Therapy Detail

Therapy Name Neratinib + Trastuzumab
Synonym
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Neratinib Nerlynx HKI-272|PB272 HER2 Inhibitor 22 Nerlynx (neratinib) inhibits the ERBB2 (HER2) receptor as well as EGFR, resulting in decreased proliferation of HER2 and EGFR expressing tumor cells (PMID: 15173008). Nerlynx (neratinib) is FDA approved for breast cancer patients with ERBB2 (HER2) overexpression and/or amplification (FDA.gov).
Trastuzumab Herceptin Anti HER2 HER2 (ERBB2) Antibody 29 Herceptin (trastuzumab) is a monoclonal antibody, which binds ERBB2 (HER2) to induce tumor cellular cytotoxicity (PMID: 17611206). Herceptin (trastuzumab) is FDA approved for HER2-overexpressing breast cancer, gastric adenocarcinoma, and gastroesophageal junction adenocarcinoma (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 S310Y colorectal cancer sensitive Neratinib + Trastuzumab Preclinical Actionable In a preclinical study, Herceptin (trastuzumab) and Nerlynx (neratinib) combination treatment resulted in tumor regression in xenograft models of patient derived colorectal cancer cells harboring ERBB2 (HER2) S310Y (PMID: 26243863). 26243863
ERBB2 V777L colorectal cancer sensitive Neratinib + Trastuzumab Preclinical - Cell line xenograft Actionable In a preclinical study, Herceptin (trastuzumab) and Nerlynx (neratinib) combination treatment inhibited growth of colorectal cancer cells over expressing ERBB2 (HER2) V777L in culture and suppressed tumor growth in cell line xenograft models (PMID: 26243863). 26243863
ERBB2 amp ERBB2 L866M colorectal cancer sensitive Neratinib + Trastuzumab Preclinical Actionable In a preclinical study, Herceptin (trastuzumab) and Nerlynx (neratinib) combination treatment resulted in sustained tumor regression in xenograft models of patient derived colorectal cancer cells harboring ERBB2 (HER2) L866M and ERBB2 (HER2) amplification (PMID: 26243863). 26243863
KRAS G12D colorectal cancer resistant Neratinib + Trastuzumab Preclinical Actionable In a preclinical study, Herceptin (trastuzumab) and Nerlynx (neratinib) combination treatment resulted in continued tumor growth in xenograft models of patient derived colorectal cancer cells harboring KRAS G12D (PMID: 26243863). 26243863
Clinical Trial Phase Therapies Title Recruitment Status
NCT03457896 Phase II Cetuximab + Neratinib Neratinib + Trastuzumab Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status Recruiting
NCT03094052 Phase II Neratinib Loperamide Crofelemer Neratinib + Trastuzumab Diarrhea Prophylaxis in Patients With HER2+ Breast Cancer Treated With Trastuzumab and Neratinib, Followed by Neratinib Monotherapy Recruiting