Spectrum Pharmaceuticals to Present Data at 2022 ASCO Highlighting the Potential Predictive Capabilities of ctDNA as a Biomarker for Poziotinib Treatment Response
Reduced circulating tumor DNA (ctDNA) and circulating free DNA (cfDNA) levels were associated with tumor shrinkage in patients that responded to poziotinib treatment
Poziotinib has received Fast Track designation from FDA and a Prescription Drug User Fee Act (PDUFA) date of
In poziotinib treated patients with advanced NSCLC harboring HER2 exon 20 insertion mutations, baseline ctDNA presence was associated with the tumor tissue genotyping with a concordance of 95%. In patients who responded to treatment, reduced ctDNA levels were associated with tumor mass reduction by central imaging. Increases in ctDNA were observed prior to confirmation of tumor escape, or disease progression.
“This early data suggests that a reduction in ctDNA may be a predictor of response to treatment with poziotinib,” said
Poziotinib is currently under review by the
Session title and information for the poster is listed below and is available on the ASCO online itinerary planner.
Circulating tumor DNA (ctDNA) in HER2 exon 20 insertion mutations and responses in NSCLC HER2 exon 20 insertion treated with poziotinib
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time:
Location:
Abstract: 3051 / Poster: 43
Copies of the presentation will be available on Spectrum's website at https://investor.sppirx.com/events-and-presentations following presentation at the meeting.
About the ZENITH20 Clinical Trial
The ZENITH20 study is a multicenter, open-label Phase 2 trial, evaluating poziotinib in patients with advanced or metastatic NSCLC patients with EGFR or HER2 exon 20 insertion 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 NSCLC patients with HER2 exon 20 mutations and cohort 5 includes previously treated or treatment-naïve NSCLC patients with EGFR or HER2 exon 20 insertion mutations.
About Poziotinib
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, 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. HER2 exon 20 insertion mutations are a rare subset accounting for approximately 2-4% in NSCLC. There is no approved therapy for either treatment-naïve or previously treated NSCLC with HER2 exon 20 insertion mutations. The company holds an exclusive license from Hanmi Pharmaceutical to develop, manufacture, and commercialize poziotinib worldwide, excluding
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