ORIC® Pharmaceuticals Presents Potential Best-in-Class Data for Enozertinib in 1L NSCLC Patients with EGFR Atypical Mutations at ESMO Congress 2026 and Plans to Advance Enozertinib into a Global Phase 3 Trial
ORIC Pharmaceuticals presented Phase 1b data for enozertinib in first-line NSCLC patients with EGFR atypical mutations at ESMO 2026, showing an 84% confirmed systemic ORR and 70% intracranial ORR despite 65% of patients having baseline brain metastases. Safety was competitive, with predominantly Grade 1-2 adverse events, no Grade 4/5 TRAEs, and no treatment-related discontinuations; the 6-month landmark PFS was 88%, though median PFS and DOR remain immature. Supported by completed End-of-Phase 1 FDA interactions, ORIC plans to initiate Redwood-1, a global Phase 3 registrational trial enrolling ~360 patients, in 1H 2027, with dual primary endpoints supporting potential accelerated approval.
Key figures
- Drug Name
- enozertinib (ORIC-114)
- Phase Of Trial
- Phase 1b; Phase 3 (Redwood-1) planned 1H 2027
- Grade3 trae rate
- 23%
- Patients evaluated
- 26
- Six month landmark pfs
- 88%
- Intracranial cr rate bicr
- 40%
- Phase3 planned enrollment
- 360
- Confirmed systemic orr bicr
- 80%
- Intracranial orr bicr rano bm
- 67%
- Intracranial orr investigator
- 70%
- Confirmed systemic orr investigator
- 84%
AI analysis
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