Trial for potential new drug that could help immune system fight cancer
Cancer Research UK's Centre for Drug Development (CDD), in partnership with Amgen Inc., has launched a new clinical trial to test a drug that could stop a patient's immune system from protecting tumours.
Cancer Research UK scientists are studying Amgen's experimental cancer drug , called AMG319, to find out if it removes the defence shield that hides cancer cells from the immune system. It targets a protein called PI3K delta leading to destruction of the cancer cells when tested in the laboratory.
The Phase II trial, taking place at Poole Hospital, Southampton General Hospital, and the Clatterbridge Cancer Centre/Aintree University Hospital, looks at the effects of giving this drug to patients with a type of head and neck cancer known as squamous cell carcinoma (HNSCC), to determine whether it affects their immune response.
There will be around 54 patients with HPV-negative* HNSCC of the lower and upper parts of the throat (hypopharynx and oropharynx) or mouth in the study. Patients will be randomly assigned to receive either AMG319 or a placebo, during the regular break from treatment to avoid disruption to a patient's care.
It is the 10th treatment to enter Cancer Research UK's Clinical Development Partnerships (CDP) scheme.
CDP is a joint initiative between Cancer Research UK's CDD and Cancer Research Technology, aiming to increase the number of cancer clinical trials and to progress promising anti-cancer agents by working in partnership with pharmaceutical companies.
Professor Christian Ottensmeier, trial lead from the University of Southampton and the Southampton Experimental Cancer Medicine Centre, said: "This is a really exciting trial because we're using this drug in solid tumours for the first time. It also tries a whole new concept of cancer therapy in solid cancers for the first time. We hope that after taking the drug, patients will have more cancer fighting immune cells in their tumour. We will study in detail how the immune cells behave before and after AMG319 and whether they have become more effective."
Dr Emma King, clinical lead at the Poole Hospital, said: "I am really pleased that this trial gives our head and neck cancer patients and opportunity to get this new drug."
Tony Hoos, Vice president of Medical, Europe at Amgen, said: "The intersection of immunology and oncology represents one of the most promising approaches which may have a significant impact for patients with cancer today.
"We value the work that Cancer Research UK has done to make it possible to develop this promising drug to the next stage. This new trial will give us a better understanding of how AMG319 works, helping us learn more about its potential in patients who might benefit."
Dr Nigel Blackburn, Cancer Research UK's director of drug development, said: "We're delighted that the collaboration between Amgen and our Centre for Drug Development is moving into Phase II trials. It means we're getting closer to providing a new treatment for cancer patients.