Olema Oncology Announces Palazestrant Dose Selection and Trial-in-Progress Poster at ASCO 2025 Annual Meeting

Core Insights - Olema Pharmaceuticals has aligned with the FDA to select a 90 mg dose of palazestrant for the Phase 3 OPERA-01 trial in ER+/HER2- metastatic breast cancer [1][2] - The OPERA-01 trial results are expected to be presented at the ASCO Annual Meeting from May 30 to June 3, 2025, with top-line data anticipated in 2026 and a potential commercial launch in 2027 [2][4] Company Overview - Olema Oncology is a clinical-stage biopharmaceutical company focused on developing targeted therapies for breast cancer, particularly through its lead product candidate, palazestrant (OP-1250) [4][5] - Palazestrant is a novel small molecule that acts as both a complete estrogen receptor antagonist and a selective estrogen receptor degrader, currently being evaluated in multiple clinical trials [3][5] Clinical Trials - The OPERA-01 trial is a randomized, open-label Phase 3 study comparing palazestrant monotherapy to standard endocrine therapy for patients with advanced ER+/HER2- breast cancer [2][4] - Palazestrant has received FDA Fast Track designation for treating ER+/HER2- metastatic breast cancer that has progressed after endocrine therapy and at least one line of treatment with a CDK4/6 inhibitor [3][4]