One step closer to the treatment of Merkel cell carcinoma18 Nov 2015
The US Food and Drug Administration (FDA) has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, breakthrough therapy designation for the treatment of patients with metastatic Merkel cell carcinoma (MCC) who have progressed after at least one previous chemotherapy regimen.
Breakthrough therapy designation is designed to accelerate the development and review of medicines that are intended to treat a serious condition. Merkel cell carcinoma is a rare and aggressive type of skin cancer and currently there is no therapy approved.
Preliminary data of a phase 2 global clinical study
The breakthrough therapy designation is based on the preliminary evaluation of clinical data from the global Phase 2 study, JAVELIN Merkel 200, which is assessing the safety and efficacy of avelumab in patients with metastatic Merkel cell carcinoma whose disease has progressed after at least one prior chemotherapy regimen.
JAVELIN Merkel 200 is a multicenter, single-arm, open-label Phase 2 study with a primary objective of overall response rate. Secondary endpoints include duration of response, progression-free survival, overall survival and safety. The study enrolled 88 patients and it is being conducted in sites across Asia Pacific, Australia, Europe and North America.
Source: eCancer News