Therapy Detail

Therapy Name Poziotinib
Therapy Description

Poziotinib (HM781-36B) is a pan-ErbB inhibitor that inhibits EGFR (HER1), ERBB2 (HER2) and ERBB4 (HER4), thereby reducing proliferation of tumor cells that overexpress these receptors (PMID: 21306821).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Poziotinib HM781-36B|NOV120101 EGFR Inhibitor (Pan) 38 HER inhibitor (Pan) 6 Poziotinib (HM781-36B) is a pan-ErbB inhibitor that inhibits EGFR (HER1), ERBB2 (HER2) and ERBB4 (HER4), thereby reducing proliferation of tumor cells that overexpress these receptors (PMID: 21306821).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 E812K lung adenocarcinoma predicted - sensitive Poziotinib Phase II Actionable In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in stable disease in a patient with lung adenocarcinoma harboring ERBB2 (HER2) E812K (PMID: 30149884; NCT02979821). 30149884
ERBB2 G776delinsVC lung adenocarcinoma predicted - sensitive Poziotinib Phase II Actionable In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in 1 partial response and 1 stable disease in 2 patients with lung adenocarcinoma harboring ERBB2 (HER2) G776delinsVC (PMID: 30149884; NCT02979821). 30149884
ERBB2 Y772_A775dup non-small cell lung carcinoma predicted - sensitive Poziotinib Clinical Study Actionable In a retrospective study, Poziotinib (HM781-36B) treatment resulted in an objective response rate of 33% (1/3) in non-small cell lung cancer patients harboring ERBB2 (HER2) Y772_A775dup (reported as (A775_G776insYVMA) (PMID: 30527195). 30527195
ERBB2 G776delinsVV Advanced Solid Tumor sensitive Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited growth of a transformed cell line expressing ERBB2 (HER2) G776delinsVV in culture (PMID: 29686424). 29686424
KRAS mutant stomach cancer resistant Poziotinib Preclinical Actionable In a preclinical study, a human gastric cancer cell line harboring a KRAS mutation demonstrated resistance to Poziotinib (PMID: 21306821). 21306821
ERBB2 Y772_A775dup lung cancer sensitive Poziotinib Preclinical Actionable In a preclinical study, Poziotinib (HM781-36B) induced regression of lung tumors in mouse models harboring ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA), with no signs of progression at 12 weeks (PMID: 29686424). 29686424
ERBB2 Y772_A775dup ERBB2 C805S Advanced Solid Tumor resistant Poziotinib Preclinical - Cell culture Actionable In a preclinical study, ERBB2 (HER2) C805S was identified as a secondary mutation in transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) that acquired resistance to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup lung adenocarcinoma predicted - sensitive Poziotinib Phase II Actionable In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in 1 partial response, 1 stable disease, and 1 progressive disease in 3 patients with lung adenocarcinoma harboring ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) (PMID: 30149884; NCT02979821). 30149884
ERBB2 amp stomach cancer sensitive Poziotinib Preclinical Actionable In a preclinical study, Poziotinib suppressed cell growth, decreased phosphorylation of downstream signaling molecules, and induced apoptosis of human gastric cancer cells harboring ERBB2 (HER2) amplification (PMID: 21306821). 21306821
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive Poziotinib Phase II Actionable In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in a median progression-free survival of 4.04 months, and a disease control rate of 75.49% (77/102; 20 partial responses) in heavily-treated Erbb2 (Her2)-positive breast cancer patients (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 237O; NCT02418689). detail...
ERBB2 G778_P780dup Advanced Solid Tumor sensitive Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited growth of a transformed cell line expressing ERBB2 (HER2) G778_P780dup (reported P780insGSP) in culture (PMID: 29686424). 29686424
Unknown unknown Advanced Solid Tumor not applicable Poziotinib Phase I Actionable In a Phase I trial, Poziotinib (HM781-36B) displayed favorable pharmacokinetics in patients with advanced solid tumors (PMID: 25377158). 25377158
ERBB2 G776delinsVC Advanced Solid Tumor sensitive Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited growth of a transformed cell line expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 29686424). 29686424
ERBB2 Y772_A775dup Advanced Solid Tumor sensitive Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited ERBB2 (HER2) phosphorylation and growth of a transformed cell line expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) in culture (PMID: 29686424). 29686424
ERBB2 G776delinsVC ERBB2 C805S Advanced Solid Tumor resistant Poziotinib Preclinical - Cell culture Actionable In a preclinical study, ERBB2 (HER2) C805S was identified as a secondary mutation in transformed cells expressing ERBB2 (HER2) G776delinsVC that acquired resistance to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC non-small cell lung carcinoma predicted - sensitive Poziotinib Clinical Study Actionable In a retrospective study, Poziotinib (HM781-36B) treatment resulted in an objective response rate of 50% (1/2) in non-small cell lung cancer patients harboring ERBB2 (HER2) G776delinsVC (PMID: 30527195). 30527195
Clinical Trial Phase Therapies Title Recruitment Status
NCT03066206 Phase II Poziotinib Poziotinib in EGFR Exon 20 Mutant Advanced Non-Small Cell Lung Cancer (NSCLC) Recruiting
NCT03318939 Phase II Poziotinib Phase 2 Study of Poziotinib in Patients With NSCLC With EGFR or HER2 Exon 20 Insertion Mutation Recruiting
NCT03744715 Phase II Poziotinib A Study to Allow Continued Treatment of Patients Who Have Participated in a Spectrum-Sponsored Poziotinib Study Recruiting
NCT02659514 Phase II Poziotinib Study of Poziotinib in Patients With HER2-Positive Metastatic Breast Cancer Active, not recruiting