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Association details:
| Biomarker: | ER positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | palazestrant (OP-1250) (Estrogen receptor antagonist, Selective estrogen receptor degrader) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Olema Oncology Receives FDA Fast Track Designation for OP-1250 for the Treatment of ER+ / HER2- Metastatic Breast Cancer
Published date:
07/21/2022
Excerpt:
Olema Pharmaceuticals...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to OP-1250, the Company's novel, oral complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD), for the treatment of ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer...OP-1250 is currently being evaluated as a single agent in an ongoing Phase 1/2 clinical trial and in Phase 1b combination with palbociclib in patients with recurrent, locally advanced, or metastatic ER+/HER2- breast cancer.
Source:
Title:
Phase 1b results from OP-1250-001, a dose escalation and dose expansion study of OP-1250, an oral CERAN, in subjects with advanced and/or metastatic estrogen receptor (ER)-positive, HER2-negative breast cancer (NCT04505826)
Published date:
10/12/2022
Excerpt:
OP-1250 is being developed for ER+, HER2- metastatic breast cancer (MBC) patients (pts). We previously reported Phase 1a (dose escalation) results, here we present data from the Phase 1b expansion portion of the clinical trial….Across Phase 1b, among pts eligible for at least one post-baseline scan (n=24), 1 confirmed PR (cPR) was observed at 60 mg and 1 uPR was observed at 120 mg....OP-1250 was well tolerated and showed promising safety and efficacy in Phase 1b pts treated at 60 mg and 120 mg daily.
