Spectrum Pharmaceuticals has announced full enrollment of cohort 1 (N=87) 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 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.
Spectrum Pharmaceuticals president and CEO Joe Turgeon said: “The rapid rate at which we enrolled our Phase 2 previously treated EGFR exon 20 insertion mutations cohort speaks to the critical unmet medical need and demonstrates that the poziotinib program is aggressively advancing,
“We are pleased with the results seen in smaller poziotinib trials and look forward to data from this larger, multi-center trial in the second half of the year.”
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 (ORR). Additional endpoints include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) and safety.
Spectrum Pharmaceuticals chief medical officer Dr Francois Lebel said: “Full enrollment of the first cohort marks an important milestone as this cohort is intended to provide the data required for the NDA filing.
“Our poziotinib development program is investigating the treatment of exon 20 mutations across tumor types as these mutations are among the most difficult-to-treat and currently have no targeted FDA-approved therapies, leaving patients and physicians with very limited options.”
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.
Source: Company Press Release