News from GlobeImmune Inc following their recent financial results... In particular their phase 1 trial of GI-6301
GI-6301 for Cancers Expressing Brachyury Protein
- The National Cancer Institute (NCI) is currently conducting a safety, immunology and early efficacy Phase 1 trial of GI-6301 in patients with late-stage cancers known to express the brachyury protein including chordoma.
- In four previously published Phase 2 chordoma trials since 2005, 2 of 92 chordoma subjects (2%) had a partial response by the Response Evaluation Criteria In Solid Tumors (RECIST), defined as at least a 30% reduction in longest dimension of the tumor. In the literature surveyed, the percent of patients with reported stable disease ranged from 22% to 72%, and the objective response rate (ORR) defined as complete response (CR), partial response (PR) and stable disease (SD) averaged 66%.
- Updated data for the eleven chordoma patients the GI-6301-01 Phase 1 trial were presented in October at the 2014 Connective Tissue Oncology Society (CTOS) Annual Meeting in Berlin, Germany included:
- One partial response (9%) by RECIST that has continued past one year.
- Eight patients (73%) had stable disease by RECIST. 75% of these (6/8) had progressive disease at study entry which stabilized during administration of GI-6301.
- An ORR of 82% (nine of 11 chordoma patients with PR or SD).
- GI-6301 was generally well tolerated; the most common adverse events in this trial were mild/moderate injection site reactions.
"We believe that these results compare favorably with historically published data, and, we and our collaborators, including the NCI, the Chordoma Foundation and Celgene, are now designing a Phase 2 study in chordoma to be run by the NCI," said Dr. Rodell.