IDEAYA Biosciences(US:IDYA) Prnewswire·2024-06-25 10:00Core Viewpoint - IDEAYA Biosciences has initiated a Phase 1 clinical trial to evaluate the combination of IDE397, a MAT2A inhibitor, and Trodelvy, targeting patients with MTAP-deletion bladder cancer [12][5]. Group 1: Clinical Trial Details - The Phase 1 trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of the IDE397 and Trodelvy combination [5][12]. - MTAP-deletion is present in approximately 26% of bladder cancer patients, indicating a significant target population for this treatment [5]. - The trial is part of a broader clinical program that includes a Phase 2 expansion arm for IDE397 monotherapy in MTAP-deletion solid tumors [1][5]. Group 2: Product Information - Trodelvy is currently approved in nearly 50 countries for second-line metastatic triple-negative breast cancer and in over 30 countries for pre-treated HR+/HER2- metastatic breast cancer [5]. - In the U.S., Trodelvy has received accelerated approval for treating locally advanced or metastatic urothelial cancer in patients who have previously undergone platinum-containing chemotherapy and anti-PD-(L)1 therapy [5]. Group 3: Future Developments - IDEAYA plans to provide a clinical data update for the IDE397 Phase 2 monotherapy expansion in MTAP-deletion bladder and lung cancer in the second half of 2024 [9]. - The company is also advancing multiple preclinical stage MTAP-deletion programs to enable wholly-owned combinations with IDE397, targeting a Development Candidate nomination in the second half of 2024 [9].