Spectrum Pharmaceuticals to Present Data at 2022 ASCO Highlighting the Potential Predictive Capabilities of ctDNA as a Biomarker for Poziotinib Treatment Response
ASCOClinical ResultCollaborateAntibodySmall molecular drugFast Track
HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced additional exploratory data for poziotinib in non-small cell lung cancer (NSCLC) patients harboring HER2 exon 20 insertion mutations at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago from June 3-7.
In ppoziotinibtreated patients with aadvanced NSCLCharboring HHER2 exon 20insertion mutations, baseline ctDNA presence was associated with the ttumortissue genotyping with a concordance of 95%. In patients who responded to treatment, reduced ctDNA levels were associated with ttumormass reduction by central imaging. Increases in ctDNA were observed prior to confirmation of ttumorescape, or disease progression.
“This early data suggests that a reduction in ctDNA may be a predictor of response to treatment with ppoziotinib” said Francois Lebel, M.D., Chief Medical Officer of SSpectrum Pharmaceuticals “We are encouraged by these findings and look forward to further investigate ctDNA as a potential predictive biomarker of ppoziotinibtreatment response.”
PPoziotinibis currently under review by the U.S. Food and Drug Administration (FDA) with a PDUFA date of November 24, 2022 and has received Fast Track designation from the agency.
Session title and information for the poster is listed below and is available on the ASCO online itinerary planner.
Circulating tumor DNA (ctDNA) in HHER2 exon 20insertion mutations and responses in NNSCLCHHER2 exon 20insertion treated with ppoziotinib
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and TTumorBiology
Session Date and Time: Sunday, June 5, 2022, 8-11 a.m. CDT, 6-9 a.m. PT
Location: McCormick Place, Chicago IL
Abstract: 3051 / Poster: 43
Copies of the presentation will be available on Spectrum's website at following presentation at the meeting.
About the ZENITH20 Clinical Trial
The ZENITH20 study is a multicenter, open-label Phase 2 trial, evaluating ppoziotinibin patients with aadvanced or metastatic NSCLCpatients with EEGFRor HHER2 exon 20insertion mutations. The trial is comprised of 7 independent cohorts. Cohorts 1 - 4 were each independently powered for a pre-specified statistical hypothesis with a primary endpoint of ORR, or objective response rate evaluated by independent review committee (RECIST v1.1). Cohorts 5 - 7 are exploratory. Secondary outcome measures are disease control rate, duration of response, progression-free survival, and safety and tolerability. The patients’ quality of life is also measured and assessed throughout. Cohort 4 includes first-line NNSCLCpatients with HHER2 exon 20mutations and cohort 5 includes previously treated or treatment-naïve NNSCLCpatients with EEGFRor HHER2 exon 20insertion mutations.
About PPoziotinib
PPoziotinibis a novel, oral eepidermal growth factor receptortyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EEGFRas well as HHER2and HHER4 Importantly this, in turn, leads to the inhibition of the proliferation of ttumorcells that overexpress these receptors. Mutations or overexpression/amplification of EEGFR family receptorshave been associated with a number of different ccancers including nnon-small cell lung cancer (NSCLC) bbreast cancer and ggastric cancer HHER2 exon 20insertion mutations are a rare subset accounting for approximately 2-4% in NNSCLC There is no approved therapy for either treatment-naïve or previously treated NNSCLCwith HHER2 exon 20insertion mutations. The company holds an exclusive license from HHanmi Pharmaceuticalto develop, manufacture, and commercialize ppoziotinibworldwide, excluding Korea and China. PPoziotinibis currently being investigated by the company and Hanmi in several mid-stage trials in multiple ssolid tumorindications.
SSpectrum Pharmaceuticalsis a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies. SSpectrumhas a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals and commercializing in a competitive healthcare marketplace. SSpectrumhas a late-stage pipeline with novel assets that serve areas of unmet need. This pipeline has the potential to transform the company in the near future. For additional information on SSpectrum Pharmaceuticalsplease visit www.sppirx.com.
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