The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Merck and Pfizer’s avelumab to treat patients with metastic Merkel cell carcinoma (MCC) following progression with at least one prior chemotherapy regimen.
Also known as MSB0010718C, velumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody that inhibits PD-L1 interactions to potentially allow the activation of T-cells and the adaptive immune system.
The drug is believed to engage the innate immune system and induce antibody-dependent cell-mediated cytotoxicity (ADCC) by retaining a native Fc-region.
Merck biopharma business research and development global head Dr Luciano Rossetti said: “Metastatic Merkel cell carcinoma is a devastating disease with limited treatment options currently available for patients.
“With this breakthrough therapy designation, we are one step closer to our goal of making a significant difference to patients living with difficult-to-treat cancers, such as metastatic Merkel cell carcinoma, by researching and developing potential new treatment options.”
The breakthrough status is based on the preliminary evaluation of clinical data from the global Phase II study, JAVELIN Merkel 200, which is evaluating the safety and efficacy of avelumab in patients with metastatic MCC whose disease has progressed after at least one prior chemotherapy regimen.
Results from the Phase II trial are planned to be reported at an upcoming scientific congresses in 2016.
Primary objective of the multi-centre, single-arm, open-label Phase II trial is overall response rate and secondary endpoints include duration of response, progression-free survival, overall survival and safety.
A total of 88 patients were enrolled in the trial, which is being conducted in sites across Asia Pacific, Australia, Europe and North America.
Last November, Merck and Pfizer have entered into a strategic alliance to co-develop and co-commercialise avelumab.
Pfizer Oncology Clinical Development and Medical Affairs senior vice-president and chief medical officer Dr Mace Rothenberg said: “In less than two months, the alliance between Merck KGaA, Darmstadt, Germany, and Pfizer has achieved its third regulatory milestone for avelumab, including Orphan Drug designation and Fast Track designation granted in September and October.
“We are very pleased with the progress of the Javelin clinical development programme and we are looking forward to presenting additional data on the potential of this investigational compound in Merkel cell carcinoma and other tumour types in 2016.”
The clinical development programme for avelumab now includes over 1,400 patients who have been treated across more than 15 tumour types.
Image: Very high magnification micrograph of Merkel cell carcinoma. Photo: courtesy of Nephron.