Anti-PD-L1 avelumab under EMA review

Merck KGaA (Xetra:MRK) and Pfizer Inc. (NYSE:PFE) said EMA accepted for review an MAA for avelumab ( MSB0010718C) to treat metastatic Merkel cell carcinoma (MCC), for which there is no approved therapy in the EU.

According to data from the pivotal Phase II JAVELIN Merkel 200 trial, published in The Lancet Oncology, the human IgG1 mAb against PD-L1 led to an ORR of 31.8%, including 8 complete responses and 20 partial responses among 88 evaluable patients who had progressed on chemotherapy. ...