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Ideaya Biosciences Announced Clinical Data For The IDE397 Phase 2 Monotherapy Expansion Dose In Methylthioadenosine Phosphorylase-deletion Urothelial And Non-small Cell Lung Cancer Patients

Author: Benzinga Newsdesk | July 08, 2024 06:02am

~39% Overall Response Rate (ORR): 1 CR and 6 PRs (2 awaiting confirmation) by RECIST 1.1 out of 18 evaluable MTAP-deletion urothelial and NSCLC patients
~94% Disease Control Rate (DCR): 1 CR and 6 PRs and 10 SD by RECIST 1.1
~78% of Patients with Tumor Shrinkage: 14 patients observed tumor shrinkage
~81% ctDNA Molecular Response Rate (MRR): 13 of 16 patients with > 50% ctDNA reduction
AE Profile: ~5.6% drug-related grade >3 AEs and no drug-related SAEs or discontinuations at 30 mg once-a-day expansion dose
IDE397 expansion dose of 30 mg once-a-day achieved target drug coverage and plasma SAM pharmacodynamic reduction associated with preclinical tumor regressions
~48k U.S. annual incidence of MTAP-deletion urothelial cancer and NSCLC, with high unmet need and no FDA-approved therapies for MTAP-deletion solid tumors

Posted In: IDYA