AstraZeneca resumes enrolment for new cancer drug trial

AstraZeneca said on Tuesday that it will resume enrolment for a new cancer drug trial of durvalumab after the US Food and Drug Administration lifted a partial clinical hold on the enrolment of new patients with head and neck cancer.

The pharmaceutical company said the Phase III Kestrel trial has already reopened for new patient enrolment at some clinical study sites and the Eagle trial is due to resume recruitment shortly, without amendments to either protocol.

Astra said it will progressively resume enrolment for all head and neck squamous cell carcinoma trials across the participating sites in the US and globally, subject to national health authority and ethics committee approval where required.

The partial clinical hold on new patient enrolment was communicated on 27 October, after preliminary findings from ongoing clinical trials related specifically to head and neck cancer.

The FDA lifted the partial hold after a review of the comprehensive analysis provided by AstraZeneca of bleeding events that were observed as part of the routine safety monitoring of the Phase III Kestrel and Eagle trials.