On December 8, 2016 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology reported the oral presentation of data from a preclinical study evaluating poziotinib in lung cancer by scientists from MD Anderson Cancer Center at the 17th International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer which took place in Vienna, Austria, December 4-7, 2016 (Press release, Spectrum Pharmaceuticals, DEC 8, 2016, View Source [SID1234517006]).
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"We are honored to have an oral presentation on poziotinib presented at the 17th IASLC World Conference," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "These results show that poziotinib may work in a subset of non-small cell lung cancer patients that have exon-20 mutations. Tumors with exon-20 mutations have generally not been responsive to several other EGFR inhibitors. However, due to its smaller size poziotinib is hypothesized to inhibit cell growth of EGFR exon 20 insertions. These early results are very encouraging and have the potential to be a transforming therapy for patients who have little or no options and poor prognosis with median progression free survival of 1.5 months. We are working closely with the team at MD Anderson Cancer Center in expediting this research and evaluating ways of serving the unmet medical need in this area."
Abstract/Oral Presentation #6203: Drug Repurposing to Overcome De Novo Resistance of Non-Traditional EGFR Mutations: Poziotinib inhibits EGFR exon 20 insertion mutations in NSCLC
EGFR exon 20 insertions induce a shift in the structure of cancer cells that prevents binding of many EGFR inhibitors. In vitro, Ba/F3 cells with EGFR exon 20 insertions were screened against several EGFR inhibitors including erlotinib, gefitinib, afatinib, dacomitinib, neratinib, poziotinib, ibrutinib rocilentinib, EGF816, and osimertinib. In Ba/F3 cells with EGFR exon 20 insertions, most of the TKIs failed to inhibit growth of EGFR exon 20 insertions with IC50 values above 100nM. However, poziotinib significantly inhibited cell growth of all EGFR exon 20 insertions tested with an average IC50 value of 2.9nM, as compared to osimertinib and rocilentinib (IC50 values =103nM and 850nM, respectively). In vivo, poziotinib reduced ≥80% of tumor burden in multiple mouse models. Computational modeling suggests that its smaller structure gives poziotinib the potential to overcome the steric hindrance of the drug binding pocket. An investigator sponsored clinical trial testing poziotinib in EGFR exon 20 mutant NSCLC patients is expected to begin enrollment soon.
About Poziotinib
Poziotinib is a novel, oral pan-HER inhibitor that irreversibly blocks signaling through the Epidermal Growth Factor Receptor (EGFR, HER) Family of tyrosine-kinase receptors, including HER1 (erbB1; EGFR), HER2 (erbB2), and HER4 (erbB4), and importantly, also HER receptor mutations; this, in turn, 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. Currently, Poziotinib is being investigated by Hanmi in several mid-stage trials in different solid tumor indications including HER2-positive breast cancer. (Phase 2 sponsored by National OncoVenture, a funding initiative by the Korean government’s National Cancer Center).