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Last Updated: 10/13/2016

DCTD’s Cancer Therapy Evaluation Program Convenes Early Drug Development Meeting

On September 26-27, 2016, the Cancer Therapy Evaluation Program (CTEP) sponsored its annual Early Drug Development (EDD) meeting. The EDD meeting is an educational event focused on enhancing communications between the NCI and the network of CTEP-supported Experimental Therapeutics Clinical Trials Network (ETCTN)-funded early clinical trial investigators. Academic, government, and pharmaceutical company clinical investigators and related health care personnel involved in oncology early drug development attended this meeting, which consisted of a diverse spectrum of educational sessions, clinical trial update presentations, keynote lectures, and closed meetings with ETCTN investigators.

Highlights from the meeting included four speakers who discussed status updates of CTEP-sponsored early phase immunotherapy trials in a variety of tumors, and a keynote presentation by Dr. Evan Lipson on recognizing and managing checkpoint inhibitor toxicities. Ten speakers discussed clinical trial updates of CTEP-sponsored Phase 1 and Phase 2 studies across the U.S., including NCI’s Center for Cancer Research and Developmental Therapeutics Clinic. The Michaele C. Christian Oncology Drug Development Award and Lectureship to honor a mid-career oncology investigator was given to Dr. Glenn Liu of the University of Wisconsin Carbone Cancer Center.

In addition, eight speakers and 14 interventional radiologists from U.S. cancer centers and NCI participated in a half-day educational session on improving research biopsy quality, which included presentations and a panel discussion. The goal was to exchange information about critical characteristics of tumor biopsies for biomarker evaluation, current research tumor biopsy best practices, and the role of radiologists and clinical trial tumor biopsies for correlative studies in the era of personalized medicine. The impetus for convening this diverse group was the changing requirements for biopsy tissues in pharmacodynamics research and genomics, as opposed to cancer diagnosis, where biopsy quality — specifically, whether the sample contains enough cancer cells for analysis — is of paramount importance. Due to the recent emergence of precision medicine and pharmacodynamics-driven drug development, cancer biopsies are now often also molecularly characterized to aid oncologists and clinical researchers in obtaining information about targeted treatment effects in clinical trials where both paired pre- and post-drug treatment samples are needed. Among several recommendations to promote consistently high-quality biopsies that are required for these additional procedures, the attendees urged improved communication among interdisciplinary teams of oncologists, interventional radiologists, pathologists, and laboratory staff who obtain and analyze biopsies for precision medicine cancer clinical trials. A comprehensive report of the recommendations from this session is being prepared for widespread dissemination to the cancer community.

Contact John Wright, MD, PhD with questions about the EDD meeting.