On May 28, 2019 Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported the full enrollment of cohort 2 (N = 87) for previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations (Press release, Spectrum Pharmaceuticals, MAY 28, 2019, http://investor.sppirx.com/news-releases/news-release-details/spectrum-announces-poziotinib-zenith20-trial-her2-cohort-cohort [SID1234536606]). Topline results from this cohort are expected by mid 2020. This is the second cohort that has met enrollment target in Spectrum’s ZENITH20 trial – an open-label, multi-center, global phase 2 trial evaluating NSCLC patients with EGFR or HER2 exon 20 insertion mutations.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Our global poziotinib development program is multifaceted and progressing rapidly, which speaks to the high unmet need for patients with this type of lung cancer," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "Topline results from cohort 1 in EGFR patients are expected to be available later this year, and are intended to provide the data for regulatory submission. Our goal at Spectrum is to develop novel therapies to serve patients with high unmet medical need, and we are diligently pursuing this goal with our poziotinib program."
The ZENITH20 trial consists of four cohorts of NSCLC patients with EGFR or HER2 exon 20 insertion mutations, with each cohort independently powered for a pre-specified statistical hypothesis. There are two cohorts in the previously-treated NSCLC setting, cohorts 1 (EGFR) and 2 (HER2), and two in the first-line setting, cohorts 3 (EGFR) and 4 (HER2). 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.
"The ZENITH20 trial is a critically important investigation for NSCLC patients harboring exon 20 insertion mutations as these patients have a poor prognosis and very limited treatment options," said Francois Lebel, M.D., F.R.C.P.C., Chief Medical Officer of Spectrum Pharmaceuticals. "A new and targeted treatment is urgently needed. Our brisk enrollment rates are very encouraging for such rare mutations and a strong testimony to the strength of our team."
About Poziotinib
Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR (HER1) 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.