Spectrum also announced that it has dosed the first patient in the expanded patient population.
The poziotinib NSCLC clinical programme for patients with EGFR or HER2 exon 20 mutations currently consists of a Phase 2 pivotal, Spectrum-sponsored, multi-centre global study (ZENITH20) with active sites in the United States and future centers planned in Canada and Europe, and a Phase 2 investigator-initiated study at the University of Texas MD Anderson Cancer Center.
Spectrum's ZENITH20 study now includes four cohorts, with each cohort being an independent study with pre-specified statistical hypotheses and statistical power.
The protocol amendment incorporating the two new cohorts was designed based on input from the FDA. The two previously-treated cohorts will enroll up to 87 patients each, and the two first-line cohorts will enroll up to 70 patients each.
For each cohort, the primary endpoint is objective response rate; the secondary endpoints are disease control rate, duration of response, safety and tolerability; and the exploratory endpoints are progression-free survival and quality of life.
Poziotinib is a novel, orally administered 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 an exclusive license to develop, manufacture, and commercialize worldwide excluding Korea and China from Hanmi Pharmaceuticals.
Spectrum Pharmaceuticals is a biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in hematology and oncology.
The company 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.
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