Olema Pharmaceuticals, Inc. ((OLMA)) announced an update on their ongoing clinical study.
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Olema Pharmaceuticals, Inc. is conducting a Phase 3 clinical trial, titled ‘A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01).’ The study aims to evaluate the safety and efficacy of palazestrant (OP-1250) compared to standard-of-care treatments like fulvestrant or aromatase inhibitors in patients with advanced breast cancer. This research is significant as it explores new treatment options for patients who have progressed on existing therapies.
The intervention being tested is palazestrant (OP-1250), an experimental drug administered daily in a 28-day cycle. It is designed to provide an alternative to current standard treatments, which include drugs like fulvestrant, anastrozole, letrozole, and exemestane.
The study is interventional, with a randomized allocation and a parallel intervention model. It is open-label, meaning no masking is involved, and its primary purpose is treatment-focused.
The study began on August 17, 2023, and is currently recruiting participants. The primary completion and estimated completion dates are not specified, but the last update was submitted on August 22, 2025. These dates are crucial for tracking the study’s progress and potential market entry.
This update could impact Olema Pharmaceuticals’ stock performance positively, as successful trial results may enhance investor confidence and market position. The study also positions Olema competitively within the oncology sector, where advancements in breast cancer treatment are highly valued.
The study is ongoing, with further details available on the ClinicalTrials portal.