Spectrum Pharmaceuticals Announces Initiation of a Phase 2 Trial of Poziotinib in Non-Small Cell Lung Cancer Patients with EGFR Exon 20 Insertion Mutations
- Encouraging results observed in patient with exon 20 insertion mutation treated with poziotinib on a compassionate basis.
- Phase 2 trial will evaluate Objective Response Rate (ORR) as the primary endpoint.
- Top-line results are expected before year-end.
- Spectrum has worldwide rights to poziotinib, excluding Korea and China.
"We are excited to be collaborating with a prominent institution to
continue to develop our potential best-in-class, novel, pan-HER
inhibitor, poziotinib," said
"Patients who suffer from this rare cancer have very few options for treatment and a poor prognosis with median progression free survival (PFS) of less than 2 months," said John Heymach, M.D., Ph.D., Chairman, Professor, and David Bruton Junior Chair in Cancer Research, Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center. "Recently we saw promising preclinical results from poziotinib and based on our preclinical studies, drug screening, and computational modeling, we believe that poziotinib could potentially overcome steric hindrance of the drug binding pocket induced by the exon 20 insertion mutations. We have already seen encouraging results in a patient with this mutation who was recently treated with poziotinib on a compassionate basis. We look forward to further results from this trial later this year."
Poziotinib is a novel, oral pan-HER inhibitor that irreversibly blocks
signaling through the Epidermal Growth Factor Receptor (EGFR, HER)
Family of tyrosine-kinase receptors, including HER1 (erbB1; EGFR), HER2
(erbB2), and HER4 (erbB4), and importantly, also HER receptor mutations;
this, in turn, leads to the inhibition of the proliferation of tumor
cells that overexpress these receptors. Mutations or
overexpression/amplification of EGFR family receptors have been
associated with a number of different cancers, including non-small cell
lung cancer (NSCLC), breast cancer, and gastric cancer. Currently,
poziotinib is being investigated by Hanmi in several mid-stage trials in
different solid tumor indications including HER2-positive breast cancer.
(Phase 2 sponsored by National OncoVenture, a funding initiative by the
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in Hematology and Oncology. Spectrum currently markets six hematology/oncology drugs, and has an advanced stage pipeline that has the potential to transform the Company. Spectrum's strong track record for in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.
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