Merck KGaA and Pfizer announced Thursday that the European Commission authorised Bavencio (avelumab) as a monotherapy for the treatment of adults with metastatic Merkel cell carcinoma (mMCC). The companies noted that the anti-PD-L1 antibody is the first approved immunotherapy for the condition in the EU, with initial launches planned in Germany and the UK as early as next month.
According to Merck and Pfizer, approval of Bavencio, which follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in July, is based on data from the mid-stage JAVELIN Merkel 200 study. In the first part of the trial, which included 88 patients with mMCC whose disease had progressed after at least one chemotherapy treatment, the objective response rate was 33 percent, with 11 percent of patients experiencing a complete response.
Meanwhile, in the second part of the trial, which included 39 patients with histologically confirmed mMCC who were treatment-naïve to systemic therapy in the metastatic setting, the objective response rate was 62 percent, with 14 percent of patients experiencing a complete response.
In March, Bavencio gained accelerated approval from the FDA for the treatment of adults and children aged 12 and older with mMCC. The therapy was later cleared by the agency for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy.
Merck and Pfizer are also studying Bavencio across more than 15 different tumour types, including breast, gastric/gastro-esophageal junction, head and neck, Hodgkin's lymphoma, melanoma, mesothelioma, non-small cell-lung, ovarian and renal cell carcinoma.
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