0001193125-26-151893
SEC filingIDEAYA Biosciences and Servier announced positive Phase 2/3 OptimUM-02 topline results showing darovasertib plus crizotinib met primary PFS endpoint and improved ORR in 1L HLA-A*02:01-negative mUM, targeting FDA NDA in H2 2026.
The OptimUM-02 trial results represent a potential breakthrough for first-line treatment of HLA-A*02:01-negative metastatic uveal melanoma, a population with limited options. The darovasertib plus crizotinib combination demonstrated superior efficacy over standard investigator's choice, which was predominantly ipilimumab-nivolumab (76%) or pembrolizumab (24%). The 58% risk reduction in progression (HR 0.42) and more than doubled median PFS (6.9 vs 3.1 months) strongly support the primary endpoint for registrational purposes. ORR of 37.1% with 5 complete responses markedly outperforms the 5.8% in the control arm, indicating robust anti-tumor activity. Median DOR of 6.8 months further underscores durability. While OS data remains immature, the early positive trend is encouraging for investors monitoring long-term outcomes. Safety aligns with known profiles of the agents, with no new signals; low serious AE rate bolsters commercial viability. These data position IDEAYA for NDA filing in H2 2026, potentially accelerating approval and partnership value with Servier, enhancing pipeline prospects in precision oncology.