Olema Pharma Says Lead Candidate Robust Activity In Breast Cancer Patients

Olema Pharmaceuticals Inc OLMA announced preliminary clinical results from a Phase 1/2 study of OP-1250, a complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD) for metastatic breast cancer.
Across 68 patients at 60 mg and 120 mg once daily oral dosing, OP-1250 was well tolerated with attractive pharmacokinetics (PK) and drug exposure levels approximately 20 times that of fulvestrant at the 120 mg dose.
Related: After Denying Data Leak, Olema Shares First Data For Lead Program In Breast Cancer Patients.
OP-1250 demonstrated strong anti-tumor activity and durable benefit, with 41% of patients seeing reductions in target tumor lesions and six partial responses (4 confirmed and 2 unconfirmed) out of 57 efficacy-evaluable patients.
Treatment with OP-1250 was well tolerated at both the 60 mg and 120 mg dose levels with no dose-limiting toxicities.
The company will present preliminary Phase 1b dose escalation study data in combination with palbociclib, in late 2022.
Olema plans to initiate a pivotal Phase 3 monotherapy study in the second/third-line setting in mid-2023.
Price Action: OLMA shares closed at $3.57 on Tuesday.