AstraZeneca drops plans to file durvalumab for treatment of head and neck cancers.
AstraZeneca has announced with its Q3 financials, that it was dropping plans to gain an early regulatory review for its checkpoint inhibitor durvalumab in head and neck cancers. The decision comes after the the company announced two weeks ago that the FDA had placed a partial clinical hold on the PD-L1 candidate due to bleeding adverse events in two clinical trials, specifically restricting the company from adding new patients for durvalumab in head and neck squamous cell carcinoma (HNSCC). In a brief update AstraZeneca said: �With recent changes in the HNSCC competitive landscape, including the approval in the U.S. for PD-1 monotherapy for recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy [Merck�s Keytruda], the company is unlikely to make a regulatory submission for this single-arm Phase II trial.�