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Olema Oncology Advances OP-1250 into Phase 2 Monotherapy Expansion in Patients with ER+/HER2- Advanced Breast Cancer

Excerpt from the Press Release:

SAN FRANCISCO, Aug. 09, 2022 (GLOBE NEWSWIRE) — Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq: OLMA), today announced the advancement of OP-1250, a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD), into Phase 2 clinical development for the treatment of ER+/HER2- metastatic breast cancer.

“We are excited about the potential of OP-1250 and are expeditiously advancing the development program as we work to further position OP-1250 as a differentiated CERAN and potential endocrine therapy of choice for ER+ breast cancer.” said Naseem Zojwalla, M.D., Chief Medical Officer of Olema Oncology. “Enrollment is underway in Phase 2 monotherapy, and we look forward to further evaluating OP-1250’s benefit in treating ER+/HER2- breast cancer patients.”

Selection of the recommended Phase 2 dose (RP2D) of 120 mg OP-1250 once-daily was based on pharmacokinetics, safety and tolerability, and encouraging early anti-tumor activity from Phase 1b expansion, which evaluated both 60 mg and 120 mg dose cohorts. As of July 1, 2022, a total of 50 patients had been treated in Phase 1b expansion (N=25 for each cohort).

  • Pharmacokinetic analyses demonstrated dose-proportional exposure of OP-1250, high oral bioavailability, and steady-state plasma levels with minimal peak-to-trough variability.
  • The majority of reported adverse events were Grade 1 or 2 at both dose levels, and the most common treatment-emergent adverse events occurring in ≥10% of patients were nausea, vomiting, fatigue, and headache, which were similar across both doses.​

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