Oct 26, 2022 8:01 am | 1 minute read
- Olema Pharmaceuticals Inc OLMA announced preliminary clinical results from a phase 1/2 study of OP-1250, a total estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD) for metastatic breast cancer.
- In 68 patients on once-daily oral doses of 60 mg and 120 mg, OP-1250 was well tolerated with attractive pharmacokinetics (PK) and drug exposure levels approximately 20-fold greater than fulvestrant at the 120 mg dose.
- Related: Olema denies data leaks and shares first data for leading program in breast cancer patients.
- OP-1250 demonstrated potent anti-tumor activity and sustained benefit, with 41% of patients seeing a reduction in target tumor lesions and six partial responses (4 confirmed and 2 unconfirmed) from 57 patients with evaluable efficacy.
- Treatment with OP-1250 was well tolerated at both the 60 mg and 120 mg doses with no dose-limiting toxicity.
- The company will present preliminary data from the phase 1b dose escalation study in combination with palbociclib in late 2022.
- Olema plans to initiate a pivotal phase 3 monotherapy study in second-/third-line therapy in mid-2023.
- Price promotion: OLMA shares closed at $3.57 on Tuesday.
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