EMA validates filing for Merck KGaA, Pfizer's anti-PD-L1 therapy avelumab in metastatic Merkel cell carcinoma

Merck KGaA and Pfizer on Monday announced that the European Medicines Agency validated a submission seeking approval of the investigational therapy avelumab for the treatment of metastatic Merkel cell carcinoma (MCC). The drugmakers noted that if approved, the fully human anti-PD-L1 monoclonal antibody, also known as MSB0010718C, would be the first authorised treatment for metastatic MCC in Europe.

According to Merck and Pfizer, the submission is supported by safety and efficacy data from the mid-stage JAVELIN Merkel 200 study, which involved 88 patients with metastatic MCC whose disease had progressed after at least one chemotherapy treatment. Results released in June showed that avelumab was associated with an overall response rate of 31.8 percent in previously treated patients with metastatic MCC, as well as a manageable safety profile.

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"This is the first of what we hope will be many regulatory milestones for avelumab," remarked Chris Boshoff, head of immuno-oncology, early development and translational oncology at Pfizer Global Product Development, adding "we are committed to evaluating avelumab in a number of hard-to-treat cancers."

In 2014, Pfizer paid Merck $850 million upfront as part of an agreement potentially worth more than $2.8 billion to jointly develop and market avelumab for multiple cancer indications. Meanwhile, Merck has pledged to increase investments in avelumab, which was awarded orphan drug designation by the EMA last year for MCC, with the German company forecasting sales of approximately 2 billion euros ($2.2 billion) for the medicine and other drugs in its pipeline by 2022.

Meanwhile, US regulators have also granted orphan drug, fast track and breakthrough therapy designations to avelumab for the treatment of metastatic MCC.

Avelumab is being studied for a number of other cancers, including breast, gastric/gastro-esophageal junction, head and neck, Hodgkin's lymphoma, melanoma, mesothelioma, non-small-cell lung, ovarian, renal cell carcinoma and urothelial.

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