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IDEAYA Biosciences (IDYA) investor relations material
IDEAYA Biosciences Evercore ISI 8th Annual HealthCONx Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Pipeline and clinical development updates
Lead program Darovasertib is nearing a key randomized median PFS readout for metastatic uveal melanoma, with potential accelerated approval filing in the U.S. expected by year-end or early next year.
Full enrollment for the median OS component in the registrational study is nearly complete, targeting over 450 patients.
Additional registrational trials for Darovasertib include a phase 3 neoadjuvant trial (sites activated, patients screening) and a phase 3 adjuvant trial launching in the first half of next year.
Breakthrough therapy designation was received for the neoadjuvant indication based on strong eye preservation data.
Multiple clinical assets in the MTAP pathway are advancing, including phase 2 MAT2A inhibitor, phase 1 PRMT5 inhibitor, and a new program targeting CDKN2A co-alteration.
Clinical data and patient impact
In uveal melanoma, there are no approved systemic therapies for neoadjuvant or adjuvant settings, and most metastatic patients lack approved options.
Neoadjuvant trial aims to exceed a 10% eye preservation rate; recent data show the majority of patients preserving their eyes, supporting breakthrough designation.
Plaque therapy cohort targets a 20% or greater improvement in vision (15-letter BCVA test) versus control, with secondary endpoints for event-free survival.
Neoadjuvant treatment showed a mean 14-letter vision gain pre-procedure, potentially improving outcomes post-radiotherapy.
ADC and targeted therapy programs
DLL3 topo ADC in small cell lung cancer showed a 70% confirmed response rate at 2.4 mg/kg and a PFS of 6.7 months, with grade 3+ AEs under 20%.
Dose intensity is critical for efficacy; discontinuations and dose interruptions were infrequent.
Plans to develop DLL3 ADC in both small cell lung cancer and neuroendocrine tumors, with additional data updates expected next year.
Resistance to DLL3 therapies is not expected to arise from antigen downregulation due to its link to ASCL1; distinct binding epitopes may allow for combination strategies.
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