The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the investigational anti-PD-L1 avelumab for the treatment of metastatic Merkel cell carcinoma (MCC).
The Priority Review status, which is granted to drugs that may provide significant improvements in treatment, or may offer treatment where no adequate treatment exists, will decrease the FDA’s review time from 10 months to six months from the day of filing. If approved, avelumab will become the first treatment approved for metastatic MCC.
“We are pleased the FDA has granted a Priority Review designation for avelumab,” said Luciano Rossetti, MD, executive vice president, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany, said in a press release. “There are currently no approved treatment options for metastatic MCC, and we are committed to working with the FDA to potentially bring the first approved cancer immunotherapy to patients with this aggressive disease,” said Rossetti, whose company operates in the U.S. and Canada as EMD Serono.
Merkel cell carcinoma is a rare and aggressive skin cancer that affects about 1,500 patients each year in the U.S., according to estimates from the American Cancer Society. In relatively low-risk MCC tumors, surgery alone, or surgery combined with radiotherapy, can be sufficient, but in patients with more advanced disease, there is a clear lack of treatment options.
“Metastatic Merkel cell carcinoma is an aggressive disease, and patients face a very poor prognosis, with less than 20 percent surviving beyond five years,” said Chris Boshoff, MD, PhD, senior vice president and head of Immuno-oncology, Early Development and Translational Oncology, Pfizer Global Product Development. “We are encouraged by the results of our Phase II trial and believe avelumab may have potential to be an important treatment option for patients living with this hard-to-treat skin cancer,” Bomhoff said.
The FDA’s Priority Review was based on data from the single-arm, open-label, multi-center Phase 2 JAVELIN Merkel 200 trial (NCT02155647), which was designed to assess the safety and efficacy of avelumab (10 mg/kg every two weeks) in patients with metastatic MCC.
Data presented in June 2016 at the Annual Meeting of the American Society of Clinical Oncology (ASCO), revealed that a subgroup of 61 MCC patients who were unresponsive to prior therapies had an overall response rate of 32%, including six complete responses, 12 partial responses, and seven patients with stable disease.
A study later published in The Lancet Oncology, also provided further insights on avelumab’s safety and effectiveness in the JAVELIN Merkel 200 trial. Among the 88 patients included in the study, 28 (31.8%) were deemed to respond to therapy, with 23 still showing an ongoing response at the time of data cut-off (median follow-up of 10.4 months).
Avemulab already had received FDA Orphan Drug Designation for MCC, as well as Breakthrough Therapy and Fast Track Designations for metastatic MCC.
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