secwatch.observer — SEC 8-K summary
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Issuer:     PUMA BIOTECHNOLOGY, INC. (PBYI)
CIK:        0001401667
Form:       8-K
Filed at:   2022-12-08T23:59:59+00:00
Accession:  0001437749-22-028687
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Puma presents Phase II TBCRC-022 data: neratinib+T-DM1 achieves CNS ORR 28-33% in HER2+ BCBM
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- CNS objective response rate by RANO-BM: 33.3% (cohort 4A), 29.4% (4B), 28.6% (4C).
- Response + stable disease ≥6 months: 50% (4A), 35.3% (4B), 33.3% (4C).
- Intracranial activity observed including prior T-DM1 exposure, suggesting reversal of resistance.
- Most common adverse event: diarrhea (grade 2 32%, grade 3 23%); prophylaxis required.
- Data from prospective, multicenter Phase II study; presented at San Antonio Breast Cancer Symposium.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1401667/000143774922028687/0001437749-22-028687-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1401667/000143774922028687/pbyi20221206_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-22-028687

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