IDEAYA Biosciences(US:IDYA)2025-11-18 14:02Summary of IDEAYA Biosciences Conference Call Company Overview - Company: IDEAYA Biosciences (NasdaqGS:IDYA) - Industry: Precision medicine oncology - Lead Program: Darovasertib, currently in a registrational trial for frontline metastatic uveal melanoma, with an expected median progression-free survival (PFS) readout by year-end 2025 to Q1 2026 [2][4] Key Clinical Programs - Pipeline: IDEAYA has a deep pipeline with eight clinical stage programs, targeting nine by year-end 2025 [2] - MTAP Deletion Focus: - ID397 (Phase 2 MAT2A inhibitor) - ID892 (Phase 1 MTAP-cooperative PRMT5 inhibitor) [3] - Antibody-Drug Conjugates (ADC): - DLL3 topo ADC with recent presentations at major conferences - Bispecific B7H3 PTK7 ADC (Phase 1) - ID161 (PARG inhibitor) [3] Upcoming Data and Expectations - PFS Events: Approximately 130 PFS events are needed for top-line results, with expectations for results in early 2026 [4] - Control Arm Expectations: Anticipated PFS in the control arm is 2-3 months, while treatment arm results have shown consistent 7-month PFS [5][6] - Overall Survival (OS) Data: OS data from the Society of Melanoma Research (SMR) indicated potential for median OS to increase to 22 months, pending further patient follow-up [13] Regulatory and Market Considerations - NDA Submission: Plans for a pre-NDA meeting with the FDA are anticipated as PFS results are finalized [12] - Pricing Strategy: Expected pricing in the low $50,000s per month, with considerations for the robustness of the dataset and unmet medical needs in the market [14] - Compendia Strategy: Plans to submit HLA-A*02 positive data for potential inclusion in the label, which would enhance promotional capabilities [18][20] Neoadjuvant and Adjuvant Studies - Neoadjuvant Study: Enrollment is expected to accelerate with increased site activation, aiming for completion in approximately five quarters [21] - Adjuvant Program: Planning to start a phase three adjuvant study in collaboration with Servier, targeting 400-450 patients [26] ADC Programs and Future Directions - DLL3 ADC: Positive data supports a potential path for accelerated approval in small cell lung cancer and neuroendocrine tumors [28] - Combination Studies: Plans to explore combinations with standard care agents to enhance treatment durability [34] Additional Pipeline Developments - MAT2A Program: Updates on Trodalvy combo data in urothelial carcinoma expected in the first half of 2026 [39] - CAT67 Program: IND filing planned by year-end 2025, focusing on dual inhibition of CAT6 and CAT7 [45] Conclusion - Key Catalysts: Investors should focus on upcoming PFS results, NDA submission timelines, and ongoing clinical trials across various programs through 2026 [48]