AZ resumes key head and neck cancer trials
AstraZeneca is resuming late-stage development of two head and neck cancer immunotherapies, after the US FDA lifted a partial hold on clinical trials involving the drugs.
Late last month the FDA called for a partial clinical hold on two phase 3 trials assessing durvalumab as a monotherapy, or in combination with tremelimumab or other potential medicines, in head and neck squamous cell carcinoma (HNSCC).
The regulator called for the halt after reports of bleeding – but is satisfied about the drug’s safety following an analysis of bleeding events provided by AstraZeneca (AZ).
In a statement AZ said the KESTREL trial has already re-opened for new patient enrolment at some clinical study sites and the EAGLE trial is expected to resume shortly, without changes to either protocol.
AZ will progressively resume enrolment for all HNSCC trials across participating sites in the US and globally, subject to national health authority and ethics approval where required.
Durvalumab is a PD-L1 checkpoint inhibitor, making it similar to Roche/Genentech’s Tecentriq.
Tecentriq had US approvals in metastatic urothelial carcinoma in May and then in non-small cell lung cancer last month.
Meanwhile tremelimumab inhibits the activity of cytotoxic T-lymphocyte-associated antigen 4 (CTLA4), boosting the immune response against cancer cells.
The two cancer drugs are part of AZ’s drive to revive revenues after sales of its big cholesterol drug, Crestor (rosuvastatin) plummeted because of generic competition.
Chief executive Pascal Soriot has set AZ a total company revenue target of $45 billion by 2023, but a number of setbacks could put this goal out of reach.
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