survival drops to 49%. Tislelizumab is an IgG4 monoclonal antibody against PD-1 designed to reduce binding to Fcγ receptors, optimizing immune activation against tumor cells. It is already approved in the EU for various malignancies, including adenocarcinomas gastric and esophageal cancer. To date, the drug is approved in 46 countries and has treated over 1.5 million patients worldwide. "The European approval is an important step forward for a difficult disease and often diagnosed at an advanced stage - explains Lisa Licitra, head of Medical Oncology at 3 Tumori of the head and neck, of the National Cancer Institute of Milan - Today we have a new powerful treatment, which does not not only allows to delay the progression of the disease, but that helps patients live longer." The approval, in combination with gemcitabine and cisplatin, is based on the results of the Rationale-309 study, a randomized, double-blind study on 263 patients. The drug has shown significant improvement in progression-free survival, reducing the risk of progression or death. A 12-year follow-up analysis months confirmed the data: the average survival reached 45.3 months in the treated group, compared to 31.8 months in the control. The most common adverse reactions were neutropenia, anemia and thrombocytopenia.