other material
confidence high
sentiment positive
materiality 0.70
Puma presents Phase II TBCRC-022 data: neratinib+T-DM1 achieves CNS ORR 28-33% in HER2+ BCBM
PUMA BIOTECHNOLOGY, INC.
- 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.