IDEAYA Biosciences (IDYA) Status update summary

Clinical program updates

• Darovasertib is in two phase III studies for metastatic and neoadjuvant uveal melanoma, with a third phase III launch planned soon.

• Top-line results for first-line metastatic uveal melanoma are expected by the end of March, with the primary endpoint being median progression-free survival (PFS).

• DLL3 Topo ADC IDE-849 is targeting a clinical data update by year-end, with potential best-in-class status.

• MTAP deletion programs (PRMT5 and MAT2A) and KAT6/7 dual inhibitor (IDE-574) are advancing, with IDE-574 now in phase I.

Trial design and expectations

• The phase III trial for metastatic uveal melanoma includes 313 patients in the primary analysis, with a 2:1 randomization (treatment:control).

• Interim analysis is triggered by 130 PFS events, with OS analysis planned after 253 events.

• The control arm is expected to show a 2-3 month PFS, while prior data for the treatment arm shows a consistent 7-month PFS and 21-month OS.

• No crossover is permitted until OS reads out, and the primary endpoint is assessed by blinded, independent central review.

Regulatory and filing timelines

• Data cleaning and database lock are ongoing, with top-line PFS results expected by end of March.

• Filing for accelerated approval is anticipated about six months after top-line data, with FDA review expected to take another six months.

• OS interim analysis is expected in the first half of next year, with additional follow-up data to be provided to the FDA.