Summary of ORIC Pharmaceuticals Conference Call Company Overview - **Company**: ORIC Pharmaceuticals (NasdaqGS:ORIC) - **Focus**: Development of ORIC-114 for non-small cell lung cancer (NSCLC) patients with EGFR mutations Key Industry Insights - **Target Population**: Patients with EGFR exon 20 and EGFR PACC mutations, which occur annually in approximately 9,000 patients in the U.S. alone [6] - **Market Opportunity**: There is currently one FDA-approved therapy for first-line EGFR exon 20 and none for EGFR PACC mutation, indicating a significant unmet need in these populations [6] Core Findings from ORIC-114 Program Update - **Clinical Data**: ORIC-114 has shown highly competitive response rates in both pre-treated and front-line settings for EGFR exon 20 and EGFR PACC mutations [42] - **CNS Activity**: ORIC-114 demonstrates profound CNS activity, critical due to the high prevalence of brain metastases in these populations [5][42] - **Safety Profile**: The drug has a lack of significant off-target toxicities, such as cardiac, hepatic, and hematological liabilities, which are common with competitor inhibitors [5][42] Clinical Trial Highlights - **Phase 1b Study**: Conducted at 39 major academic centers across 10 countries, enrolling over 300 patients [16] - **Preferred Dose**: 80 mg once daily has been selected as the preferred dose for future development based on safety and efficacy observations [5][42] - **Efficacy Results**: - **Second-line Cohort**: 45% confirmed objective response rate (ORR) at 80 mg, with a 100% disease control rate [21] - **First-line Cohort**: 67% ORR with a 93% disease control rate, demonstrating strong efficacy even in patients with brain metastases [26] - **CNS-specific Responses**: 100% intracranial ORR in patients with measurable CNS disease [28] Important Considerations - **Patient Enrollment**: Unlike competitors, ORIC allowed enrollment of patients with active brain metastases from the beginning of the trial, reflecting confidence in ORIC-114's CNS penetrance [59] - **Regulatory Insights**: The FDA prefers to see CNS activity demonstrated in patients with active and measurable brain metastases, which ORIC-114 has achieved [62] - **Future Development**: Plans to continue enrollment and long-term follow-up in frontline populations, with the next update expected in mid-2026 ahead of potential phase 3 trials [42] Conclusion - ORIC-114 is positioned as a potential best-in-class treatment for patients with EGFR-mutated NSCLC, with strong clinical data supporting its efficacy and safety profile, particularly in addressing CNS metastases [42][57]

Oric Pharmaceuticals (NasdaqGS:ORIC) Update / Briefing December 06, 2025 08:00 PM ET Speaker2Good day, and thank you for standing by. Welcome to the ORIC ORIC-114 Program Update conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising that your hand has been raised. To withdraw ...