News & Events zu Oric Pharmaceuticals Inc (ORIC)ORICOric Pharmaceuticals Inc

Oric Pharmaceuticals Plans to Initiate Global Phase 3 Trial in 2027

Oric Pharmaceuticals presented data for enozertinib in first-line NSCLC patients with EGFR atypical mutations at ESMO Congress 2026 and announced plans to advance enozertinib into a global Phase 3 trial. Enozertinib is being evaluated in an ongoing Phase 1b trial in patients with locally advanced or metastatic NSCLC with EGFR atypical and EGFR exon 20 insertion mutations. Notably, enrollment allows patients with previously untreated brain metastases. Key objectives of the trial included safety and determination of the recommended Phase 2 dose, along with assessment of antitumor activity based on investigator-assessed objective response rate, or ORR, blinded independent central review, or BICR-assessed ORR, CNS-ORR according to modified RECIST 1.1 and/or Response Assessment in Neuro-Oncology Brain Metastases, as well as DOR and PFS. As of the September 4 cutoff date, data are presented for 26 patients who were treated with 80 mg once daily oral enozertinib, including 23 patients with P-loop and alpha C-helix compressing mutations and three patients with L861Q mutations without a co-occurring PACC mutation. Brain metastases were present in 65% of patients at baseline, which is more than double the rate versus competitor datasets. Notably, 46% of all patients had previously untreated brain metastases. Enozertinib was well tolerated with predominantly Grade 1 or 2 treatment-related adverse events. or TRAEs, and no significant off-target toxicities. Most frequent TRAEs included diarrhea, paronychia, and dermatitis acneiform. Six patients experienced Grade 3 TRAEs, all of which were resolved with dose modifications. There were no Grade 4 or 5 TRAEs and no treatment discontinuations related to TRAEs. Tumor reductions were observed across all response-evaluable patients. Reductions were also observed across a wide range of mutations, including the most prevalent PACC mutations, a broad spectrum of PACC complex mutations, and L861Q mutations. Enozertinib demonstrated meaningful systemic activity, including: 84% confirmed systemic ORR by investigator, 80% confirmed systemic ORR by BICR. Deep EGFR-mutant ctDNA molecular responses were achieved by Cycle 3 Day 1 in all response-evaluable patients across diverse mutations: 100% of patients achieved MR90, defined as a 90% EGFR-mutant ctDNA reduction, 82% of patients achieved full clearance, which has been associated with improved long-term survival outcomes in prior Phase 3 NSCLC trials. Enozertinib continues to demonstrate intracranial efficacy. Notably, no new CNS lesions were observed in patients with or without baseline CNS metastases. All response-evaluable patients with measurable CNS disease achieved CNS tumor reductions per investigator-assessment. Enozertinib demonstrated compelling intracranial activity, including: 70% confirmed intracranial ORR by investigator. Intracranial efficacy was also evaluated utilizing the more stringent BICR RANO-BM assessment criteria. Based on this assessment, CNS tumor reductions were observed in nearly all response-evaluable patients, including in patients with previously untreated CNS metastases4. Enozertinib demonstrated compelling intracranial activity, including: 67% intracranial ORR by BICR RANO-BM, 40% intracranial complete response rate by BICR RANO-BM, including in three patients with non-measurable CNS disease. Median progression-free survival and median duration of response data are immature. The Kaplan-Meier 6-month landmark PFS is 88%. Follow-up is ongoing with the majority of patients continuing on treatment. Supported by potential best-in-class data presented at ESMO Congress 2026 and based on End-of-Phase 1 interactions with the FDA, ORIC plans to initiate Redwood-1, a global Phase 3 registrational trial in EGFR atypical NSCLC in 1H 2027. This trial plans to enroll approximately 360 patients with PACC and L861X mutations, including those with untreated brain metastases, randomized to receive 80 mg once daily oral enozertinib or physician's choice of osimertinib or afatinib. Dual primary endpoints include ORR by BICR for potential accelerated approval as well as PFS by BICR for full approval. Key secondary endpoints include overall survival and intracranial ORR by BICR RANO-BM.

Oric Pharmaceuticals Highlights Rinzimetostat's Potential in Prostate Cancer

Oric Pharmaceuticals announced preclinical and translational data from an ePoster presentation at ESMO Congress 2026 highlighting the potential of rinzimetostat to enhance sensitivity to androgen receptor inhibition in prostate cancer. Preclinical results suggest potential advantages of targeting PRC2 via EED with rinzimetostat over targeting EZH2: Prostate cancer cells that rapidly developed resistance to mevrometostat acquired a mutation in EZH2 against which rinzimetostat potency was maintained; no emergence of rinzimetostat-resistant cells was observed. No hematologic tumorigenesis was observed in the rinzimetostat rat toxicology study, in contrast to rat tumorigenesis demonstrated with EZH2 inhibitor tazemetostat; these results are consistent with mouse genetic studies of PRC2 components and suggest the tumorigenesis risk may be elevated with selective EZH2 targeting. Comparative preclinical studies demonstrated drug properties supporting rinzimetostat's potential profile, including favorable solubility, oral bioavailability, half-life and CYP profile. Rinzimetostat restored access to AR binding motifs and restricted accessibility at sites associated with lineage plasticity in preclinical prostate cancer models, supporting a mechanism that reinforces AR dependence and limits tumor adaptation. Rinzimetostat synergized with AR inhibition in preclinical prostate cancer studies. KLK2 and STEAP1 luminal markers increased following rinzimetostat treatment in preclinical studies. Samples from patients with mCRPC treated with single-agent rinzimetostat demonstrated biological changes consistent with the preclinical findings: Plasma cfDNA methylation profiling showed epigenetic shifts indicative of increased AR signaling after one treatment cycle in most patients assessed. Paired tumor biopsies showed increased levels of luminal and AR-associated markers PSMA and KLK2.

Nasdaq Hits Record Highs, S&P 500 Up 0.7%

Broad-based strength in the mega-cap tech space - in spite of continued upward pressure in Treasury yields - helped the Nasdaq Composite to fresh record highs on Monday and also lifted S&P 500 by 0.7%. Among the Mag-7, Nvidia, Metaand Teslawere up by about 2%. Computer Hardware stocks like Seagateand Western Digitalwere also notably higher, rising 4% and 6%, respectively. Rate sensitive sectors lagged, with Real Estate and Utilities finishing the day as the two worst performing areas of the market as the yield on the 10-year benchmark closed at the highs and above 5.3% for the first time since 2002.In the opening hour of the evening session, S&P e-minis and Nasdaq 100 contracts are up by about a decimal. WTI Crude Oil is down for the third straight session to trade below $90 per barrel as more constructive reports of traffic navigating the Strait of Hormuz and reports of a G7 supply release supercede the absence of a U.S.-Iran resolution.Check out this evening's top movers from around Wall Street, compiled by The Fly.HIGHER -Option Care Healthup 21.0% after FT report company is under takeover interest from McKesson and PE partnerFreshworksup 4.3% after admission into S&P SmallCap 600 indexLeonardo DRSup 1.8% after completing training, delivery for INOD Block III to Australian ArmyXenon Pharmaceuticalsup 1.7% after being started with Buy at GuggenheimORIC Pharmaceuticalsup 1.5% after entering pact with Cancer Research UK to advance ORIC-259Pinterestup 1.0% after naming new CFOLOWER -NeoGenomicsdown 3.1% after Q3 pre-announcement, CEO transitionTORM plcdown 1.4% after equity offering