7 October 2019 - - A publication from The University of Texas, MD Anderson Cancer Center entitled, "Pan-Cancer Landscape and Functional Analysis of ERBB2 Mutations Identifies Poziotinib as a Clinically Active Inhibitor and Enhancer of T-DM1 Activity," US-based Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) said.

Spectrum is studying poziotinib in ZENITH20, a company-sponsored, open-label, single-arm, multi-center, global Phase 2 study of non-small cell lung cancer (NSCLC) patients.

Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this 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.

Spectrum received exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by Spectrum and Hanmi in several trials in multiple solid tumors.

The ZENITH20 study consists of seven cohorts of NSCLC patients. Cohorts 1 and 2 have completed enrollment of previously-treated NSCLC patients with exon 20 mutations. Cohort 3 and 4 are currently enrolling first-line NSCLC patients with exon 20 mutations.

Cohorts 1- 4 are each independently powered for a pre-specified statistical hypothesis and the primary endpoint is objective response rate.

In July 2019, three new cohorts were added to the ZENITH20 study that are all currently enrolling patients.

Cohort 5 includes previously treated or treatment-naïve NSCLC patients with EGFR or HER2 exon 20 insertion mutations. Cohort 6 includes NSCLC patients with classical EGFR mutations who progressed while on treatment with first-line osimertinib and developed an additional EGFR mutation.

Cohort 7 includes NSCLC patients with a variety of less common mutations in EGFR or HER2 exons 18-21 or the extracellular or transmembrane domains.

Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted drug products, with a primary focus in hematology and oncology.

Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals and commercialising in a competitive healthcare marketplace. Spectrum has a late-stage pipeline with novel assets that serve areas of unmet need.

This pipeline has the potential to transform the company in the near future.