---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-22-028687"
form_type: "8-K"
ticker: "PBYI"
cik: "0001401667"
company_name: "PUMA BIOTECHNOLOGY, INC."
filed_at: "2022-12-08T23:59:59+00:00"
generated_at: "2026-06-21T07:25:18.430371+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Puma presents Phase II TBCRC-022 data: neratinib+T-DM1 achieves CNS ORR 28-33% in HER2+ BCBM

## Summary
- 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.

## SEC filing metadata
- accession: 0001437749-22-028687
- form_type: 8-K
- ticker: PBYI
- cik: 0001401667
- company_name: PUMA BIOTECHNOLOGY, INC.
- filed_at: 2022-12-08T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1401667/000143774922028687/0001437749-22-028687-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1401667/000143774922028687/pbyi20221206_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-22-028687
- JSON: https://secwatch.observer/filing/0001437749-22-028687.json
- Plain text: https://secwatch.observer/filing/0001437749-22-028687.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.