The results were presented by Virginia F. Borges, M.D., Associate Professor in the Division of Medical Oncology, University of Colorado School of Medicine. ONT-380 (also known as ARRY-380) is an orally active, reversible and selective small-molecule HER2 inhibitor being developed by Oncothyreon in collaboration with Array BioPharma Inc. (Nasdaq: ARRY), Boulder, Colorado.
The first-in-human Phase 1 trial, with both dose-escalation and expansion components, enrolled a total of 50 patients, 43 of whom had HER2+ metastatic breast cancer. In this study, ONT-380 demonstrated an acceptable safety profile; treatment-related adverse events were primarily Grade 1. Because ONT-380 is selective for HER2 and does not inhibit EGFR, there was a low incidence and severity of treatment-related diarrhea, rash and fatigue, side effects which have been associated with EGFR inhibition.
A single patient experienced Grade 2 treatment-related diarrhea and no patient developed treatment-related Grade 3 diarrhea; one patient had a Grade 3 rash. Additionally, there were no treatment-related cardiac events or Grade 4 treatment-related adverse events reported. The maximum tolerated dose of ONT-380 established in this Phase 1 trial was 600 mg twice daily. The dose-limiting toxicity was reversible elevation in liver enzymes.
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