Enozertinib Hits 84% ORR in 1L EGFR Atypical NSCLC; Phase 3 Set for 1H 2027
ORIC sits 92% above its 52-week low of $7.23.
Summary
ORIC reported Phase 1b enozertinib data at ESMO showing an 84% confirmed systemic ORR by investigator (80% by BICR) in 25 response-evaluable first-line EGFR atypical NSCLC patients, with 70% confirmed intracranial ORR and an 88% six-month landmark PFS. The company argues the results are best-in-class because 65% of patients had baseline brain metastases — more than double competitor datasets — and 46% had previously untreated CNS disease. Safety looked clean: no Grade 4/5 TRAEs and no treatment-related discontinuations. ORIC has completed End-of-Phase 1 talks with FDA and plans to start the global Phase 3 Redwood-1 trial in 1H 2027, roughly 360 patients randomized against osimertinib or afatinib, with dual primary endpoints of BICR ORR (accelerated approval) and BICR PFS. This is the second Phase 3 program for the company, following rinzimetostat in prostate cancer initiated earlier this year, and it materially strengthens the pipeline story behind the current valuation. A conference call with Dr. Joshua Sabari is scheduled for 8:00 am ET today.
At the time of this announcement, ORIC was trading at $13.85 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 news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.