Olema Oncology Announces Expansion of Collaboration Agreement with Novartis

Olema Pharmaceuticals, a clinical-stage biopharmaceutical company focused on developing targeted therapies for women’s cancers, has announced an amendment to its clinical collaboration and supply agreement with Novartis Institutes for BioMedical Research. The amendment increases the size of the ongoing Phase 1/2 clinical study testing palazestrant in combination with ribociclib to approximately 60 patients.

This expanded study is a significant step towards supporting the potential late-stage development of palazestrant in first-line advanced or metastatic breast cancer in combination with ribociclib. With the Phase 1b dose escalation portion successfully completed, Olema is now in Phase 2 dose expansion at the 120 mg dose of palazestrant in combination with 600 mg of ribociclib.

Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology, expressed his enthusiasm for the expanded study, stating that it now has the potential to generate a clinical dataset sufficient to support the regulatory pathway for a first-line pivotal trial.

The clinical collaboration and supply agreement between Olema and Novartis, initially signed in July 2020 and amended in January 2022, focuses on evaluating the safety, tolerability, and efficacy of palazestrant in combination with Novartis’ proprietary cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor ribociclib and/or Novartis’ proprietary phosphatidylinositol 3-kinase (PI3Ka) inhibitor alpelisib in patients with metastatic ER+ breast cancer.

The amendment adds approximately 30 patients to be enrolled in the cohort expansion phase of the palazestrant clinical study in combination with ribociclib. This increased patient enrollment will provide valuable data to further assess the potential of palazestrant as a treatment option for patients with advanced or metastatic breast cancer.

Palazestrant (OP-1250), Olema’s lead product candidate, is a proprietary, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist and a selective ER degrader. It is currently being evaluated as a single agent in an ongoing Phase 2 clinical trial and in combination with CDK4/6 inhibitors (palbociclib and ribociclib) and a PI3Ka inhibitor (alpelisib) in patients with recurrent, locally advanced, or metastatic ER-positive, human epidermal growth factor receptor 2-negative breast cancer.

The 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.

Olema Oncology is headquartered in San Francisco and has operations in Cambridge, Massachusetts. The company is dedicated to advancing innovative therapies for women’s cancers and is committed to improving the lives of patients through its research and development efforts.

With the amended clinical collaboration and supply agreement, Olema and Novartis are further strengthening their partnership to explore the potential of palazestrant in combination with ribociclib for the treatment of metastatic ER+ breast cancer. This collaboration highlights the importance of developing targeted therapies that can provide new treatment options and improved outcomes for patients facing this challenging disease.

For more information about Olema Oncology and its ongoing research and development efforts, please visit their website or follow them on Twitter and LinkedIn.