Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company
Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company
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Poziotinib

Poziotinib is a novel, oral, quinazoline-based tyrosine kinase inhibitor that irreversibly blocks signaling through the HER family of tyrosine-kinase receptors including HER1 (erbB1; EGFR), HER2 (erbB2), and HER4 (erbB4), as well as HER receptor mutations; this in turn can lead to inhibition of the proliferation of tumor cells that overexpress these receptors.

Target Indications

  • Currently under development for lung, breast, gastric, head and neck cancer

Route of Administration

  • Oral

Mode of Action

  • A novel, irreversible tyrosine kinase inhibitor

Status

  • In October 2017, Spectrum initiated a multicenter Phase 2 Trial of poziotinib in Non-Small Cell Lung Cancer (NSCLC) patients with exon 20 insertion mutation in EGFR or HER2.
  • Preliminary data from 11 patients in the University of Texas MD Anderson Cancer Center trial was reported at the World Conference on Lung Cancer in Japan and showed an Objective Response Rate of 73%. Toxicities have included rash. diarrhea, paronychia and mucocitis.
  • An investigator sponsored trial has been initiated at the University of Texas MD Anderson Cancer Center in non-small cell lung cancer patients with EGFR exon 20 insertion mutations.
  • Spectrum initiated a Phase 2 breast cancer program in the U.S., based on Phase 1 efficacy data in breast cancer patients who had failed multiple other HER2-directed therapies.
    Click here to view trial details on Clinical Trials.gov
  • Currently poziotinib is also being investigated in several phase 2 studies that are ongoing in Korea in multiple tumor types.
  • In March 2015, Spectrum entered into a licensing agreement with Hanmi Pharmaceutical Co., Ltd. to develop, manufacture and commercialize poziotinib worldwide excluding Korea and China.

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Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company

Market Opportunities

Poziotinib

Non Small Cell Lung Cancer With Exon 20 Insertion Mutation

Currently being tested for a rare form of Non Small Cell Lung Cancer with exon 20 insertion mutation where there is significant unmet .medical need. These patients have a Progression Free Survival index of ~1.8 months.

Breast Cancer

In the U.S., breast cancer is the second most common cancer in women after skin cancer. In 2016, it is estimated that there will be 246,660 new cases of female breast cancer and an estimated 40,450 people will die of this disease. It is estimated there are over 3 million women living with breast cancer, and 89.7% of these women will survive at least 5 years.

Source: Cancer.gov Website, NIH Surveillance, Epidemiology and End Result Program