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ASCO 2015: Entolimod May Be a Promising Treatment Option for Many Solid Tumors

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Key Points

  • Among 26 participants in this dose-escalation study, 8 patients had stable disease for more than 6 weeks following treatment with entolimod.
  • Three patients maintained disease stability for longer than 12 weeks.
  • Mild-to-severe (but manageable) side effects such as hypotension and hyperglycemia were observed in some patients.

A collaborative team of researchers led by Alex A. Adjei, MD, PhD, FACP, of Roswell Park Cancer Institute, shared results from the first clinical study of the anticancer effects of the novel agent entolimod on May 30 at the 2015 ASCO Annual Meeting in Chicago (Abstract 3063). Their findings confirm preclinical evidence that the agent, derived from Salmonella flagellin, is worthy of further investigation as treatment for some of the most common and most resilient solid-tumor cancers.

Toll-like receptors are a family of proteins that help generate immune responses against cancer and other pathogens. Entolimod, the lead drug candidate of Cleveland BioLabs Inc, activates Toll-like receptor 5 (TLR5) and has been shown to have immunotherapeutic effects in preclinical cancer models.

Dr. Adjei and colleagues evaluated the agent’s safety, tolerability, pharmacokinetics, immunoactivity, and preliminary antitumor activity in patients with a number of different advanced cancers, including colorectal, non–small cell lung, anal, and urothelial bladder tumors.

Study Results

Among 26 participants in this dose-escalation study, 8 patients had stable disease for more than 6 weeks following treatment with entolimod, and 3 patients maintained disease stability for longer than 12 weeks. The tolerability profile in patients with advanced cancer was similar to that observed in two previous studies in 150 healthy volunteers who received entolimod in a similar dose range. Mild-to-severe (but manageable) side effects such as hypotension and hyperglycemia—all anticipated effects of TLR5 activation—were observed in several patients. The results corroborated preclinical findings and suggest that entolimod should be further studied as an immunotherapeutic anticancer agent.

“Our findings are encouraging, as they suggest that entolimod can be safely combined with other chemotherapeutic, targeted, or immunotherapeutic agents as treatment for advanced and very hard-to-treat cancers,” noted Dr. Adjei, who is Senior Vice President of Clinical Research and the Katherine Anne Gioia Chair in Cancer Medicine at Roswell Park. “We’ve identified a recommended dosing schedule for future studies.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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