IDYA IDEAYA

IDEAYA reports updated IDE849 Phase 1 data at ESMO 2026 showing 17.4-mo median OS in 2L SCLC

Hengrui presented updated Phase 1 monotherapy results for IDE849 (DLL3-TOP1 ADC) in relapsed SCLC and NECs at ESMO 2026, adding longer follow-up, larger n=122, first preliminary OS data (17.4 mo median in 2L SCLC), mature PFS, high ORR including in brain metastases, and manageable safety. IDEAYA plans global Phase 3 trials in post-Imdelltra ES-SCLC and NEC following FDA Type C meetings; first global study update expected end-2026/early-2027.

IDEAYA reports darovasertib + crizotinib and neoadjuvant data at ESMO 2026 in uveal melanoma

IDEAYA presented updated Phase 2 data from OptimUM-01, subgroup analyses from registrational OptimUM-02, and longer follow-up from OptimUM-09 at the ESMO Congress 2026. The results support potential use of darovasertib across metastatic (irrespective of HLA-A*02:01 status or line of therapy) and primary (neoadjuvant eye-preservation) uveal melanoma settings.

darovasertib · NCT07804186 registry update

countries: {'total_sites': 1, 'us_sites': 0} → {'total_sites': 13, 'us_sites': 11}

IDEAYA: OptimUM-02 Phase 2/3 darovasertib + crizotinib meets PFS endpoint

The OptimUM-02 trial met its primary endpoint, showing a statistically significant 58% reduction in risk of progression (HR 0.42) and median PFS of 6.9 months versus 3.1 months with investigator choice therapy. ORR was 37.1% versus 5.8%, with 5 complete responses in the darovasertib arm. IDEAYA plans to submit an NDA in H2 2026 based on these data.