Therapy Detail

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) 6 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
EGFR E709_T710delinsD EGFR L792F Advanced Solid Tumor sensitive Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited growth of transformed cells expressing EGFR E709_T710delinsD and EGFR L792F in culture (PMID: 27913578). 27913578
EGFR P772_H773insPNP lung adenocarcinoma sensitive Dacomitinib Preclinical - Patient cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited EGFR phosphorylation and growth of a patient-derived lung adenocarcinoma cell line harboring EGFR P772_H773insPNP in culture (PMID: 28363995). 28363995
EGFR E709K Advanced Solid Tumor sensitive Dacomitinib Preclinical Actionable In a preclinical study, transformed cells expressing EGFR E709K demonstrated increased sensitivity to second-generation EGFR inhibitors including Vizimpro (dacomitinib) in culture, when compared to first and third-generation inhibitors (PMID: 26206867). 26206867
ERBB2 M774delinsWLV lung adenocarcinoma sensitive Dacomitinib Phase II 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
EGFR amp PTEN loss glioblastoma multiforme decreased response Dacomitinib Preclinical - Pdx & cell culture Actionable In a preclinical study, patient-derived EGFR amplified glioblastoma cells harboring PTEN loss demonstrated reduced sensitivity to Vizimpro (dacomitinib) induced growth inhibition in culture and in xenograft models (PMID: 25939761). 25939761
EGFR G719S lung non-small cell carcinoma sensitive Dacomitinib Phase III Actionable In Phase III clinical trials, patients with NSCLC tumors harboring an EGFR G719X (X=A, C, or S) mutation responded to EGFR tyrosine kinase inhibitors including Vizimpro (dacomitinib) (PMID: 24857124). 24857124
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
EGFR amp glioblastoma multiforme sensitive Dacomitinib Preclinical - Pdx & cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited Egfr signaling and survival of patient-derived EGFR amplified glioblastoma cells in culture and in intracranial xenograft models (PMID: 25939761). 25939761
EGFR A767_V769dup Advanced Solid Tumor resistant Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing EGFR A767_V769dup (also referred to as V769_D770insASV) demonstrated resistance to Vizimpro (dacomitinib) in culture (PMID: 28363995). 28363995
EGFR L858R lung non-small cell carcinoma sensitive Dacomitinib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (ARCHER 1050) that supported FDA approval, treatment with Vizimpro (dacomitinib) as first-line therapy in patients with non-small cell lung cancer harboring an EGFR exon 19 deletion or EGFR L858R resulted in an improved median progression-free survival (mPFS) of 14.7 months compared to 9.2 months with Iressa (gefitinib), with a mPFS of 16.5 months with dacomitnib vs. 9.2 months with Iressa (gefitinib) among patients with EGFR L858R (PMID: 28958502; NCT01777421). detail... 28958502 detail...
EGFR L858R lung non-small cell carcinoma sensitive Dacomitinib Phase II Actionable In a Phase II clinical trial, 74% (34/46) of patients with EGFR exon 19 or 21 mutant lung cancers had partial response (PFS average= 17 months) to first line treatment with Vizimpro (dacomitinib) (J Clin Oncol 30, 2012 (suppl; abstr 7530); NCT00818441). detail...
EGFR L858R lung non-small cell carcinoma sensitive Dacomitinib Guideline Actionable Vizimpro (dacomitinib) is included in guidelines as first-line therapy for patients with advanced or metastatic non-small cell lung cancer harboring sensitizing EGFR mutations, such as L858R (NCCN.org). detail...
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 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 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 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
EGFR E746_A750del lung non-small cell carcinoma sensitive Dacomitinib Phase II Actionable In a Phase II clinical trial, 74% (34/46) of patients with EGFR exon 19 or 21 mutant lung cancers had partial response (PFS average= 17 months) to first line treatment with Vizimpro (dacomitinib) (J Clin Oncol 30, 2012 (suppl; abstr 7530)). detail...
EGFR S768_D770dup Advanced Solid Tumor resistant Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing EGFR S768_D770dup (also referred to as D770_N771insSVD) demonstrated resistance to Vizimpro (dacomitinib) in culture (PMID: 28363995). 28363995
EGFR exon 19 del lung non-small cell carcinoma sensitive Dacomitinib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (ARCHER 1050) that supported FDA approval, treatment with Vizimpro (dacomitinib) as first-line therapy in patients with non-small cell lung cancer harboring an EGFR exon 19 deletion or EGFR L858R resulted in an improved median progression-free survival (mPFS) of 14.7 months compared to 9.2 months with Iressa (gefitinib), with a mPFS of 12.3 months with dacomitnib vs. 9.8 months with Iressa (gefitinib) among patients with EGFR exon 19 deletions (PMID: 28958502; NCT01777421). detail... 28958502 detail...
EGFR exon 19 del lung non-small cell carcinoma sensitive Dacomitinib Guideline Actionable Vizimpro (dacomitinib) is included in guidelines as first-line therapy for patients with advanced or metastatic non-small cell lung cancer harboring sensitizing EGFR mutations, such as EGFR exon 19 deletions (NCCN.org). detail...
EGFR exon 19 del lung non-small cell carcinoma sensitive Dacomitinib Phase II Actionable In a Phase II clinical trial, 74% (34/46) of patients with EGFR exon 19 or 21 mutant lung cancers had partial response (PFS average= 17 months) to first line treatment with Vizimpro (dacomitinib) (J Clin Oncol 30, 2012 (suppl; abstr 7530); NCT00818441). detail...
ERBB2 amp lung adenocarcinoma no benefit Dacomitinib Phase II 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 G776delinsVC Advanced Solid Tumor sensitive 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
EGFR wild-type glioblastoma multiforme no benefit Dacomitinib Preclinical - Pdx & cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) did not inhibit Egfr signaling or survival of patient-derived EGFR wild-type glioblastoma cells in culture and in intracranial xenograft models (PMID: 25939761). 25939761
EGFR E709_T710delinsD Advanced Solid Tumor sensitive Dacomitinib Preclinical Actionable In a preclinical study, transformed cells expressing EGFR E709_T710delinsD demonstrated increased sensitivity to second-generation EGFR inhibitors including Vizimpro (dacomitinib) in culture, when compared to first and third-generation inhibitors (PMID: 26206867). 26206867
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
EGFR act mut lung non-small cell carcinoma sensitive Dacomitinib Phase II Actionable In a Phase II clinical trial, progression-free survival at 4 months was 95.5% in patients with EGFR-mutant non-small cell lung cancer following treatment with Vizimpro (dacomitinib), compared to 76.8% in the overall treatment population (PMID: 25456362). 25456362
EGFR act mut lung non-small cell carcinoma sensitive Dacomitinib Guideline Actionable Vizimpro (dacomitinib) is included in guidelines as first-line therapy for patients with metastatic non-small cell lung cancer harboring sensitizing EGFR activating mutations (PMID: 30715168, PMID: 30285222; ESMO.org). detail... 30285222 30715168
EGFR act mut lung non-small cell carcinoma sensitive Dacomitinib Phase III Actionable In a Phase III (ARCHER 1050) trial, Vizimpro (dacomitinib) demonstrated superior efficacy compared to Iressa (gefitinib) as first-line therapy in non-small cell lung cancer patients harboring EGFR activating mutations (exon 19 deletion or L858R), resulting in prolonged overall survival (34.1 vs 26.8 months, HR=0.76, p=0.0438) (PMID: 29864379; NCT01774721). detail... 29864379
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 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
EGFR D770delinsGY Advanced Solid Tumor sensitive Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited EGFR phosphorylation and growth of transformed cells expressing EGFR D770delinsGY in culture (PMID: 28363995). 28363995
ERBB2 G778_P780dup Advanced Solid Tumor sensitive 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
EGFR S768I lung non-small cell carcinoma sensitive Dacomitinib Guideline Actionable Vizimpro (dacomitinib) is included in guidelines as first-line therapy for patients with advanced or metastatic non-small cell lung cancer harboring sensitizing EGFR mutations, such as S768I (NCCN.org). detail...
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
EGFR G719C lung non-small cell carcinoma sensitive Dacomitinib Phase III Actionable In Phase III clinical trials, patients with NSCLC tumors harboring an EGFR G719X (X=A, C, or S) mutation responded to EGFR tyrosine kinase inhibitors including Vizimpro (dacomitinib) (PMID: 24857124). 24857124
ERBB2 G778_P780dup lung adenocarcinoma sensitive Dacomitinib Phase II 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
EGFR G719A lung non-small cell carcinoma sensitive Dacomitinib Phase III Actionable In Phase III clinical trials, patients with NSCLC tumors harboring an EGFR G719X (X=A, C, or S) mutation responded to EGFR tyrosine kinase inhibitors including Vizimpro (dacomitinib) (PMID: 24857124). 24857124
EGFR G719X lung non-small cell carcinoma sensitive Dacomitinib Guideline Actionable Vizimpro (dacomitinib) is included in guidelines as first-line therapy for patients with advanced or metastatic non-small cell lung cancer harboring sensitizing EGFR mutations, such as G719 mutations (NCCN.org). detail...
EGFR exon 19 ins lung non-small cell carcinoma sensitive Dacomitinib Guideline Actionable Vizimpro (dacomitinib) is included in guidelines as first-line therapy for patients with advanced or metastatic non-small cell lung cancer harboring sensitizing EGFR mutations, such as exon 19 insertions (NCCN.org). detail...
EGFR exon 20 ins Advanced Solid Tumor resistant Dacomitinib Preclinical Actionable In a preclinical study, transformed cells expressing an EGFR exon 20 insertion mutation had decreased response to Vizimpro (dacomitinib) compared to other EGFR activating mutations, with inhibitory doses exceeding clinically attainable levels (PMID: 18089823, PMID: 21764376). 18089823 21764376
ERBB2 Y772_A775dup Advanced Solid Tumor decreased response 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
EGFR L861Q lung non-small cell carcinoma sensitive Dacomitinib Guideline Actionable Vizimpro (dacomitinib) is included in guidelines as first-line therapy for patients with advanced or metastatic non-small cell lung cancer harboring sensitizing EGFR mutations, such as L861Q (NCCN.org). detail...
EGFR D770delinsGY EGFR C797S Advanced Solid Tumor resistant Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing an EGFR D770delinsGY and EGFR C797S double mutation demonstrated resistance to Vizimpro (dacomitinib) in culture (PMID: 28363995). 28363995
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
EGFR G719A Advanced Solid Tumor sensitive Dacomitinib Preclinical Actionable In a preclinical study, transformed cells expressing EGFR G719A demonstrated increased sensitivity to second-generation EGFR inhibitors including Vizimpro (dacomitinib) in culture, when compared to first and third-generation inhibitors (PMID: 26206867). 26206867
EGFR Y764_V765insHH Advanced Solid Tumor resistant Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing EGFR Y764_V765insHH demonstrated resistance to Vizimpro (dacomitinib) in culture (PMID: 28363995). 28363995
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
EGFR N771_H773dup lung adenocarcinoma sensitive Dacomitinib Preclinical - Patient cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited EGFR phosphorylation and growth of a patient-derived lung adenocarcinoma cell line harboring EGFR N771_H773dup (also referred to as H773_V774insNPH) in culture (PMID: 28363995). 28363995
EGFR D770delinsGY EGFR T790M Advanced Solid Tumor resistant Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, acquisition of EGFR T790M was associated with resistance to Vizimpro (dacomitinib) in transformed cells expressing EGFR D770delinsGY (PMID: 28363995). 28363995

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Clinical Trial Phase Therapies Title Recruitment Status
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
NCT01112527 Phase II Dacomitinib PF-00299804 in Adult Patients With Relapsed/Recurrent Glioblastoma Completed
NCT01858389 Phase II Dacomitinib A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer Completed
NCT03755102 Phase I Dacomitinib A Study of Dacomitinib in Patients With Metastatic EGFR Mutant Lung Cancer Previously Treated With Osimertinib Recruiting
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


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