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
|