Merck, Pfizer receive FDA fast track status for avelumab to treat Merkel cell carcinoma

In September, FDA had granted orphan drug designation for avelumab, to treat MCC, a rare and aggressive type of skin cancer.

Pfizer oncology chief medical officer and clinical development and medical affairs senior vice president Dr. Mace Rothenberg said: "We look forward to working with our partners at Merck KGaA, Darmstadt, Germany, on the development of avelumab in patients with relapsed and refractory Merkel cell carcinoma.

The status is said to relate to the clinical development program for avelumab in metastatic MCC, which comprises Phase II study, Javelin Merkel 200, designed to evaluate the safety and efficacy of avelumab in patients with metastatic MCC who have progressed after at least one prior chemotherapy regimen.

In the trial, the primary endpoint is objective response rate and secondary endpoints comprise of response, progression-free survival, overall survival and safety.

The study, which has enrolled 88 patients, is being carried out in sites across Asia Pacific, Australia, Europe and North America.

Currently, clinical development program for avelumab includes around 1,000 patients, who were treated across more than 15 tumor types, including breast cancer, gastric/gastroesophageal cancer, head and neck cancer, MCC, mesothelioma, melanoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma and urothelial cancer.

Merck and Pfizer collaborated to develop and commercialize avelumab and advance Pfizer’s PD-1 antibody.

In addition, the firms will partner on around 20 high-priority immuno-oncology clinical development programs, including combination trials. Most of the programs will start by the end of this year.