Molecular Profile |
Indication/Tumor Type |
Response Type |
Relevant Treatment Approaches |
Therapy Name |
Approval Status |
Evidence Type |
Efficacy Evidence |
References |
ERBB2 mutant
|
invasive bladder transitional cell carcinoma
|
predicted - sensitive |
|
Cisplatin + Gemcitabine + Sorafenib
|
Phase II |
Actionable |
In a Phase II trial, ERBB2 (HER2) mutations were only detected in patients with muscle-invasive urothelial bladder cancer that responded to Nexavar (sorafenib), Platinol (cisplatin) and Gemzar (gemcitabine) combination therapy (J Clin Oncol 35, 2017 (suppl 6S; abstract 345)).
|
detail...
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ERBB2 mutant
|
Her2-receptor positive breast cancer
|
sensitive |
|
Neratinib
|
Phase II |
Actionable |
In a Phase II trial, Nerlynx (neratinib) treatment resulted in complete response in 12.5% (3/24) and partial response in 20.8% (5/24) of ERBB2 (HER2) mutant but not amplified breast cancer patients (Cancer Res 2017;77(4 Suppl):Abstract nr PD2-08).
|
detail...
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ERBB2 mutant
|
non-small cell lung carcinoma
|
predicted - sensitive |
|
Trastuzumab
|
Clinical Study |
Actionable |
In a clinical study, treatment with Herceptin (trastuzumab) in combination with chemotherapy resulted in an objective response rate of 67% (4/6) in non-small cell lung carcinoma patients harboring ERBB2 (HER2) mutations that progressed during previous therapies (PMID: 28167203).
|
28167203
|
ERBB2 mutant
|
non-small cell lung carcinoma
|
sensitive |
|
trastuzumab emtansine
|
Guideline |
Actionable |
Kadcyla (trastuzumab emtansine) is included in guidelines for non-small cell lung cancer patients with ERBB2 (HER2) mutations (NCCN.org).
|
detail...
|
ERBB2 mutant
|
lung adenocarcinoma
|
sensitive |
|
Afatinib
|
Phase II |
Actionable |
In a Phase II trial, treatment with Gilotrif (afatinib) resulted in objective response in 3 lung adenocarcinoma patients harboring ERBB2 (HER2) mutations (PMID: 22325357).
|
22325357
|
ERBB2 mutant
|
urinary bladder cancer
|
no benefit |
|
Neratinib
|
Phase II |
Actionable |
In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, a clinical benefit rate of 18.8% (3/16), and a median progression-free survival of 1.8 months in patients with bladder cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926).
|
29420467
|
ERBB2 mutant
|
ovarian cancer
|
no benefit |
|
Neratinib
|
Phase II |
Actionable |
In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, no clinical benefit, and a median progression-free survival of 2.1 months in patients with ovarian cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926).
|
29420467
|
ERBB2 mutant
|
lung squamous cell carcinoma
|
predicted - sensitive |
|
Afatinib
|
Phase III |
Actionable |
In a Phase III trial (LUX-Lung 8), secondary analysis demonstrated favorable outcomes with Gilotrif (afatinib) treatment compared to Tarceva (erlotinib) in lung squamous cell carcinoma patients with ERBB (HER) family mutations, and ERBB2 (HER2) mutations predicted an OS (HR=0.06, p=0.02) and PFS (HR=0.06, p=0.02) benefit for Gilotrif (afatinib) over Tarceva (erlotinib) treatment (PMID: 29902295; NCT01523587).
|
29902295
|
ERBB2 mutant
|
endometrial cancer
|
no benefit |
|
Neratinib
|
Phase II |
Actionable |
In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, a clinical benefit rate of 28.6% (2/7), and a median progression-free survival of 2.6 months in patients with endometrial cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926).
|
29420467
|
ERBB2 mutant
|
non-small cell lung carcinoma
|
sensitive |
|
Neratinib
|
Phase I |
Actionable |
In a Phase I study, Nerlynx (neratinib) administered with temsirolimus was tolerable and demonstrated antitumor activity in ERBB2-mutant non-small-cell lung cancer (PMID: 24323026).
|
24323026
|
ERBB2 mutant
|
non-small cell lung carcinoma
|
sensitive |
|
Neratinib
|
Phase II |
Actionable |
In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in an objective response rate of 3.8% (1/26), a clinical benefit rate of 42.3% (11/26), and a median progression-free survival of 5.5 months in patients with non-small cell lung cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926).
|
29420467
|
ERBB2 mutant
|
Her2-receptor negative breast cancer
|
sensitive |
|
Neratinib
|
Phase II |
Actionable |
In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in an object response rate of 24% (6/25), a clinical benefit rate of 40% (10/25), and a median progression-free survival of 3.5 months in patients with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926).
|
29420467
|
ERBB2 mutant
|
non-small cell lung carcinoma
|
sensitive |
|
Pyrotinib
|
Phase II |
Actionable |
In a Phase II trial, Pyrotinib treatment in non-small cell lung cancer patients harboring an ERBB2 (HER2) mutation resulted in a partial response in 54.5% (6/11) of patients and stable disease in 27.3% (3/11) of patients, and a PFS of 6.2 months (Journal of Thoracic Oncology, Vol. 12, Issue 1, S359).
|
detail...
|
ERBB2 mutant
|
non-small cell lung carcinoma
|
predicted - sensitive |
|
Afatinib
|
Clinical Study |
Actionable |
In a clinical study, treatment with Gilotrif (afatinib) resulted in an objective response rate of 33% (2/6) in non-small cell lung carcinoma patients harboring ERBB2 (HER2) mutations that progressed during previous therapies (PMID: 28167203).
|
28167203
|
ERBB2 mutant
|
non-small cell lung carcinoma
|
sensitive |
|
AV-412
|
Preclinical |
Actionable |
In a preclinical study, non-small cell lung cancer cells harboring an ERBB2 (HER2) mutation demonstrated sensitivity to AV-412, resulting in decreased phosphorylation of Erbb2, Akt, and Erk (PMID: 19459856).
|
19459856
|
ERBB2 mutant
|
biliary tract cancer
|
predicted - sensitive |
|
Neratinib
|
Phase II |
Actionable |
In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in an objective response rate at 8 weeks of 22.2% (2/9), a clinical benefit rate of 33.3% (3/9), and a median progression-free survival of 2.8 months in patients with biliary tract cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926).
|
29420467
|
ERBB2 mutant
|
gastroesophageal junction adenocarcinoma
|
no benefit |
|
Neratinib
|
Phase II |
Actionable |
In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, a clinical benefit rate of 20% (1/5), and a median progression-free survival of 1.7 months in patients with gastroesophageal cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926).
|
29420467
|
ERBB2 mutant
|
colorectal cancer
|
no benefit |
|
Neratinib
|
Phase II |
Actionable |
In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, a clinical benefit rate of 8.3% (1/12), and a median progression-free survival of 1.8 months in patients with colorectal cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926).
|
29420467
|
ERBB2 mutant
|
cervical cancer
|
predicted - sensitive |
|
Neratinib
|
Phase II |
Actionable |
In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in an objective response rate of 20% (1/5), a clinical benefit rate of 60% (3/5), and a median progression-free survival of 20.1 months in patients with cervical cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926).
|
29420467
|
ERBB2 mutant
|
lung cancer
|
sensitive |
|
Neratinib
|
Phase I |
Actionable |
In a Phase I clinical trial, Nerlynx (neratinib) administered with Torisel (temsirolimus) was tolerable and demonstrated antitumor activity in ERBB2 (HER2)-mutant non-small-cell lung cancer (PMID: 24323026).
|
24323026
|
ERBB2 mutant
|
breast cancer
|
predicted - sensitive |
|
Neratinib
|
Phase II |
Actionable |
In a Phase II trial, Nerlynx (neratinib) demonstrated activity in metastatic breast cancer patients harboring ERBB2 (HER2) mutations, with treatment resulting in a clinical benefit rate of 31% (5/16; 1 complete response, 1 partial response, and 3 patients achieving stable disease for 24 weeks or more) and a median progression-free survival of 16 weeks (PMID: 28679771).
|
28679771
|