PBYI

Neratinib (HKI-272)

Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer and Brain Metastases

Phase 2 (Data)

Exp Date

H1 2021

Amp Volatility Score

N/A

Catalyst Info & Data Links

TITLE: Neratinib (HKI-272) for HER2-positive breast cancer and Brain Metastases 

  • ClinicalTrials.gov (NCT01494662): HKI-272 for HER2-Positive Breast Cancer and Brain Metastases


WHAT IS THE CATALYST EVENT?

  • Phase 2 Data


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?


PRIOR DATA/EVENTS

PRESS RELEASE

MECHANISM OF ACTION

  • Neratinib is an intracellular kinase inhibitor that irreversibly binds to epidermal growth factor receptor (EGFR), HER2, and HER4. In vitro, neratinib reduces EGFR and HER2 autophosphorylation, downstream MAPK and AKT signaling pathways, and showed antitumor activity in EGFR and/or HER2 expressing carcinoma cell lines. Neratinib human metabolites M3, M6, M7 and M11 inhibited the activity of EGFR, HER2, and HER4 in vitro. In vivo, oral administration of neratinib inhibited tumor growth in mouse xenograft models with tumor cell lines expressing HER2 and EGFR.

MARKET

  • Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

Updated by HC

PBYI, HER2-positive breast cancer and brain Metastases, brain tumor cancer, NERLYNX, Neratinib (HKI-272)

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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