AstraZeneca said Thursday that the FDA placed a partial clinical hold on studies of the experimental drug durvalumab in patients with head and neck cancer due to bleeding incidents. One Phase III study affected is evaluating the PD-L1 inhibitor in combination with the company's CTLA-4 inhibitor tremelimumab. Shares in AstraZeneca fell more than 4 percent on the news.
AstraZeneca noted that the FDA action follows its decision to voluntarily halt enrolment of new patients while an analysis is conducted of adverse events associated with bleeding as observed during routine safety monitoring of the Phase III KESTREL and EAGLE trials. The drugmaker noted that it has submitted its analysis of the observed events to the FDA for review, adding that it is working with the agency to provide information needed to resume patient enrolment as soon as possible.
Meanwhile, AstraZeneca explained that the clinical hold only affects studies of durvalumab in the treatment of head and neck cancer. The company added that studies of the therapy for other cancer indications, either alone or in combination with other drugs such as tremelimumab, are proceeding as planned, with pivotal data in lung cancer awaited next year.