Pfizer and Olema Pharmaceuticals Collaborate on Breast Cancer Treatment Trial

Olema Pharmaceuticals and Pfizer have partnered for a clinical trial of a breast cancer treatment. Pfizer is the world's leading pharmaceutical group with a portfolio of products including primary care, specialty care, oncology, and other products. The United States accounts for 60.8% of Pfizer's net sales.

Olema Pharmaceuticals, Inc. (OLMA) and Pfizer Inc. (PFE) have announced a new clinical trial collaboration to evaluate the combination of palazestrant and atirmociclib in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer. The study, a Phase 1b/2 trial, is expected to commence in the second half of 2025 and will involve approximately 35 patients [1].

The trial aims to assess the safety and combinability of palazestrant, an orally available complete estrogen receptor (ER) antagonist and selective ER degrader (SERD), and atirmociclib, Pfizer’s investigational, highly selective CDK4 inhibitor. The results of this study will inform the potential development of a pivotal Phase 3 trial for the novel combination in the frontline metastatic breast cancer setting.

Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology, expressed enthusiasm about the collaboration: "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. Based on the promising profiles of palazestrant and atirmociclib to date, we look forward to evaluating the potential of this novel combination and, if successful, advancing to a pivotal trial in the frontline setting" [1].

Under the terms of the agreement, Pfizer will supply atirmociclib for use in the Phase 1b/2 study, while Olema will lead the conduct of the study. All clinical data and inventions resulting from the study will be jointly owned, with Olema maintaining full global commercial and marketing rights to palazestrant. This collaboration marks Olema’s second clinical trial agreement with Pfizer, following their previous agreement in November 2020 to evaluate palazestrant in combination with palbociclib (IBRANCE®) in patients with recurrent, locally advanced or metastatic ER+/HER2- breast cancer [1].

Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. The company’s lead product candidate, palazestrant (OP-1250), is currently in a Phase 3 clinical trial called OPERA-01. Additionally, Olema is developing OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor, which is currently in a Phase 1 clinical study [1].

Pfizer, the world's leading pharmaceutical group, has a portfolio of products including primary care, specialty care, oncology, and other products. The United States accounts for 60.8% of Pfizer's net sales [2].

References:
[1] https://www.morningstar.com/news/globe-newswire/9520730/olema-oncology-announces-new-clinical-trial-agreement-with-pfizer-to-combine-palazestrant-with-atirmociclib-in-erher2-metastatic-breast-cancer
[2] https://finance.yahoo.com/news/olema-oncology-announces-clinical-trial-110000111.html