The launch of a Phase II trial of the experimental PI3Kδ-targeting agent AMG319 in head and neck squamous cell carcinoma (HNSCC) has today been announced. The trial – a collaborative endeavor between Cancer Research UK’s Centre for Drug Development and Amgen Inc. (CA, USA) – will aim to determine whether AMG319 can prevent the immune system shielding tumors.
“This is a really exciting trial because we’re using this drug in solid tumors 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 tumor. We will study in detail how the immune cells behave before and after AMG319 and whether they have become more effective,” explained Christian Ottensmeier, trial lead of the University of Southampton (UK).
AMG319 was initially developed as a potential therapy for leukemia as it targets the PI3Kδ protein, which is predominantly found in white blood cells. When activated, PI3Kδ allows white blood cells to multiply rapidly – a known hallmark of cancer.
The Cancer Research UK team believe that AMG319 could be harnessed in HNSCC to deactivate the regulatory T-cells that can diminish or prevent an antitumor immune response. Preclinical lab tests demonstrated that inhibiting PI3Kδ with AMG319 led to the destruction of the cancer cells.
Moving into the clinic, this Phase II trial will take place at Poole Hospital, Southampton General Hospital, and the Clatterbridge Cancer Centre/Aintree University Hospital (all UK), and will include approximately 54 patients with HPV-negative HNSCC. Patients will be randomly assigned to receive either AMG319 or a placebo during a regular break from treatment to avoid disruption to a patient’s care.
Tony Hoos, Head of Medical for Europe at Amgen, commented: “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.”