Olema Oncology unveils a fresh clinical trial collaboration with Pfizer, aiming to blend Palazestrant with Atirmociclib for treating metastatic breast cancer that is ER+/HER2-
In a significant development for the treatment of metastatic breast cancer, Olema Oncology has announced a new clinical trial in collaboration with Pfizer Inc. The trial, set to commence in the second half of 2025, will investigate the combination of Palazestrant and Atirmociclib in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer.
Olema Oncology, a clinical-stage biopharmaceutical company based in San Francisco and Cambridge, Massachusetts, will lead the study, while Pfizer will provide Atirmociclib. The trial is anticipated to be a Phase 1b2 study, evaluating the safety and combinability of palazestrant plus atirmociclib in the specified patient population.
Sean P. Bohen, M.D., Ph.D., serves as the President and Chief Executive Officer of Olema Oncology. The company's lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD). Palazestrant has demonstrated anti-tumor efficacy, attractive pharmacokinetics, favorable tolerability, central nervous system penetration, and combinability with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors.
The trial results could inform a potential pivotal Phase 3 trial of the novel combination in the frontline metastatic breast cancer setting. This is not the first collaboration between Olema Pharmaceuticals, Inc. and Pfizer Inc., as their previous agreement was established in November 2020.
Palazestrant is currently being investigated as a single agent in the ongoing pivotal Phase 3 clinical trial, OPERA-01, and is also anticipated to be evaluated in combination with ribociclib in the planned pivotal Phase 3 clinical trial, OPERA-02. Olema remains committed to improving outcomes for patients living with breast cancer and beyond.
In addition to palazestrant, Olema Oncology is developing OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor, now in a Phase 1 clinical study. The clinical data and inventions relating to the combined use of atirmociclib and palazestrant will be jointly owned.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Palazestrant for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. This designation is intended to facilitate the development and expedite the review of drugs that are intended to treat serious conditions and fill an unmet medical need.
The collaboration between Olema Oncology and Pfizer Inc. marks an exciting step forward in the pursuit of effective treatments for metastatic breast cancer. As the trial progresses, we can look forward to further updates on the potential benefits of this novel combination for patients.
