IDEAYA Biosciences (IDYA) Status update summary

Clinical program updates

• Lead program 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 end of March, with PFS as the primary endpoint.

• Prior data show a 7-month PFS in the treatment arm versus 2-3 months in the control, with OS around 21 months and a tripled response rate.

• The phase III trial enrolled 313 patients (2:1 randomization), with 130 PFS events triggering the interim analysis.

• Data cleaning is underway, and the NDA filing is targeted for six months post-readout, with FDA review expected to take another six months.

Trial design and regulatory strategy

• The phase III trial compares darovasertib plus crizotinib to standard of care (checkpoint inhibitors or chemo) in HLA-A2 negative metastatic uveal melanoma.

• No crossover is allowed until OS reads out; OS interim analysis is expected in the first half of next year.

• The primary endpoint is PFS by blinded independent central review; OS and safety will be key secondary endpoints.

• Phase IIa included 124 patients for dose optimization; phase IIb/III includes 313 patients for efficacy analysis.

• HLA-A2 positive data from a separate phase II trial (about 100 patients) will be submitted in parallel to support broader labeling.

Safety and management

• Safety profile is expected to be consistent with prior studies, with low discontinuation rates due to improved AE management.

• Dose reductions are infrequent and typically involve crizotinib, not darovasertib; most toxicities occur in the first two months.

• Investigators are experienced in managing side effects, helping patients remain on therapy.