ORIC reports strong Phase 1b results for enozertinib and announces Phase 3 trial in 2027
ORIC Pharmaceuticals presented Phase 1b data for its brain‑penetrant EGFR inhibitor enozertinib in first‑line NSCLC patients with atypical EGFR mutations. The study showed an 84% systemic objective response rate and a 70% intracranial response rate. The company said it will launch a global Phase 3 Redwood‑1 trial in the first half of 2027, enrolling about 360 patients, including those with untreated brain metastases. Safety was acceptable, with most adverse events limited to grade 1‑2 and no treatment‑related discontinuations.
Why it matters
The data move enozertinib into late‑stage development, creating a potential new therapy for a high‑unmet‑need NSCLC subgroup; successful Phase 3 results could generate significant revenue for ORIC. The announcement also signals a shift from early‑stage to registrational trials, which may affect the company’s valuation and investor sentiment.
Key facts
- 1Systemic objective response rate was 84% based on investigator assessment. rttnews.com
- 2Intracranial objective response rate was 70% by investigator assessment. rttnews.com
- 3Baseline brain metastases were observed in 65% of patients, with 46% having untreated lesions. rttnews.com
- 4Six‑month landmark progression‑free survival rate was 88%. rttnews.com
- 5Redwood‑1 Phase 3 trial is planned for the first half of 2027 and will enroll approximately 360 patients. rttnews.com
- 6Enozertinib was generally well tolerated; 23% of patients experienced grade 3 treatment‑related adverse events, which resolved with dose adjustments, and no grade 4‑5 events or discontinuations were reported. rttnews.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.