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Profile Name ERBB2 G778_P780dup
Gene Variant Detail

ERBB2 G778_P780dup (gain of function)

Relevant Treatment Approaches HER inhibitor (Pan) HER2 Inhibitor

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 G778_P780dup breast cancer sensitive HER inhibitor (Pan) Ado-trastuzumab emtansine + Poziotinib Preclinical - Cell culture Actionable In a preclinical study, addition of Poziotinib (HM781-36B) enhanced growth inhibition by Kadcyla (ado-trastuzumab emtansine) treatment in breast cancer cells expressing ERBB2 (HER2) G778_P780dup in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup Advanced Solid Tumor resistant HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) demonstrated decreased response to Gilotrif (afatinib) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 G778_P780dup Advanced Solid Tumor resistant HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup were resistant to Gilotrif (afatinib) in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup Advanced Solid Tumor resistant Nazartinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup were resistant to Nazartinib (EGF816) in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup lung non-small cell carcinoma predicted - sensitive HER2 Inhibitor Pyrotinib Case Reports/Case Series Actionable In a Phase II trial, Pyrotinib treatment resulted in an objective response rate of 60% (3/5) in non-small cell lung cancer patients harboring ERBB2 (HER2) G778_P780dup (also reported as P780_Y781insGSP) who had received prior platinum-based chemotherapy (PMID: 32614698; NCT02834936). 32614698
ERBB2 G778_P780dup lung non-small cell carcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Clinical Study Actionable In a retrospective analysis, Gilotrif (afatinib) treatment resulted in an objective response rate of 25% (1/4) in non-small cell lung cancer patients harboring ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) (PMID: 30527195). 30527195
ERBB2 G778_P780dup lung cancer sensitive HER inhibitor (Pan) Afatinib Preclinical Actionable In a preclinical study, Gilotrif (afatinib) inhibited Erbb2 (Her2) phosphorylation and downstream signaling in bronchial epithelial cells expressing ERBB2 (HER2) G778_P780dup (also referred to as P780_Y781insGSP) in culture (PMID: 26545934). 26545934
ERBB2 G778_P780dup lung adenocarcinoma sensitive HER inhibitor (Pan) Dacomitinib Case Reports/Case Series Actionable In a Phase II trial, two lung adenocarcinoma patients harboring ERBB2 (HER2) G778_780dup (reported as P780_Y781insGSP) demonstrated partial response to treatment with Vizimpro (dacomitinib) (PMID: 25899785; NCT00818441). 25899785
ERBB2 G778_P780dup Advanced Solid Tumor sensitive HER2 Inhibitor Pyrotinib Preclinical - Cell culture Actionable In a preclinical study, Pyrotinib inhibited survival of transformed cells expressing ERBB2 (HER2) G778_P780dup in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup breast cancer sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial, Nerlynx (neratinib) treatment resulted in a clinical benefit rate of 31% (5/16) in metastatic breast cancer patients harboring ERBB2 (HER2) mutations, with 1 complete response (referred to as V777_G778insGSP) and 1 stable disease for more than 24 weeks (referred to as P780_Y781insGSP) in 3 patients harboring ERBB2 G778_P780dup (PMID: 28679771; NCT01670877). 28679771
ERBB2 G778_P780dup breast cancer sensitive HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 (HER2) P780_Y781insGSP reverted to normal morphology in culture upon Nerlynx (neratinib) treatment (PMID: 23220880). 23220880
ERBB2 G778_P780dup breast cancer resistant Lapatinib Preclinical - Cell culture Actionable In a preclinical study, breast epithelial cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) were resistant to Tykerb (lapatinib) treatment in cell culture (PMID: 31980423). 31980423
ERBB2 G778_P780dup breast cancer resistant Lapatinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 P780_Y781insGSP demonstrated resistance when treated with Tykerb (lapatinib) (PMID: 23220880). 23220880
ERBB2 G778_P780dup breast cancer sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited viability of breast cancer cells expressing ERBB2 (HER2) G778_P780dup in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup breast cancer predicted - sensitive Lapatinib + Perifosine Preclinical - Cell culture Actionable In a preclinical study, addition of Perifosine restored sensitivity to Tykerb (lapatinib) in breast epithelial cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP in culture (PMID: 31980423). 31980423
ERBB2 G778_P780dup Advanced Solid Tumor resistant AZ5104 Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) were resistant to AZ5104 in culture (PMID: 30527195). 30527195
ERBB2 G778_P780dup breast cancer resistant Trastuzumab Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 P780_Y781insGSP demonstrated resistance when treated with Herceptin (trastuzumab) (PMID: 23220880). 23220880
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER2 Inhibitor Pyrotinib Case Reports/Case Series Actionable In a clinical case study, Pyrotinib treatment resulted in an ongoing partial response of six months in a lung adenocarcinoma patient harboring ERBB2 (HER2) G778_P780dup (also reported as P780_Y781insGSP) who had progressed on prior therapies (PMID: 32036069). 32036069
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER2 Inhibitor Pyrotinib Case Reports/Case Series Actionable In a clinical case study, Pyrotinib treatment resulted in three months of stable disease in a lung adenocarcinoma patient harboring ERBB2 (HER2) G778_P780dup (also reported as V777_G778insGSP) who had progressed on several prior lines of therapy (PMID: 32036069). 32036069
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER2 Inhibitor Pyrotinib Case Reports/Case Series Actionable In a clinical case study, Pyrotinib treatment resulted in an ongoing partial response of eight months in a lung adenocarcinoma patient harboring ERBB2 (HER2) G778_P780dup (also reported as V777_G778insGSP) with prior disease progression with Gilotrif (afatinib) (PMID: 32036069). 32036069
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib + Cisplatin + Pemetrexed Disodium Case Reports/Case Series Actionable In a clinical case study, the combination of Gilotrif (afatinib), Platinol (cisplatin), and Alimta (Pemetrexed Disodium) followed by the combination of Gilotrif (afatinib) and Alimta (Pemetrexed Disodium) resulted in an ongoing partial response over 19 months in a patient with lung adenocarcinoma harboring ERBB2 (HER2) G778_P780dup (also reported as P780_Y781insGSP) (PMID: 32036069). 32036069
ERBB2 G778_P780dup Her2-receptor positive breast cancer predicted - resistant Lapatinib Case Reports/Case Series Actionable In a clinical case study, ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) was identified in a patient with ERBB2 (HER2)-positive breast cancer at the time of disease progression while on Tykerb (lapatinib) treatment (PMID: 31980423). 31980423
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a clinical case study, a patient with metastatic lung adenocarcinoma harboring ERBB2 (HER2) G778_P780dup (also referred to as V777_G778insGSP) demonstrated tumor shrinkage and clinical response for 7 months following treatment with Gilotrif (afatinib) (PMID: 28363995). 28363995
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a clinical study, a lung adenocarcinoma patient harboring ERBB2 (HER2) G778_P780dup (also referred to as V747_G748insGSP and G748_P750dup), demonstrated a 13% regression of target lesions and stable disease for 11 months following treatment with pulse Gilotrif (afatinib) (PMID: 26964772). 26964772
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Clinical Study - Cohort Actionable In a retrospective study, Gilotrif (afatinib) treatment resulted in an objective response rate (ORR) of 15.6% (5/32) and a disease control rate of 68.8% (22/32) in patients with lung adenocarcinoma harboring ERBB2 (HER2) mutations, patients harboring G776delinsVC (n=5) or G778_P780dup (n=5) achieved longer median progression-free survival (7.6 mo) than those with Y772_A775dup (n=14, 1.2 mo) or missense mutations (n=8, 3.6 mo), with an ORR of 40% (4/10) and a DCR of 100% (10/10) (PMID: 32162827). 32162827
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a clinical case study, three lung adenocarcinoma patients harboring ERBB2 (HER2) G778_P780dup (also reported as V777_G778insGSP) demonstrated stable disease lasting between five and eight months following Gilotrif (afatinib) treatment (PMID: 32036069). 32036069
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a clinical case study, a patient with metastatic lung adenocarcinoma harboring ERBB2 (HER2) G778_P780dup (also reported as P780_Y781insGSP) demonstrated a 51% reduction in primary tumor size after one month with a partial response lasting eight months following treatment with Gilotrif (afatinib) (PMID: 32036069). 32036069
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a clinical case study, a lung adenocarcinoma patient harboring ERBB2 (HER2) G778_P780dup (also reported as P780_Y781insGSP) demonstrated a partial response lasting nine months following Gilotrif (afatinib) treatment (PMID: 32036069). 32036069
ERBB2 G778_P780dup Advanced Solid Tumor resistant Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) were resistant to Tarceva (erlotinib) in culture (PMID: 30527195). 30527195
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive Ado-trastuzumab emtansine Case Reports/Case Series Actionable In a Phase II trial, treatment with Kadcyla (trastuzumab emtansine) resulted in best overall responses of partial response in 44% (8/18) and stable disease in 39% (7/18), and median progression-free survival of 5 months in patients with lung adenocarcinoma harboring ERBB2 (HER2) activating mutations, and a subset of patients specifically harboring ERBB2 (HER2) G778_P780dup (also referred to as P780_Y781insGSP) had a 33% (1/3) partial response rate (PMID: 29989854; NCT02675829). 29989854
ERBB2 G778_P780dup Her2-receptor negative breast cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in partial response with a progression-free survival of 3.5 months in one patient, and stable disease with a progression-free survival of 20.0 months in another patient with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) G778_P780dup (PMID: 29420467; NCT01953926). 29420467
ERBB2 G778_P780dup Advanced Solid Tumor conflicting HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup were resistant to Nerlynx (neratinib) in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup Advanced Solid Tumor conflicting HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of transformed cells expressing ERBB2 (HER2) G778_P780dup (also referred to as P780_Y781insGSP) in culture (PMID: 28363995). 28363995
ERBB2 G778_P780dup Advanced Solid Tumor conflicting HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) P780_Y781insGSP demonstrated decreased response to Nerlynx (neratinib) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 G778_P780dup lung non-small cell carcinoma no benefit HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival over 17 months in 2 patients with non-small cell lung cancer harboring ERBB2 (HER2) G778_P780dup (PMID: 29420467; NCT01953926). 29420467
ERBB2 G778_P780dup Advanced Solid Tumor resistant HER2 Inhibitor Ibrutinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup were resistant to Imbruvica (ibrutinib) in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Poziotinib Case Reports/Case Series Actionable In a clinical case study, Poziotinib (HM781-36B) treatment resulted in stable disease lasting nine months in a metastatic lung adenocarcinoma patient harboring ERBB2 (HER2) G778_P780dup (also reported as P780_Y781insGSP) with prior disease progression following an initial partial response to Gilotrif (afatinib) (PMID: 32036069). 32036069
ERBB2 G778_P780dup lung non-small cell carcinoma predicted - sensitive HER inhibitor (Pan) Poziotinib Phase II Actionable In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in a confirmed objective response rate of 42% (5/12) in patients with non-small cell lung cancer harboring ERBB2 (HER2) Y772_A775dup (n=9) or ERBB2 (HER2) G778_P780dup (n=3), with a median progression-free survival of 5.6 months (PMID: 31588020; NCT03066206). 31588020
ERBB2 G778_P780dup Advanced Solid Tumor sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited growth of a transformed cell line expressing ERBB2 (HER2) G778_P780dup (reported P780insGSP) in culture (PMID: 29686424). 29686424
ERBB2 G778_P780dup Advanced Solid Tumor sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) P780_Y781insGSP in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup Advanced Solid Tumor resistant HER2 Inhibitor Sapitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup were resistant to Sapitinib (AZD8931) in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup Advanced Solid Tumor resistant Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P80dup were resistant to Tykerb (lapatinib) in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup Advanced Solid Tumor resistant Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) were resistant to Tykerb (lapatinib) in culture (PMID: 30527195). 30527195
ERBB2 G778_P780dup Advanced Solid Tumor decreased response HER2 Inhibitor Tucatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) demonstrated decreased response to Tukysa (tucatinib) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 G778_P780dup Advanced Solid Tumor decreased response Osimertinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) demonstrated decreased response to Tagrisso (osimertinib) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 G778_P780dup Advanced Solid Tumor decreased response Osimertinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) P780_Y781insGSP were resistant to Tagrisso (osimertinib) in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup Advanced Solid Tumor conflicting HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup were resistant to Vizimpro (dacomitinib) in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup Advanced Solid Tumor conflicting HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited growth of transformed cells expressing ERBB2 (HER2) G778_P780dup (also referred to as P780_Y781insGSP) in culture (PMID: 28363995). 28363995
ERBB2 G778_P780dup lung cancer no benefit Gefitinib Preclinical Actionable In a preclinical study, bronchial epithelial cells expressing ERBB2 (HER2) G778_P780dup (also referred to as P780_Y781insGSP) did not demonstrate sensitivity to Iressa (gefitinib) in culture (PMID: 26545934). 26545934
ERBB2 G778_P780dup Advanced Solid Tumor sensitive HER2 Inhibitor Tarloxotinib Preclinical - Cell culture Actionable In a preclinical study, Tarloxotinib (TRLX) inhibited survival of transformed cells expressing ERBB2 (HER2) G778_P780dup in culture (PMID: 31588020). 31588020
Clinical Trial Phase Therapies Title Recruitment Status
NCT02675829 Phase II Ado-trastuzumab emtansine Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers Active, not recruiting
NCT02673398 Phase II Neratinib Neratinib in Treating Older Patients With Locally Advanced or Metastatic HER2-Positive Breast Cancer Active, not recruiting