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Olema Oncology Announces OP-1250 Continues to Demonstrate Attractive Combinability with CDK4/6 Inhibitor Palbociclib in Phase 1b/2 Study
OP-1250 in combination with palbociclib was well-tolerated in patients with ER+/HER2- metastatic breast cancer, with no dose-limiting toxicities, and no
About this update from Olema Pharmaceuticals, Inc.
[{"type":"text","content":"OP-1250 in combination with palbociclib was well-tolerated in patients with ER+/HER2- metastatic breast cancer, with no dose-limiting toxicities, and no observed drug-drug interaction Overall tolerability profile of the combination is consistent with the FDA-approved label of palbociclib plus an endocrine agentTumor responses have been observed in patients previously treated with CDK4/6 inhibitors SAN FRANCISCO, May 11, 2023 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema”, “Olema Oncology”, or the “Company”, Nasdaq: OLMA) today announced interim results from an ongoing Phase 1b/2 clinical study of OP-1250, the Company’s complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD), in combination with palbociclib, a CDK4/6 inhibitor, for the treatment of ER+/HER2- metastatic breast cancer. These results, as of March 8, 2023, were presented today in a poster session at the 2023 ESMO Breast Cancer Annual Congress in Berlin, Germany. The poster, titled “A Phase 1b/2 Study of OP-1250, an Oral Complete Estrogen Receptor Antagonist (CERAN) and Selective ER Degrader (SERD) with Palbociclib in Patients with Advanced or Metastatic HR+/HER2- Breast Cancer”, highlighted that: Across 29 patients, the combination of up to 120 mg of OP-1250 with 125 mg of palbociclib is safe and well-tolerated with no drug-drug interaction (DDI), no induced metabolism of palbociclib, and exposure of both palbociclib and OP-1250 in combination with each other was consistent with the observed monotherapy exposure levels.No dose-related increases in the incidence, severity, or timing of adverse events were observed, and neutropenia events observed were consistent with the expected profile of palbociclib plus endocrine therapy.Tumor responses and prolonged disease stabilization were observed in this group of patients, including in those previously exposed to palbociclib and other CDK4/6 inhibitors. “We are very pleased with our emerging combination clinical results of OP-1250 with palbociclib,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “The findings presented today support the potential for OP-1250 to become a best-in-class endocrine therapy in the first-line treatment of ER+/HER2- metastatic breast cancer. OP-1250, in combination with palbociclib, did not display the drug-drug interac...