Oncology Central

Unlocking the promise of clinical immunotherapy – a conversation with James Gulley

Oncology Central recently spoke with James Gulley, Director of Medical Oncology Service at the National Cancer Institute (NCI), about his work developing cancer immunotherapies, his insights into the impact of this modality in prostate cancer and his hopes for the future of the field. Discover more below, including details of an early stage trial of a next generation, bi-functional immunotherapy agent with two distinct mechanisms of action.

Could you briefly summarize your career to date & your role at the Medical Oncology Service for Cancer Research?

  • I have been at the NCI since 1998, running immunotherapy clinical trials for patients with cancer. I have focused on therapeutic vaccines, immune checkpoint inhibitors, immunocytokines and combination approaches. I also run the Medical Oncology Service at the NCIs Center for Cancer Research and am the Chief of the Genitourinary Malignancies Branch.

You are the lead investigator for the Phase I clinical trial for a novel immunotherapy termed M7824. The aim of this trial is to investigate the safety and tolerability of M7824. Can you provide us with a brief overview of your findings?

  • This first-in-human study has demonstrated that this agent – M7824 can be safely administered at doses of up to 20 mg / kg every 2 weeks in patients with advanced cancer.

It is associated with two distinct mechanisms of action – binding to PD-L1 (thus blocking negative signals to T cells including one targeting the tumor) and neutralizing TGF-β. It does the latter by binding and sequestering activated TGF-β so it is not available to send negative signals to immune cells and tumor cells.

Finally, the agent has been associated with decreases in tumor size in some patients with several patients having prolonged stable disease, a patient having prolonged partial response and another having a sustained complete response.

What do these results mean for patients?

  • This means that for the first time, patients may have access to an agent that targets two important mechanisms of immune suppression present within the tumor with a single agent.
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    The opinions expressed in this interview are those of the interviewee and do not necessarily reflect the views of Oncology Central or Future Science Group.




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