ORIC Initiates Dosing in Phase 1b Expansion for ORIC-114 in NSCLC Patients with Specific Mutations

April 15, 2024 — ORIC Pharmaceuticals, a clinical-stage oncology company, has completed the dose escalation phase of its Phase 1b trial for ORIC-114, a treatment for advanced solid tumors with specific EGFR and HER2 exon 20 alterations or HER2 amplifications. The company has since initiated multiple Phase 1b expansion cohorts to establish the recommended Phase 2 dose (RP2D) for ORIC-114 in non-small cell lung cancer (NSCLC) patients with EGFR exon 20, HER2 exon 20, or EGFR atypical mutations. Additionally, an extension cohort has been launched to assess the drug's potential in treating first-line, treatment-naïve EGFR exon 20 NSCLC patients. 

ORIC-114 has demonstrated a promising profile in the dose escalation phase, showing notable systemic and CNS responses alongside a favorable safety profile in heavily pre-treated patients. The company has selected two provisional RP2D levels, 80 mg and 120 mg QD, for further evaluation. The Phase 1b expansion aims to assess the safety, efficacy, and optimal dosing of ORIC-114, with an emphasis on objective response rate, duration of response, progression-free survival, and intracranial activity. 

ORIC-114 is an orally bioavailable, irreversible inhibitor designed to target EGFR and HER2 with high potency against exon 20 insertion mutations, potentially offering significant systemic and CNS antitumor activity. The company anticipates reporting updated Phase 1b data in the first half of 2025. 

ORIC Pharmaceuticals is committed to developing treatments that overcome therapeutic resistance in cancer. Its pipeline includes ORIC-114, ORIC-944, an allosteric inhibitor of the PRC2 complex for prostate cancer, and ORIC-533, an inhibitor of CD73 for multiple myeloma. The company is advancing multiple precision medicines targeting cancer resistance mechanisms and maintains a presence in South San Francisco and San Diego, California.

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