FDA Places Clinical Hold on Head and Neck Cancer Drug Trial
Durvalumab trial halted in head and neck squamous cell carcinoma patients due to bleeding events.
AstraZeneca recently announced that the FDA placed a partial clinical hold on enrolling new patients in clinical trials of durvalumab.
The company is no longer allowed to enroll patients with head and neck squamous cell carcinomas in studies investigating the drug alone, in combination with tremelimumab, or other drugs.
However, AstraZeneca said in a press release that all ongoing trials will continue without enrolling additional patients. The clinical hold only applied to head and neck squamous cell carcinoma, and they will enroll new patients with different cancers as anticipated.
Durvalumab is an investigational human monoclonal antibody against programmed death ligand-1 that can assist tumor cells in evading the immune system. It is being developed for non-small cell lung cancer, bladder cancer, gastric cancer, pancreatic, hepatocellular carcinoma, and blood cancer, in addition to head and neck cancers.
The drug even was granted Breakthrough Therapy designation by the FDA for certain patients with urothelial bladder cancer earlier this year.
The company is planning to have pivotal data from trials investigating durvalumab monotherapy, or in combination in patients with lung cancer within the first half of next year, according to the press release.
The FDA’s partial clinical hold follows AstraZeneca’s voluntary cessation of enrolling new patients with head and neck squamous cell carcinoma from entering the trials. They chose to pause enrollment due to observed bleeding events during the safety monitoring of phase 3 KESTREL and EAGLE clinical trials.
AstraZeneca reports that bleeding is a known risk factor in patients with head and neck cancers due to disease factors, the location of the tumor in relation to major blood vessels, and previous treatments of surgery and radiation.
They have submitted their analysis of the adverse effects to the FDA for review, and plan to provide more information if requested. If the partial clinical hold is lifted, new patients will be enrolled immediately, AstraZeneca concluded.