ORIC Pharmaceuticals Announces First Patients Dosed Across Three Expansion Cohorts in Phase 1b Trial of ORIC-114 in Patients with Mutated NSCLC

Initiated multiple Phase 1b expansion cohorts to determine the RP2D of ORIC-114 in NSCLC patients with EGFR exon 20, HER2 exon 20, or EGFR atypical mutations

Additionally, the company initiated an extension cohort to evaluate ORIC-114 for the treatment of patients with first-line, treatment-naïve EGFR exon 20 NSCLC

Expect to report updated Phase 1b data in the first half of 2025

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, April 15, 2024 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced the completion of the dose escalation portion of the Phase 1b trial of ORIC-114 in patients with advanced solid tumors with EGFR and HER2 exon 20 alterations or HER2 amplifications. Based upon these data, ORIC selected the two provisional recommended Phase 2 dose (RP2D) levels of ORIC-114 at 80 mg and 120 mg QD, which are being further evaluated in three dose expansion cohorts for dose optimization and final RP2D selection. These expansion cohorts have now been initiated in patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 (EGFR exon 20 inhibitor naïve), HER2 exon 20, or EGFR atypical mutations. The company also announced the initiation of an extension cohort for the treatment of patients with first-line, treatment-naïve EGFR exon 20 NSCLC.

“Following the positive dose escalation data reported at ESMO 2023, we are excited to announce the advancement of ORIC-114 into Phase 1b dose expansion,” said Pratik Multani, M.D., chief medical officer of ORIC. “Encouraging findings from the Phase 1b dose escalation phase of the trial demonstrated a potential best-in-class profile for ORIC-114, with notable systemic responses and CNS responses, as well as a favorable safety profile, in heavily pre-treated patients. Based on these results, we have identified the two dose levels that we are now advancing into Phase 1b expansion cohorts to determine the final RP2D for further development, including potential registrational cohorts. At the request of many of our investigators and because of the lack of other CNS-active agents against EGFR exon 20, we are also extending our trial to include a cohort evaluating first-line, treatment-naïve NSCLC. We are hopeful that the expansion portion of the trial will validate and build upon the encouraging efficacy seen in the dose escalation, and plan to report results in the first half of 2025.”