Progress on Preventing Immune-Related Adverse Events

Dr. Weber

Dr. Weber said other key points under investigation include investigating whether patients with prior autoimmune disease and prior irAEs with checkpoint inhibition are at risk of developing subsequent irAEs with further therapy, “but it is usually manageable.”

He also said evidence is mounting that autoantibodies are associated at baseline with subsequent development of some irAEs and that cytokine levels of interleukin (IL) 6 and tumor necrosis factor alpha (TNFα) are likely to be associated with irAEs. “Also, T cell mediated mechanisms and microbial species are associated with irAEs.”

He also made a prediction. “An amalgamated biomarker will be generated that will help us predict who will develop irAEs in the near future.”

Elad Sharon, MD, MPH, joined CTEP in December 2011 as a senior investigator in the Investigational Drug Branch, where he works with academia and industry to develop promising cancer therapies. He said a key part of the program’s research is “learning from our mistakes.” CTEP manages about 750 clinical trials around the country, “and an increasing number of those are related to immunotherapy.” Dr. Sharon said that while it’s encouraging to see many patients deriving significant benefit, a big focus of CTEP is “monitoring safety.”

CTEP publishes Common Terminology Criteria for Adverse Events (CTCAE). It has a number of initiatives, including the Immune-Related Adverse Event Biorepository, which is scheduled to open in 2020. Other key areas of investigation include vaccines to induce immune response against presumed cancer antigens.

Dr. Sharon

One ambitious program underway—which Dr. Sharon co-manages—is NCI-10204: The AIM-NIVO a Phase 1b Study of Nivolumab in Patients with Autoimmune Disorders and Advanced Malignancies (AIM-NIVO).

AIM-NIVO “put together a collection of oncologists and subspecialty autoimmune specialists from across the country to try and better understand what these drugs do in patients who have underlying autoimmunity conditions,” said Dr. Sullivan.

Mike Fillon is a healthcare writer living in the Atlanta area.