Kazia Therapeutics announced the presentation of promising clinical data for EVT801, a highly selective small molecule VEGFR3 inhibitor, in high grade serous (HGS) ovarian cancer. The data, presented at the 15th Biennial Ovarian Cancer Research Symposium, highlights the potential of EVT801 in targeting tumor angiogenesis. The Phase 1 first-in-human clinical trial evaluated the safety and tolerability of EVT801, marking a significant step forward in the development of a potential first-in-class treatment option for ovarian cancer.
Phase 1 Trial Results
The Phase 1 study successfully met its primary objectives, identifying the maximum tolerated dose (MTD) of EVT801 as 500mg twice daily (BID). Furthermore, the study determined the recommended Phase 2 dose, starting at 400mg BID. Across six dosing cohorts, ranging from 50mg once daily (QD) to 500mg BID, a total of 26 patients were treated. The trial included patients with eleven different cancer types, with heavily pretreated advanced ovarian cancer being the most prevalent indication, accounting for 11 patients.
Clinical Activity in Ovarian Cancer
Encouraging clinical activity was observed in HGS ovarian cancer patients. Forty-six percent (46%) of these patients achieved stable disease or better for at least three cycles, including two patients who received nine cycles. Notably, one patient experienced a partial response, with a 39% decrease in tumor size after two cycles of EVT801 therapy. Biomarker analysis also revealed strong VEGFR3 expression in multiple indications, including ovarian cancer, suggesting a potential mechanism of action for EVT801.
Safety and Tolerability
EVT801 demonstrated a favorable safety profile, being well-tolerated across all doses tested. The majority of toxicities reported were mild to moderate and transient in nature, indicating that EVT801 could be safely administered in future clinical trials and potentially in clinical practice.
Expert Commentary
"I was honored to participate at the Ovarian Cancer Research Symposium and present our findings to fellow clinicians and ovarian cancer researchers from around the globe," said Dr. John Friend, CEO of Kazia Therapeutics. "Ovarian cancer is often diagnosed at late stages with poor patient prognosis, so the data from the Phase 1 study is extremely encouraging and gives us confidence that we could potentially have a first-in-class VEGFR-3 inhibitor with EVT801."
