ORIC Pharmaceuticals Presents Potential Best-in-Class Profile for Enozertinib with Robust Systemic and CNS Activity in 1L and 2L NSCLC Patients with EGFR Exon 20 Mutations at the ESMO Asia Congress 2025

Highly differentiated 1L preliminary systemic activity of 67% ORR and 100% intracranial ORR (by BICR-RANO), including in patients with active brain metastases

45% ORR in 2L patients exceeds competitor benchmarks

Competitive safety profile, with no significant off-target toxicity and manageable on-target toxicity, resulting in low discontinuation rate

Enrollment and follow-up continue in 1L patients at selected dose of 80 mg once daily,
with next update expected mid-2026 ahead of initiation of potential Phase 3 trial

Company to host a conference call and webcast on Saturday, December 6, 2025, at 8:00 pm ET

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Dec. 05, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, announced data from a Phase 1b trial of enozertinib (ORIC-114) at the ESMO Asia Congress 2025. Data in treatment-naïve and in previously treated NSCLC patients with EGFR exon 20 mutations were presented at an oral session, and the presentation can be found in the publication section of ORIC’s website here.

“Enozertinib was purposefully designed to be highly brain-penetrant and exquisitely selective in order to address the limitations of available therapies and potentially drive differentiated durability. These data provide clinical support for this design approach, demonstrating strong systemic and CNS activity in NSCLC patients with EGFR exon 20 mutations,” said Pratik S. Multani, M.D., chief medical officer. “The profile we have seen with enozertinib compares favorably to other approved and investigational therapies and continues to support enozertinib’s best-in-class potential.”

Enozertinib Phase 1b Trial Design
Enozertinib is being evaluated in a Phase 1b trial in patients with locally advanced or metastatic NSCLC with EGFR exon 20 mutations. Notably, enrollment allows patients with active untreated brain metastases. Prior therapy in 2L patients consisted of platinum-based chemotherapy. The primary endpoint of the trial is to determine the recommended Phase 2 dose (RP2D), and secondary endpoints include investigator-assessed objective response rate (ORR), CNS response rate by blinded independent central review (BICR) using response assessment in neuro-oncology (RANO) criteria in treatment-naïve patients, disease control rate (DCR), and safety.