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Olema Oncology Announces First Clinical Data on OP-1250 in Advanced ER+ / HER2- Breast Cancer
Successful completion of dose-escalation stage of ongoing Phase 1/2 clinical study; OP-1250 demonstrated highly attractive pharmacokinetics, favorable
About this update from Olema Pharmaceuticals, Inc.
[{"type":"text","content":"Successful completion of dose-escalation stage of ongoing Phase 1/2 clinical study; OP-1250 demonstrated highly attractive pharmacokinetics, favorable tolerability, and clear efficacy signalsRobust anti-tumor activity, including three partial responses (two confirmed and one unconfirmed) and up to 100% target lesion reduction, observed in a heavily pretreated patient populationOverall Response Rate of 17% and Clinical Benefit Rate of 46% in recommended Phase 2 dose range; Efficacy data continues to mature with 32% of patients still on studyRapidly advancing clinical development program with dose expansion ongoing; Phase 2 monotherapy and first CDK4/6 inhibitor combination studies to initiate in Q1 2022Company to host investor conference call today at 8:30 a.m. ET SAN FRANCISCO, Nov. 30, 2021 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, today announced the first clinical data from the Phase 1 dose-escalation portion of the ongoing Phase 1/2 clinical trial of OP-1250, a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD) in development for the treatment of metastatic breast cancer and other women’s cancers. Data as of October 1, 2021, is scheduled to be presented in a poster presentation at the San Antonio Breast Cancer Symposium (SABCS), taking place December 7-10, 2021. Updated data as of November 1, 2021, are detailed below. These initial data provide strong proof-of-concept for OP-1250 as a once-daily oral monotherapy in women with recurrent, locally advanced or metastatic ER+ / HER2- breast cancer and demonstrate OP-1250’s potential to become a best-in-class endocrine therapy. In the trial, OP-1250 showed highly attractive pharmacokinetics supporting once-daily dosing, favorable tolerability, and clear evidence of anti-tumor activity. Three partial responses (2 confirmed, 1 unconfirmed) and robust target lesion reduction up to 100% were observed in a heavily pretreated patient population. In the recommended Phase 2 dose (RP2D) range of 60-120 mg OP-1250 once daily, the overall response rate (ORR) was 17% and the clinical benefit rate (CBR) was 46%. “We successfully delivered on our objectives for the d...