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SABCS 2022 | Preliminary data on OP-1250 + palbociclib in advanced/metastatic ER+/HER- breast cancer

Sean Bohen, MD, PhD, Olema Oncology, San Francisco, CA, shares preliminary data from a Phase Ib (NCT04505826) dose escalation study of OP-1250, an oral CERAN, in combination with palbociclib in patients with advanced and/or metastatic estrogen receptor (ER)-positive, HER2-negative breast cancer. Monotherapy is well tolerated, and the recommended phase 2 dose is 120 mg QD. The aim of this combination trial is to define the maximum tolerated dose (MTD), safety, tolerability, and pharmacokinetics of OP-1250 in combination with palbociclib. In the first three cohorts of OP-1250 and palbociclib, the combination was well tolerated and no dose limiting toxicities occurred. The next steps for OP-1250 is to commence a Phase III trial in the second or third-line setting. Enrolment of the Phase II study is complete, the data of which will be presented in the first half of the next year. In combination with palbociclib, a Phase II dose expansion trial is underway, the data of which is expected in the following year. This interview took place at the San Antonio Breast Cancer Symposium (SABCS) 2022 in San Antonio, TX.

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