FDA places partial hold on AstraZeneca’s two cancer drug trials

The trials in question are testing whether a drug called durvalumab, used alone or in combination with tremelimumab or other potential medicines, prolongs survival in patients with head and neck cancer.

AstraZeneca said all trials are continuing with existing patients and the partial clinical hold on new patient enrolment relates only to head and neck cancer.

Trials of durvalumab and tremelimumab in different cancer types are also progressing as planned. The data in lung cancer is expected in the first half of next year.

AstraZeneca said it is working with the agency, providing the required data to restart new patient enrolment as early as possible.

The partial clinical hold was placed to make an analysis on adverse events related to bleeding. The effort is part of routine safety monitoring of the Phase 3 KESTREL and EAGLE studies.

Earlier this year, AstraZeneca secured breakthrough therapy designation (BTD) from the FDA to treat patients with programmed death ligand-1 (PD-L1) positive urothelial bladder cancer.

Durvalumab is an investigational human monoclonal antibody directed against PD-L1. Signals from PD-L1 help tumours prevent detection by the immune system.

The antibody blocks those signals to counter the immune-evading tactics of the tumour.

Image: FDA suspends recruitment in AstraZeneca's clinical trials of durvalumab in head and neck cancer. Photo: courtesy of AstraZeneca.