2 January 2019 - - US-based biotechnology company Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) has achieved full enrollment of cohort 1 for previously treated Non-Small Cell Lung Cancer (NSCLC) patients with EGFR exon 20 insertion mutations with sites across the US, Europe, and Canada, the company said.

The EGFR previously treated cohort is part of the ZENITH20 trial an open-label, multi-center, global Phase 2 trial evaluating NSCLC patients with EGFR or HER2 exon 20 insertion mutations. Results from this cohort are expected by the second half of 2019.

The EGFR previously treated cohort is the first to fully enroll in the ZENITH20 trial. This study consists of four cohorts, each of which is independently powered for a pre-specified statistical hypothesis.

There are two cohorts in the previously-treated NSCLC setting and two in the first-line setting. The primary endpoint is objective response rate. Additional endpoints include duration of response, disease control rate, progression-free survival and safety.

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.

The full poziotinib targeted therapy clinical program is focused on four development areas for EGFR and HER2 mutations, including previously treated NSCLC, first-line NSCLC, treatment of other solid tumors and combination therapy.

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.

Spectrum Pharmaceuticals is a biotechnology company focused on acquiring, developing, and commercialising drug products, with a primary focus in hematology and oncology.