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|Therapy Name||Ado-trastuzumab emtansine + Neratinib|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Ado-trastuzumab emtansine||Kadcyla||T-DM1|trastuzumab emtansine||HER2 (ERBB2) Antibody 50||Kadcyla (ado-trastuzumab emtansine) is an antibody drug conjugate combined of the ERBB2 (HER2) monoclonal antibody, trastuzumab, and an anti-tubulin agent, DM1, which results in tumor cell cytotoxicity (PMID: 24887180). Kadcyla (ado-trastuzumab emtansine) is FDA approved for metastatic ERBB2 (HER2)-positive (overexpression or gene amplification) breast cancer patients who have previously received trastuzumab and/or taxane, and for the adjuvant treatment of patients with ERBB2 (HER2)-positive early breast cancer who have residual invasive disease after taxane and trastuzumab-based treatment (FDA.gov).|
|Neratinib||Nerlynx||HKI-272|PB272||HER2 Inhibitor 26||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 use in patients with early stage ERBB2 (HER2)-positive breast cancer following Herceptin (trastuzumab)-based therapy, and in combination with Xeloda (capecitabine) in patients with advanced/metastatic ERBB2 (HER2)-positive breast cancer who have received two or more anti-ERBB2 (HER2) regimens (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|ERBB2 amp||Her2-receptor positive breast cancer||predicted - sensitive||Ado-trastuzumab emtansine + Neratinib||Case Reports/Case Series||Actionable||In a Phase II trial, a patient with ERBB2 (HER2) amplified breast cancer who had progressed on Kadcyla (ado-trastuzumab emtansine) was switched to combination therapy with Kadcyla (ado-trastuzumab emtansine) and Nerlynx (neratinib), which led to a partial response (38%) after 6 weeks, and remained on combination treatment for an additional 12 weeks at which intracranial progression was observed (PMID: 32213539; NCT01494662).||32213539|
|ERBB2 S310F ERBB2 amp||lung cancer||predicted - sensitive||Ado-trastuzumab emtansine + Neratinib||Preclinical - Pdx||Actionable||In a preclinical study, combination treatment with Kadcyla (ado-trastuzumab emtansine) and Nerlynx (neratinib) in a patient-derived xenograft (PDX) model of lung cancer harboring ERBB2 (HER2) amplification and ERBB2 (HER2) S310F resulted in greater inhibition of tumor growth than either agent alone (PMID: 32213539).||32213539|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT02236000||Phase Ib/II||Ado-trastuzumab emtansine + Neratinib||A Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer||Active, not recruiting||USA||0|