Bavencio receives European positive opinion for treating metastatic Merkel cell carcinoma

The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of Bavencio (avelumab) as a monotherapy for treating adults with metastatic Merkel cell carcinoma, according a news release from Merck KGaA, Darmstadt, Germany, and Pfizer.

The European Commission will review the Committee for Medicinal Products for Human Use (CHMP)'s recommendation for avelumab, a human anti-PD-L1 antibody, with a decision expected in the third quarter of 2017, according to the release.

The FDA granted accelerated approval for avelumab in March 2017 for treating metastatic Merkel cell carcinoma (MCC) in adults and pediatric patients 12 years and older. Avelumab is not approved for any indication in any market outside the US, according to the release.

"We welcome the CHMP’s recommendation, as there are currently no approved treatments in Europe for this type of skin cancer, which can be devastating for patients and their families," Luciano Rossetti, MD, executive vice president, global head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany, stated in the release. "This is an important step towards making avelumab available to patients and we look forward to the European Commission's decision later this year."

The European opinion was based on data from an international, multicenter, single-arm, open-label, phase 2 study split into two parts.

The first part (part A) included 88 patients with metastatic MCC whose disease had progressed after at least one chemotherapy treatment, with 59% of patients having had one prior anti-cancer therapy for metastatic MCC and 41% having two or more prior therapies. There was a minimum of 18 months follow-up.

The second part (part B) of the study, which occurred at time of data cut-off, included 39 patients with histologically confirmed metastatic MCC and were treatment-naïve to systemic treatment. There were 29 patients with at least 13 weeks of follow-up. Enrollment in part B of the study is ongoing, with 112 treatment-naïve patients planned, according to the release.

Avelumab previously received orphan drug designation from the European Commission for MCC, as a medicine intended for “the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating, and has a prevalence in the EU of not more than 5 in 10,000 people,” according to the release.

Reference: www.pfizer.com; www.emdgroup.com/en