AstraZeneca allowed to recruit for drug trial again

pharmafile | November 22, 2016 | News story | Manufacturing and Production, Research and Development |  AstraZeneca, FDA, clinical trial 

AstraZeneca’s clinical trial for head and neck cancer had previously been put on partial hold by the FDA due to issues with bleeding. The trial was put on hold on 27 October but has now begun recruiting again.

The two trials involved are at phase III, they are named Kestrel and Eagle. Bleeding is a common complication when treating head and neck cancer, due to the proximity of tumours to major blood vessels. On submission of analysis to the FDA, recruitment for the Kestrel trial has once again been opened and the Eagle is expected to resume recruitment shortly.

In a statement, AstraZeneca commented that: “The FDA lifted the partial clinical hold following 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.”

The trials are looking into the durvalumab when used alone or in combination with another of AstraZeneca’s experimental cancer therapy drugs, tremelimumab. The endpoint of the trial is how far these drugs extend lifespan in patients.

AstraZeneca has a considerable amount of catch up to be done with Bristol Myers, Merck and Roche already having progressed single drug therapies. By trialling a combination therapy, AstraZeneca hopes to be able to gain significant ground on the leading pack.

Ben Hargreaves