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Poziotinib

Poziotinib is an investigational drug not yet approved by the FDA.

Poziotinib is an investigational, orally administered, irreversible tyrosine kinase inhibitor targeting EGFR and HER2 with
exon 20 insertion mutations.

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Poziotinib is designed to be small and flexible.

EGFR and HER2 are part of a larger family of receptors.
The epidermal growth factor receptor (EGFR) family of proteins comprise the structurally related receptors EGFR, HER2, HER3, and HER4. Members with kinase domains, like EGFR, are activated upon ligand binding and dimerization - either with another EGFR, or with other members such as HER2.

A variety of mutations in EGFR result in their constant activation, and are associated with certain cancers.

Among the known activating mutations in EGFR and HER2,
exon 20 insertions add additional amino acids to the protein sequence causing a conformational change, heavily restricting access to the drug binding pocket of the kinase active site.

Preclinical studies suggest that poziotinib can access the restricted binding pocket caused by these exon 20 insertion mutations and may help inhibit its kinase activity.

Preclinical studies suggest that poziotinib can access the restricted binding pocket caused by these exon 20 insertion mutations and may help inhibit its kinase activity.

In pre-clinical models of cancer, poziotinib was shown to inhibit kinase activity of EGFR and HER2 with exon 20 insertion mutations, inhibiting proliferation, leading to cancer cell death.

More About Poziotinib

Development Indications

Non Small Cell Lung Cancer
  • SPI-POZ-202 (Phase 2): EGFR and HER2 Exon 20 Insertion Mutations Locally Advanced or Metastatic NSCLC
Breast Cancer
  • SPI-POZ-201 (Phase 2): HER2+ Metastatic Breast Cancer
  • SPI-POZ-101 (Phase 1b) Combination With T-DM1 in HER2+ Breast Cancer

MOA Video

Latest News on Poziotinib

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Sep 24, 2018

Spectrum Pharmaceuticals Announces Release of Updated Poziotinib Data From MD Anderson Phase 2 Study in Non-Small Cell Lung Cancer Patients

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Sep 5, 2018

Spectrum Pharmaceuticals Announces Release of Poziotinib Abstract as Part of the IASLC 19th World Conference on Lung Cancer

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May 3, 2018

Exclusive Licensing Agreement on Certain Methods of Use of Poziotinib with The University of Texas MD Anderson Cancer Center

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May 1, 2018

Spectrum Enters into a Next-Generation Sequencing Companion Diagnostic Partnership with Thermo Fisher Scientific

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Apr 23, 2018

Publication of Poziotinib Data in Nature Medicine

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Apr 17, 2018

Data Showing Poziotinib Overcomes De Novo Resistance of HER2 Exon 20 Insertion Mutations in NSCLC and Other Cancers at the American Association for Cancer Research (AACR) in Chicago

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Apr 10, 2018

Update of MD Andersonís Phase 2 Data Studying Poziotinib in EGFR Exon 20 Mutant Non-Small Cell Lung Cancer Patients

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Oct 30, 2017

Initiation of a Multicenter Phase 2 Trial of Poziotinib in Non-Small Cell Lung Cancer (NSCLC) Patients with Exon 20 Insertion Mutation in EGFR or HER2

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Oct 17, 2017

Poziotinib Data in Non-Small-Cell Lung Cancer (NSCLC) Presented at the 18th IASLC World Conference on Lung Cancer in Yokohama, Japan, October 15-18, 2017

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Mar 30, 2017

Initiation of a Phase 2 Trial of Poziotinib in Non-Small Cell Lung Cancer Patients with EGFR Exon 20 Insertion Mutations

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Dec 8, 2016

Spectrum Highlights Promising Preclinical Data Evaluating Poziotinib in Lung Cancer at the 17th IASLC World Conference on Lung Cancer

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Dec 5, 2016

Abstracts on Poziotinib posted at the San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas, December 6-10, 2016

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