The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinion recommending the approval of Merck and Pfizer’s avelumab (BAVENCIO) as a monotherapy to treat adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer.
Merck and Pfizer entered a strategic alliance in November 2014 to jointly develop and commercialise avelumab.
The CHMP recommendation will now be reviewed by the European Commission (EC), which will provide a decision on the approval of the drug in the third quarter of this year.
If approved, avelumab could be the first immunotherapy treatment indicated for mMCC in the European Union (EU).
The positive opinion is based on data from an international, multicentre, single-arm, open-label, Phase II trial (JAVELIN Merkel 200), which is split into two parts.
Merck biopharma business executive vice-president and research and development global head Luciano Rossetti said: “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.
“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 first part of the trial included 88 patients with mMCC whose disease had progressed after at least one chemotherapy treatment, with 59% of patients reported to have had one prior anti-cancer therapy for mMCC and 41% had two or more prior therapies.
At the time of the data cut-off, the trial’s second part included 39 patients with histologically confirmed mMCC who were treatment-naïve to systemic therapy in the metastatic setting, 29 of whom had at least 13 weeks of follow-up.
Enrolment is currently being carried out in the trial’s second part and around 112 treatment-naïve patients are planned to be included.
The EC previously granted orphan drug designation (ODD) for the human anti-PD-L1 antibody, avelumab, for MCC.
Pfizer global product development senior vice president and immuno-oncology, early development, translational oncology head Chris Boshoff said: “Metastatic Merkel cell carcinoma is a devastating disease and patients in Europe currently have very few treatment options.
“This milestone further demonstrates our commitment to tackle hard-to-treat cancers as we continue to explore the potential of avelumab in other tumours.”
In March this year, the US Food and Drug Administration (FDA) granted accelerated approval for avelumab to treat mMCC in adults and paediatric patients aged 12 and older, while the treatment of patients with locally advanced or metastatic urothelial carcinoma was granted approval in May.