Molecular Profile Detail

Profile Name ERBB2 exon 20 ins
Gene Variant Detail

ERBB2 exon 20 ins (gain of function - predicted)

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 exon 20 ins non-small cell lung carcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Clinical Study Actionable In a clinical study, targeted therapy with Gilotrif (afatinib) or Herceptin (trastuzumab) resulted in an objective response rate of 44% (4/9) in non-small cell lung carcinoma patients harboring ERBB2 (HER2) mutations that progressed during previous therapies, all four responders harbored ERBB2 (HER2) exon 20 insertions (PMID: 28167203). 28167203
ERBB2 exon 20 ins non-small cell lung carcinoma no benefit HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease in 10 and progressive disease in 5 of the 15 patients with non-small cell lung cancer harboring ERBB2 (HER2) exon 20 insertion mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 exon 20 ins Advanced Solid Tumor sensitive HER2 Inhibitor AP32788 Preclinical - Pdx & cell culture Actionable In a preclinical study, AP32788 inhibited growth of transformed cell lines over expressing ERBB2 (HER2) exon 20 insertions in culture, and induced tumor regression in PDX models (AACR, Cancer Res: April 2016; Volume 57, Abstract #2644). detail...
ERBB2 exon 20 ins lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Clinical Study Actionable In a clinical study, treatment with pulse Gilotrif (afatinib) resulted in an objective response rate of 33.3% (1/3) in lung adenocarcinoma patients with ERBB2 (HER2) exon 20 insertion mutations (PMID: 26964772). 26964772
ERBB2 exon 20 ins non-small cell lung carcinoma predicted - sensitive Trastuzumab Clinical Study Actionable In a clinical study, targeted therapy with Gilotrif (afatinib) or Herceptin (trastuzumab) resulted in an objective response rate of 44% (4/9) in non-small cell lung carcinoma patients harboring ERBB2 (HER2) mutations that progressed during previous therapies, all four responders harbored ERBB2 (HER2) exon 20 insertions (PMID: 28167203). 28167203
ERBB2 exon 20 ins Her2-receptor negative breast cancer predicted - sensitive HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in complete response in 1, partial response in 1, and stable disease in 3 of the 5 patients with Erbb2 (Her2)-receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) exon 20 insertion mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 exon 20 ins lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Dacomitinib Phase II Actionable In a Phase II trial, Vizimpro (dacomitinib) treatment resulted in an overall response rate of 25% (3/26) in patients with lung adenocarcinoma harboring ERBB2 (HER2) exon 20 mutations, including exon 20 insertions, indels, and missense mutations (23, 2, 1, respectively) (PMID: 25899785; NCT00818441). 25899785
Clinical Trial Phase Therapies Title Recruitment Status
NCT03318939 Phase II Poziotinib Phase 2 Study of Poziotinib in Patients With NSCLC With EGFR or HER2 Exon 20 Insertion Mutation Recruiting
NCT02716116 Phase Ib/II AP32788 A Trial of AP32788 in Non-Small Cell Lung Cancer Recruiting