Initial Phase 1 Dose Escalation Data of ORIC-114 in Patients with EGFR and HER2 Exon 20 Mutations Demonstrates Potential Best-In-Class Profile

CNS activity observed at multiple dose levels, including the first reported confirmed CNS complete response by an EGFR exon 20 inhibitor in a patient with documented untreated brain metastases

Systemic responses observed at multiple dose levels in heavily pre-treated NSCLC patients, characterized by 81% having received prior EGFR exon 20 targeted agents and 86% having CNS metastases at baseline

At potential RP2D of 75 mg QD, responses observed in 2 of 3 EGFR exon 20 patients previously treated with amivantamab (67% ORR), including a confirmed complete response

Responses observed at multiple dose levels in HER2 exon 20 patients, including a partial response with 100% target lesion regression

Favorable safety profile with mainly Grade 1 and 2 treatment related adverse events; MTD not reached and dose escalation remains ongoing

Company to host conference call and webcast today at 9:00 am ET

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Oct. 21, 2023 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced initial data from the ongoing ORIC-114 Phase 1 dose escalation trial for patients with EGFR or HER2 exon 20 mutated non-small cell lung cancer (NSCLC) at the European Society of Medical Oncology (ESMO) Congress 2023 (clinical poster here).

“We are excited to present the first look at ORIC-114 clinical data, which we believe supports the potential to address the key attributes of a potential best-in-class program for EGFR/HER2 exon 20 mutated NSCLC: minimal EGFR toxicity, minimal off-target toxicity, CNS activity, and systemic activity including post-amivantamab,” said Jacob M. Chacko, MD, chief executive officer. “Given the high rate of brain metastases in these patients and the high percentage of patients whose disease progresses in the brain, we believe that a well-tolerated CNS active agent has the potential to be transformative.”

“We are pleased with the emerging profile of ORIC-114 in these heavily pretreated patients, which includes clinical activity across multiple dose levels and the first reported intracranial complete response in a patient with EGFR exon 20 lung cancer and documented untreated brain metastases,” said Pratik Multani, MD, chief medical officer. “This is the first comprehensive data set for EGFR exon 20 patients with such an exceptionally high rate of CNS disease at baseline and prior exon 20 inhibitor therapy. Based on the encouraging clinical activity and favorable safety profile, we plan to advance this program into dose optimization to select RP2D and, ultimately, into one or more registrational cohorts for potential accelerated approval.”