Less than a month after being hit with a partial clinical hold on its head and neck cancer study, AstraZeneca has gotten a reprieve after the U.S. regulator has removed its halt.
At the end of October, the FDA placed the partial hold due to bleeding adverse events in two clinical trials, restricting the Big Pharma from adding new patients to clinical trials for its durvalumab, as monotherapy and in combination, in head and neck squamous cell carcinoma (HNSCC). It shares fell around 4% on the news.
But this morning the British-based co said the regulator “has lifted the partial clinical hold on the enrolment of new patients with head and neck squamous cell carcinoma for clinical trials of durvalumab as monotherapy and in combination with tremelimumab or other potential medicines.”
The company said that its late-stage Kestrel trial has already reopened for new patient enrolment at some clinical study sites, and that the Eagle trial “is expected to resume recruitment shortly, without amendments to either protocol.”
“AstraZeneca will progressively resume enrolment for all HNSCC trials across the participating sites in the US and globally, subject to national health authority and ethics committee approval where required,” it said in a brief update.
The Big Pharma added that bleeding, which is what prompted the initial hold, is a “known complication in treatments of head and neck cancers,” primarily it says due to the “nature of the underlying disease, the proximity of tumours to major blood vessels and use of prior cancer therapies, which may involve surgery and radiation.”
Durvalumab, which won breakthrough therapy designation from the FDA to treat urothelial bladder cancer in February, has suffered several trial setbacks, and a few weeks back AZ said it was scrapping plans to get an early FDA nod for the drug as a second-line HNSCC option.
But it still remains a major prospect for AstraZeneca as it seeks to be the fourth to market this new class of I/O med and the second PD-L1 player after Roche and its Tecentriq (atezolizumab).