ORIC Pharmaceuticals Initiates First Patients in Three Expansion Cohorts for Phase 1b Trial of ORIC-114 in Mutated NSCLC
15 April 2024
ORIC Pharmaceuticals, Inc. has completed the dose escalation phase of the Phase 1b trial for ORIC-114, a treatment targeting advanced solid tumors with EGFR and HER2 exon 20 alterations or HER2 amplifications. Two recommended Phase 2 dose levels of ORIC-114 have been selected for further evaluation: 80 mg and 120 mg QD. These doses are currently being assessed in three expansion cohorts to refine dosing and select the final recommended Phase 2 dose.
Expansion cohorts have started for patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 mutations (naïve to EGFR exon 20 inhibitors), HER2 exon 20 mutations, or EGFR atypical mutations. Additionally, an extension cohort has been initiated for treating patients with first-line, treatment-naïve EGFR exon 20 NSCLC.
Dr. Pratik Multani, Chief Medical Officer of ORIC, expressed excitement about advancing ORIC-114 into Phase 1b dose expansion. Notable systemic and CNS responses, along with a favorable safety profile, were observed in heavily pre-treated patients during the Phase 1b dose escalation phase. Dr. Multani highlighted the importance of these findings in selecting the doses for further development and potential registrational cohorts.
The Phase 1b dose escalation evaluated ORIC-114 in advanced solid tumor patients with specific genetic alterations, including those with CNS metastases. Unlike many other trials targeting EGFR exon 20, this trial included patients with active or untreated brain metastases and those previously treated with an EGFR exon 20 inhibitor.
Moving forward, the Phase 1b expansion will assess the safety and efficacy of ORIC-114 at the selected doses in mutated NSCLC patients, focusing on objective response rate, duration of response, and progression-free survival. ORIC-114, designed as a highly selective, brain-penetrant, orally bioavailable inhibitor, holds promise in addressing the unmet medical need for both systemic and CNS antitumor activity, particularly against EGFR and HER2 exon 20 mutations.
Source: globenewswire.com