BioCentury
ARTICLE | Clinical News

Monotherapy prospects slip for AZ's durvalumab

December 19, 2015 2:48 AM UTC

AstraZeneca plc (LSE:AZN; NYSE:AZN) said data from the Phase II ATLANTIC trial of durvalumab ( MEDI4736) are "unlikely" to support a regulatory submission of the PD-L1 inhibitor as monotherapy to treat advanced non-small cell lung cancer (NSCLC) in PD-L1 positive patients. The company cited an "evolving" treatment and regulatory landscape in lung cancer, and said it will decide whether to submit durvalumab after it has analyzed the data. AZ had hoped to pursue accelerated approval using data from ATLANTIC.

AZ said a preliminary analysis of ATLANTIC showed durvalumab led to clinical activity and durable responses in NSCLC patients in a third-line or later setting following platinum-based chemotherapy. Spokesperson Karen Birmingham declined to disclose whether the trial met its primary endpoint. AZ plans to report ATLANTIC data next year. ...