IDEAYA Biosciences (IDYA) 7th Annual Evercore ISI HealthCONx Healthcare Conference summary

Clinical development updates

• Darovasertib's front-line registration trial in metastatic uveal melanoma has surpassed 150 patients enrolled, with a target of about 230; enrollment is ahead of schedule and a data readout for potential accelerated approval is possible by the end of next year.

• Comparator arm uses physician's choice, with historical PFS around three months; confidence remains high that comparator outcomes will align with past data.

• Efficacy of Darovasertib appears consistent regardless of HLA-A2 status, supporting a compendia-based path for A2-positive patients without a separate registration trial.

• Commercial expectations are for broad adoption in metastatic uveal melanoma, with front-line use in A2-negative and significant uptake in A2-positive populations.

• Launch trajectory and pricing are expected to be comparable to Immunocore, with ultimate success dependent on PFS and OS data quality.

Neoadjuvant and adjuvant strategies

• Neoadjuvant uveal melanoma presents high unmet need; eye preservation rates over 50% far exceed FDA's 10% threshold for full approval.

• Vision preservation and reduction of macular edema are key benefits observed, with ongoing expansion of patient follow-up data.

• FDA has agreed that full approval can be based on either eye preservation or vision-sparing endpoints, with event-free survival needing only to show no detriment.

• Neoadjuvant therapy duration has been extended up to 12 months based on investigator feedback, with six months anticipated as typical.

• Adjuvant trials would require large, long-term studies with RFS superiority; focus remains on neoadjuvant for faster commercialization and potential survival benefit.

Pipeline and combination therapy highlights

• MAT2A program targets MTAP-deleted tumors, representing up to 15% of all solid tumors; lung, urothelial, gastric, and esophageal cancers are top priorities.

• IDE397 monotherapy and PRMT5 combinations (with Amgen and an internal candidate) are advancing, with internal PRMT5 expected in clinic by mid-next year.

• Gilead's Trodelvy is being combined with IDE397 in urothelial cancer, showing early activity.

• Werner helicase inhibitor, partnered with GSK, is in clinical stage with plans to present differentiation data; focus is on high microsatellite instability cancers.

• PARG inhibitor, a first-in-class agent, is entering expansion as monotherapy and in combination with Merck's Keytruda, with potential to enhance Topo ADC efficacy.