Olema Oncology partners with Pfizer for breast cancer drug trial

Olema Pharmaceuticals Inc. (NASDAQ: OLMA) announced a clinical trial collaboration with Pfizer Inc. (NYSE: PFE) to evaluate a drug combination for metastatic breast cancer treatment.

The Phase 1b/2 study will test the safety and effectiveness of combining Olema's palazestrant with Pfizer's atirmociclib in approximately 35 patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer. The trial is expected to begin in the second half of 2025.

Under the agreement, Pfizer will supply atirmociclib while Olema leads the study conduct. Clinical data and inventions from the combined drug use will be jointly owned, with Olema retaining full commercial and marketing rights to palazestrant.

"We are excited to assess this combination in the clinic as we seek to establish palazestrant as a potential backbone endocrine therapy for metastatic breast cancer," said Sean Bohen, Olema's chief executive officer. The results will inform a potential Phase 3 trial of the combination in frontline metastatic breast cancer treatment.

This marks Olema's second clinical collaboration with Pfizer. The companies previously agreed in November 2020 to evaluate palazestrant combined with palbociclib in patients with recurrent or metastatic breast cancer.

Palazestrant is currently being tested as a single agent in the ongoing Phase 3 OPERA-01 trial. Olema also plans to initiate the OPERA-02 trial combining palazestrant with ribociclib in frontline metastatic breast cancer treatment this quarter.

The drug has received FDA Fast Track designation for treating metastatic breast cancer that has progressed following endocrine therapy combined with CDK4/6 inhibitors.

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