ORIC's Enozertinib Hits 84% ORR, Sets Phase 3 Redwood-1 for 1H 2027
ORIC sits 84% above its 52-week low of $7.23.
Summary
ORIC reported Phase 1b enozertinib data at ESMO showing 84% confirmed systemic ORR and 67% intracranial ORR by BICR in first-line EGFR atypical NSCLC, and said it will start the global Phase 3 Redwood-1 trial in 1H 2027 after FDA End-of-Phase 1 alignment.
Key Events · Product Development and Regulatory · ORIC
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Enozertinib Posts 84% Systemic ORR
Among 25 response-evaluable first-line EGFR atypical NSCLC patients, confirmed systemic ORR was 84% (21 of 25) by investigator and 80% (20 of 25) by BICR, with a 100% disease control rate.
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Intracranial Activity Beats Benchmark
Confirmed intracranial ORR was 70% by investigator (n=10) and 67% (10 of 15) by BICR RANO-BM, including 40% (6 of 15) complete responses — despite 65% of patients having baseline brain metastases and 46% having previously untreated CNS disease.
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Phase 3 Redwood-1 Set for 1H 2027
After completing FDA End-of-Phase 1 interactions, ORIC plans a ~360-patient global Phase 3 randomizing enozertinib 80 mg QD against osimertinib or afatinib, with dual primary endpoints of ORR by BICR (accelerated approval) and PFS by BICR (full approval).
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Clean Safety Supports Combination Use
Six patients (23%) had Grade 3 TRAEs, all resolved with dose modifications; there were no Grade 4 or 5 TRAEs and zero treatment discontinuations due to TRAEs.
Analysis · ORIC · Life Sciences
Enozertinib posted an 84% confirmed systemic ORR by investigator (80% by BICR) in first-line EGFR atypical NSCLC, and it did so in a population with 65% baseline brain metastases — more than double the CNS disease rate in competitor datasets. That matters because CNS-penetrant best-in-class TKIs have historically taken majority share of their class, and ORIC now has FDA End-of-Phase 1 alignment to move into a ~360-patient global Phase 3 (Redwood-1) in 1H 2027 with dual primary endpoints of ORR (accelerated approval) and PFS (full approval). The intracranial data — 67% ORR by the stringent BICR RANO-BM criteria with 40% complete responses — is the piece competitors have not shown in this mutation set. Execution and funding are the risks: a Phase 3 of this size is expensive, and the company has been funding itself through its ATM.
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At the time of this filing, ORIC was trading at $13.32 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.4B. The 52-week trading range was $7.23 to $14.68. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.