secwatch.observer — SEC 8-K summary
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Issuer:     Olema Pharmaceuticals, Inc. (OLMA)
CIK:        0001750284
Form:       8-K
Filed at:   2023-10-23T23:59:59+00:00
Accession:  0001558370-23-016589
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Olema reports Phase 2 palazestrant results: median PFS 4.6 mo in all patients; 7.2 mo in 2nd/3rd-line subset
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- Palazestrant (OP-1250) median PFS of 4.6 months (CBR 40%) in 86 heavily pretreated metastatic ER+/HER2- breast cancer patients.
- In ESR1-mutant patients (48% of ctDNA-assessed), median PFS 5.6 months, CBR 52%; in 2nd/3rd-line subset PFS 7.3 mo, CBR 59%.
- Safety: well-tolerated at 120 mg; Grade 4 neutropenia in 6 patients (all prior CDK4/6i), managed with dose reduction/discontinuation.
- Company plans to initiate OPERA-01, a Phase 3 pivotal monotherapy trial in 2nd/3rd-line metastatic breast cancer.
- Results presented at ESMO 2023; Olema hosted investor call on Oct 23, 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1750284/000155837023016589/0001558370-23-016589-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1750284/000155837023016589/olma-20231022x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-23-016589

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