AZ slows durvalumab's development path in SCCHN

AstraZeneca plc (LSE:AZN; NYSE:AZN) said that due to a changing marketplace, it no longer intends to submit regulatory applications for PD-L1 inhibitor durvalumab (MEDI4736) to treat squamous cell carcinoma of the head and neck (SCCHN) based on anticipated data from the ongoing single-arm Phase II HAWK study.

In its 3Q16 earnings report, AstraZeneca said HAWK had been "originally designed as a potential fast-to-market opportunity" for durvalumab monotherapy as a second-line treatment for PD-L1-positive SCCHN patients. AstraZeneca still expects HAWK results to be "available internally" this quarter. In 2015, FDA granted durvalumab Fast Track designation to treat SCCHN...