ORIC to Advance Enozertinib to Phase 3 Trial Following Strong Phase 1b NSCLC Data

ORIC Pharmaceuticals announced positive updated data from its Phase 1b trial of enozertinib in non-small cell lung cancer (NSCLC) with EGFR atypical mutations. The drug demonstrated meaningful systemic and intracranial antitumor activity with a favorable safety profile. Based on these results and FDA feedback, the company plans to initiate a global Phase 3 registrational trial in the first half of 2027.

Key Details

• Phase 1b Efficacy: As of the Sept. 4, 2026 cutoff, enozertinib showed a confirmed systemic objective response rate (ORR) of 80% by BICR and a 67% intracranial ORR by BICR RANO-BM in a patient group where 65% had brain metastases at baseline.
• Safety Profile: The treatment was well tolerated, with no Grade 4 or 5 treatment-related adverse events (TRAEs) and no discontinuations due to TRAEs.
• Next Steps: The company plans to initiate "Redwood-1," a global Phase 3 trial, in the first half of 2027 to evaluate enozertinib in approximately 360 patients with EGFR atypical NSCLC. The trial's dual primary endpoints are ORR for potential accelerated approval and progression-free survival (PFS) for full approval.