IDEAYA Biosciences (IDYA) 7th Annual Oncology Innovation Summit: Insights for ASCO & EHA summary

Clinical trial updates and results

• Darovasertib phase II/III in HLA-A*02-negative metastatic uveal melanoma showed a hazard ratio of 0.42, p-value <0.0001, and median PFS of 6.9 vs. 3.1 months for control, with response rate trending toward 40%.

• Full results, including CT scan waterfall plots and safety data, will be presented at a late breaker oral session on June 1st.

• OS data previously reported at over 21 months vs. 12.5 months for ipi/nivo; similar efficacy seen in HLA-A*02-positive and negative cohorts.

• Enrollment for HLA-A*02-positive cohort (~100 patients) is complete, with data to be submitted for NDA and major conference presentation.

• Real-Time Oncology Review (RTOR) and Fast Track designation received, enabling rolling NDA submission and potential expedited review.

Pipeline and development strategy

• Neoadjuvant OptimUM-09 phase II data in uveal melanoma to be updated in the second half of the year, with more patients and longer follow-up.

• Adjuvant study aims to enroll ~450 patients, randomized against observation, with a 12-month treatment duration and primary endpoint of relapse-free survival; readout expected in 3–3.5 years.

• Patients may receive darovasertib across neoadjuvant, adjuvant, and metastatic settings, with potential for rechallenge after washout.

• Combined market opportunity for darovasertib in uveal melanoma could reach multi-billion dollar levels, especially if HLA-agnostic labeling is achieved.

ADC and bispecific programs

• IDE849 (DLL3 ADC) targets small cell lung cancer and neuroendocrine carcinoma, differentiated by a tetrapeptide cleavable linker allowing higher dosing and potentially better safety.

• Over 100-patient data set to be presented, including response rate, PFS, and landmark 12-month OS; U.S./Europe/Asia expansion ongoing.

• Proprietary combination with PARG inhibitor (IDE161) may enhance durability and competitive advantage.

• IDE034 (B7-H3/PTK7 bispecific) designed for avidity advantage and tumor-specific delivery, with early data expected in multiple solid tumors, including colorectal cancer.