AZ halts recruitment on head and neck cancer trial

AstraZeneca has suffered a blow after it halted recruitment into two late-stage trials in head and neck cancer involving an immunotherapy combination, after reports of bleeding.

The US Food and Drug Administration placed a partial hold on enrolment into the phase 3 trials of durvalumab and tremelimumab – although the studies will continue with existing patients.

AZ already voluntarily paused the KESTREL and EAGLE trials while it analyses adverse events related to bleeding, as part of routine safety monitoring.

The news is particularly concerning for AstraZeneca, as it needs to establish itself in the immuno-oncology field, and had pinned its hopes on proving  combination of novel therapies would be safe and effective.

Bleeding is a known complication in head and neck cancer treatments, due to the nature of the disease, proximity of tumours to major blood vessels and previous therapies which may have involved surgery and radiation.

AZ has submitted its analysis of observed bleeding events to the FDA for review, adding it aims to resume new patient enrolment as soon as possible.

Pivotal data from the ARCTIC trial of the drug combination in non-small cell lung cancer, third line, is due next year. The drug is also in late stage development in bladder cancer.

Durvalumab is a PD-L1 checkpoint inhibitor, making it similar to Roche/Genentech’s Tecentriq, which now has approvals in metastatic urethelial  carcinoma in May and then in non-small cell lung cancer this 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 sales 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, including the new doubts about its oncology franchise, could put this goal out of reach.

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