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IDYABullishIndustry Newsnews
High materiality7/10

IDYA's ESMO 2026 data reinforce darovasertib-crizotinib potential in uveal melanoma

Oct 19, 2026, 6:44 AM EDT1 sourcesAI-analyzed
Why it may matterVerify against the original reporting

Positive phase 2/2-3 signals with cross-HLA status efficacy, NDA timing under RTOR, and a strategic international licensing deal; could drive earnings revisions and upside in IDEAYA shares.

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What happened, with direct paths to the underlying reporting

IDEAYA reports updated OptimUM data ahead of ESMO 2026, showing darovasertib plus crizotinib delivering meaningful activity across metastatic uveal melanoma regardless of HLA-A*02:01 status. OptimUM-02 suggests added first-line benefit in HLA-A*02:01-negative disease, while OptimUM-09 neoadjuvant results indicate enhanced eye preservation. An NDA submission is targeted in 2H2026 under RTOR, with Servier’s international rights shaping potential revenue milestones.

  • OptimUM-01/OptimUM-02 data at ESMO 2026 show darovasertib + crizotinib activity across HLA-A*02:01 status.
  • 1L OptimUM-01: PFS 7.4 months, OS 27.1 months in 13 treatment-naïve patients; ORR 36.4%.
  • 1L OptimUM-02: 1L HLA-A*02:01-negative PFS ~6.9 months vs ICT ~3.1 months.
  • OptimUM-09 neoadjuvant: ~80% tumor shrinkage; 57% eye preservation; RTOR NDA planned in 2H 2026.
  • Servier secures exclusive rights outside US; NDA submission target and RTOR program highlight near-term catalysts.

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