secwatch.observer — SEC 8-K summary
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Issuer:     Olema Pharmaceuticals, Inc. (OLMA)
CIK:        0001750284
Form:       8-K
Filed at:   2025-10-20T23:59:59+00:00
Accession:  0001193125-25-243765
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Olema reports palazestrant + ribociclib Phase 1b/2 mPFS of 15.5 months in ER+/HER2- MBC
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- As of July 8, 2025, 72 patients enrolled across 90 mg and 120 mg palazestrant dose cohorts with ribociclib 600 mg.
- Median PFS for 120 mg cohort (56 patients) was 15.5 months for all; 12.2 months in prior CDK4/6i patients.
- In prior CDK4/6i patients, mPFS was 9.2 months (ESR1 wild-type) and 13.8 months (ESR1 mutant tumors).
- Combination well tolerated, no new safety signals, no drug-drug interactions, consistent with known profiles.
- Data support ongoing Phase 3 OPERA-02 trial evaluating palazestrant + ribociclib in frontline MBC.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1750284/000119312525243765/0001193125-25-243765-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1750284/000119312525243765/olma-20251018.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-243765

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer