IDEAYA Biosciences, Inc. announced on April 10, 2025, the initiation of a Phase 1/2 expansion in the clinical trial evaluating IDE397 in combination with Gilead's Trodelvy® (sacituzumab govitecan-hziy). This expansion focuses on methylthioadenosine phosphorylase (MTAP)-deletion urothelial cancer (UC), based on preliminary safety and clinical efficacy data.
IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A) in patients with MTAP-deletion solid tumors. The prevalence of MTAP-deletion is estimated to be approximately 26% in UC, highlighting a significant unmet medical need as there are no approved therapies specifically for this patient population.
The advancement of this potential first-in-class clinical combination into an initial Phase 1/2 expansion demonstrates confidence in its therapeutic potential. A clinical program update on the IDE397 and Trodelvy combination is planned for 2025.
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