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Profile Name ERBB2 exon 20 ins
Gene Variant Detail

ERBB2 exon 20 ins (unknown)

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 lung non-small cell 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 lung non-small cell carcinoma predicted - sensitive Trastuzumab + Vinorelbine Case Reports/Case Series Actionable In a clinical study, treatment with the combination of Herceptin (trastuzumab) and Navelbine (vinorelbine) in non-small cell lung cancer patients harboring an ERBB2 exon 20 insertion (n=8) resulted in a partial response in 5 patients and stable disease in 2 patients (PMID: 23610105). 23610105
ERBB2 exon 20 ins lung non-small cell carcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series 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 lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series 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 lung non-small cell carcinoma predicted - sensitive Carboplatin + Paclitaxel + Trastuzumab Case Reports/Case Series Actionable In a clinical study, treatment with the combination of Herceptin (trastuzumab), Paraplatin (carboplatin), and Taxol (paclitaxel) in non-small cell lung cancer patients harboring an ERBB2 exon 20 insertion (n=2) resulted in a partial response in one patient and stable disease in the other patient (PMID: 23610105). 23610105
ERBB2 exon 20 ins lung non-small cell carcinoma predicted - sensitive Docetaxel + Trastuzumab Case Reports/Case Series Actionable In a clinical study, treatment with the combination of Herceptin (trastuzumab) and Taxotere (docetaxel) in a non-small cell lung cancer patient harboring an ERBB2 exon 20 insertion resulted in a partial response (PMID: 23610105). 23610105
ERBB2 exon 20 ins 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 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 non-small cell carcinoma predicted - sensitive Trastuzumab Case Reports/Case Series Actionable In a clinical study, Herceptin (trastuzumab) treatment in a non-small cell lung cancer patient harboring an ERBB2 exon 20 insertion resulted in a partial response (PMID: 23610105). 23610105
ERBB2 exon 20 ins lung non-small cell carcinoma predicted - sensitive Trastuzumab Case Reports/Case Series 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 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
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...
Clinical Trial Phase Therapies Title Recruitment Status
NCT03318939 Phase II Poziotinib Phase 2 Study of Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation Recruiting
NCT03066206 Phase II Poziotinib Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC Recruiting
NCT04172597 Phase II Poziotinib A Study of Poziotinib in Patients With EGFR or HER2 Activating Mutations in Advanced Malignancies Recruiting
NCT04335292 Phase II Cisplatin + Pemetrexed Disodium Carboplatin + Pemetrexed Disodium Osimertinib Osimertinib Then Chemotherapy in EGFR-mutated Lung Cancer With Osimertinib Third-line Rechallenge (OCELOT) Not yet recruiting
NCT04209465 Phase I BDTX-189 A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors. Recruiting
NCT02716116 Phase Ib/II AP32788 A Trial of TAK-788 (AP32788) in Non-small Cell Lung Cancer (NSCLC) Active, not recruiting