IDEAYA Announces Positive Interim Phase 2 Monotherapy Expansion Data for IDE397 a Potential First-in-Class MAT2A Inhibitor in MTAP-Deletion Urothelial and Lung Cancer

Core Insights - IDEAYA Biosciences announced positive clinical data for IDE397, a potential first-in-class MAT2A inhibitor, in a Phase 2 trial for MTAP-deletion urothelial and non-small cell lung cancer (NSCLC) patients [1][3][4] Clinical Efficacy - The overall response rate (ORR) was approximately 39%, with 1 complete response (CR) and 6 partial responses (PRs) reported out of 18 evaluable patients [1][6] - The disease control rate (DCR) reached about 94%, including 1 CR, 6 PRs, and 10 stable disease (SD) cases [1][6] - Approximately 78% of patients experienced tumor shrinkage, with 14 out of 18 evaluable patients showing this outcome [1][6] - The ctDNA molecular response rate was 81%, with 13 of 16 patients achieving over 50% reduction in ctDNA levels [1][6] Safety Profile - The adverse event (AE) profile was favorable, with around 5.6% of patients experiencing grade 3 or higher drug-related AEs, and no serious adverse events (SAEs) or discontinuations reported at the 30 mg once-a-day dose [1][2][6] Market Opportunity - There are currently no FDA-approved therapies for MTAP-deletion solid tumors, indicating a significant unmet medical need [4] - The estimated annual incidence of MTAP-deletion urothelial cancer and NSCLC in the U.S. is approximately 48,000 patients [4] - MTAP-deletion prevalence is reported at over 15% in NSCLC and over 25% in urothelial cancer [4] Future Development - IDEAYA is advancing IDE397 as a monotherapy and in combination with other investigational therapies, including Amgen's AMG 193 and Gilead's Trodelvy [3][5] - The company has activated over 35 clinical trial sites globally to facilitate rapid enrollment for ongoing trials [6]