EMA validates the MAA for avelumab for the treatment of metastatic Merkel cell carcinoma

If approved, avelumab, an investigational anti-PD-L1 IgG1, could be the first treatment indicated for patients with metastatic Merkel cell carcinoma.

“While early-stage MCC can be generally managed with surgery, there are significant unmet needs in metastatic disease, where treatment options are severely limited,” said Luciano Rossetti, Executive Vice President, Global Head of Research & Development at the biopharma business of Merck. “We are pleased that the EMA is initiating its review of avelumab, as this means we are one step closer to bringing a much-needed new treatment option to European patients.”

“This is the first of what we hope will be many regulatory milestones for avelumab,” said Chris Boshoff, Senior Vice President and Head of immuno-oncology, early development and translational oncology, Pfizer Global Product Development. “We are committed to evaluating avelumab in a number of hard-to-treat cancers, and we believe it may have potential to be an important treatment option for patients with metastatic MCC.”

The avelumab metastatic MCC MAA submission is supported by data from JAVELIN Merkel 200, a multicenter, single-arm, open-label, Phase II study of 88 patients with metastatic MCC whose disease had progressed after at least one chemotherapy treatment. The JAVELIN Merkel 200 study represents the largest data set of any anti-PD-L1/PD-1 antibody reported in this patient population. These data were recently published in the Lancet Oncology.

The clinical development program for avelumab, known as JAVELIN, involves at least 30 clinical programs and over 2,900 patients evaluated across more than 15 different tumour types. In addition to metastatic MCC, these cancers include breast, gastric/gastro-esophageal junction, head and neck, Hodgkin’s lymphoma, melanoma, mesothelioma, non-small cell lung, ovarian, renal cell carcinoma and urothelial (primarily bladder).