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Therapy Name Dacomitinib
Synonyms
Therapy Description

Vizimpro (dacomitinib) is a second-generation EGFR inhibitor and pan-HER inhibitor that inhibits HER2 and multiple EGFR subtypes including EGFR T790M, resulting in decreased proliferation and increased apoptosis in EGFR-expressing and HER2-expressing tumor cells (PMID: 22761403, PMID: 18606718). Vizimpro (dacomitinib) is FDA approved for use in patients with metastatic non-small cell lung cancer with EGFR exon 19 deletion or L858R mutation as first-line treatment (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Dacomitinib Vizimpro PF-00299804|PF299804 EGFR Inhibitor 2nd gen 3 HER inhibitor (Pan) 5 Vizimpro (dacomitinib) is a second-generation EGFR inhibitor and pan-HER inhibitor that inhibits HER2 and multiple EGFR subtypes including EGFR T790M, resulting in decreased proliferation and increased apoptosis in EGFR-expressing and HER2-expressing tumor cells (PMID: 22761403, PMID: 18606718). Vizimpro (dacomitinib) is FDA approved for use in patients with metastatic non-small cell lung cancer with EGFR exon 19 deletion or L858R mutation as first-line treatment (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 M774delinsWLV ERBB2 C805S Advanced Solid Tumor resistant Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, acquisition of ERBB2 (HER2) C805S in transformed cells expressing ERBB2 (HER2) M774delinsWLV conferred resistance to Vizimpro (dacomitinib) in culture (PMID: 28363995). 28363995
ERBB2 D769N Advanced Solid Tumor sensitive Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited survival of transformed cells expressing ERBB2 (HER2) D769N in culture (PMID: 31588020). 31588020
ERBB2 Y772_A775dup Advanced Solid Tumor resistant Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup were resistant to Vizimpro (dacomitinib) in culture (PMID: 31588020). 31588020
ERBB2 Y772_A775dup Advanced Solid Tumor resistant Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) demonstrated decreased response to Vizimpro (dacomitinib) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 amp gastrointestinal system cancer sensitive Dacomitinib Preclinical Actionable In a preclinical study, Vizimpro (dacomitinib) demonstrated significant growth-inhibitory effects in HER2- amplified gastric cancer cells (PMID: 18606718). 18606718
ERBB2 G776delinsVC lung non-small cell carcinoma no benefit Dacomitinib Clinical Study Actionable In a retrospective analysis, Vizimpro (dacomitinib) treatment resulted in an objective response rate of 0% (0/2) in non-small cell lung cancer patients harboring ERBB2 (HER2) G776delinsVC (PMID: 30527195). 30527195
ERBB2 G778_S779insCPG Advanced Solid Tumor sensitive Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited growth of transformed cells expressing ERBB2 (HER2) G778_S779insCPG in culture (PMID: 28363995). 28363995
ERBB2 exon 20 ins lung adenocarcinoma predicted - sensitive 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 D769Y Advanced Solid Tumor sensitive Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited survival of transformed cells expressing ERBB2 (HER2) D769Y in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVC Advanced Solid Tumor conflicting Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited growth of transformed cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC Advanced Solid Tumor conflicting Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC were resistant to Vizimpro (dacomitinib) in culture (PMID: 31588020). 31588020
ERBB2 V777L Advanced Solid Tumor sensitive Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited survival of transformed cells expressing ERBB2 (HER2) V777L in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVV Advanced Solid Tumor resistant Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVV were resistant to Vizimpro (dacomitinib) in culture (PMID: 31588020). 31588020
ERBB2 M774delinsWLV Advanced Solid Tumor sensitive Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited growth of transformed cells expressing ERBB2 (HER2) M774delinsWLV in culture (PMID: 28363995). 28363995
ERBB2 G776delinsVC ERBB2 C805S Advanced Solid Tumor resistant Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC and an acquired ERBB2 (HER2) C805S were resistant to Vizimpro (dacomitinib) in culture (PMID: 30527195). 30527195
ERBB2 G778_P780dup lung adenocarcinoma sensitive 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 L869R Advanced Solid Tumor sensitive Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited survival of transformed cells expressing ERBB2 (HER2) L869R in culture (PMID: 31588020). 31588020
ERBB2 L786V Advanced Solid Tumor sensitive Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited survival of transformed cells expressing ERBB2 (HER2) L786V in culture (PMID: 31588020). 31588020
ERBB2 amp lung adenocarcinoma no benefit Dacomitinib Case Reports/Case Series Actionable In a Phase II trial, Vizimpro (dacomitinib) treatment resulted in an overall response rate of 0% (0/4) in patients with lung adenocarcinoma harboring ERBB2 (HER2) amplification (PMID: 25899785; NCT00818441). 25899785
ERBB2 L755S Advanced Solid Tumor sensitive Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited survival of transformed cells expressing ERBB2 (HER2) L755S in culture (PMID: 31588020). 31588020
ERBB2 V842I Advanced Solid Tumor sensitive Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited survival of transformed cells expressing ERBB2 (HER2) V842I in culture (PMID: 31588020). 31588020
ERBB2 over exp stomach cancer sensitive Dacomitinib Phase II Actionable In a Phase II trial, Vizimpro (dacomitinib) resulted in a 7.4% (2/27) response rate and 40.7% (11/27) disease control rate when treating advanced gastric cancer patients with ERBB2 (HER2) over expression (J Clin Oncol 30, 2012 (suppl 4; abstr 54)). detail...
ERBB2 over exp stomach cancer sensitive Dacomitinib Preclinical Actionable In a preclinical study, ERBB2 (HER2) over expressing gastric cancer cells were sensitive to Vizimpro (dacomitinib), resulting in inhibition of ERBB2 (HER2)/ERBB3 (HER3) heterodimers (PMID: 22135232). 22135232
ERBB2 Y772_A775dup ERBB2 C805S Advanced Solid Tumor resistant Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells co-expressing ERBB2 (HER2) C805S and ERBB2 (HER2) Y772_A775dup (also referred to as A775_G776insYVMA) demonstrated resistance to Vizimpro (dacomitinib) in culture (PMID: 28363995). 28363995
ERBB2 G778_P780dup Advanced Solid Tumor conflicting 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 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 Y772_A775dup lung non-small cell carcinoma no benefit Dacomitinib Clinical Study Actionable In a retrospective analysis, Vizimpro (dacomitinib) treatment resulted in an objective response rate of 0% (0/13) in non-small cell lung cancer patients harboring ERBB2 (HER2) Y772_A775dup (reported as (A775_G776insYVMA) (PMID: 30527195). 30527195
ERBB2 D769H Advanced Solid Tumor sensitive Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited survival of transformed cells expressing ERBB2 (HER2) D769H in culture (PMID: 31588020). 31588020
ERBB2 amp breast cancer sensitive Dacomitinib Preclinical Actionable In a preclinical study, Vizimpro (dacomitinib) was more effective in preventing proliferation in ERBB2 (HER2) amplified breast cancer cells than in wild-type ERBB2 (HER2) breast cancer cells (PMID: 22761403). 22761403
ERBB2 G778_S779insLPS Advanced Solid Tumor sensitive Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited survival of transformed cells expressing ERBB2 (HER2) G778_S779insLPS in culture (PMID: 31588020). 31588020
ERBB2 L755P Advanced Solid Tumor resistant Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L755P were resistant to Vizimpro (dacomitinib) in culture (PMID: 31588020). 31588020
ERBB2 V773M Advanced Solid Tumor sensitive Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited survival of transformed cells expressing ERBB2 (HER2) V773M in culture (PMID: 31588020). 31588020
ERBB2 M774delinsWLV lung adenocarcinoma sensitive Dacomitinib Case Reports/Case Series Actionable In a Phase II trial, a lung adenocarcinoma patient harboring ERBB2 (HER2) M774delinsWLV demonstrated a partial response to treatment with Vizimpro (dacomitinib) (PMID: 25899785; NCT00818441). 25899785
ERBB2 G776delinsLC Advanced Solid Tumor resistant Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsLC were resistant to Vizimpro (dacomitinib) in culture (PMID: 31588020). 31588020

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Clinical Trial Phase Therapies Title Recruitment Status
NCT01858389 Phase II Dacomitinib A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer Completed
NCT01112527 Phase II Dacomitinib PF-00299804 in Adult Patients With Relapsed/Recurrent Glioblastoma Completed
NCT01465802 Phase II Dacomitinib Alclometasone Doxycycline Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO Completed
NCT03755102 Phase I Dacomitinib A Study of Dacomitinib in Patients With Metastatic EGFR Mutant Lung Cancer Previously Treated With Osimertinib Recruiting
NCT02047747 Phase II Dacomitinib A Phase II Study of Dacomitinib in Progressive Brain Metastases Terminated
NCT01737008 Phase I Cisplatin Dacomitinib Study of Dacomitinib With Radiotherapy With and Without Cisplatin in Patients With Squamous Cell Carcinoma of the Head and Neck Completed


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