Spectrum Pharmaceuticals to Present Data at 2022 ASCO Highlighting the Potential Predictive Capabilities of ctDNA as a Biomarker for Poziotinib Treatment Response
May 26 2022 - 5:01PM
Business Wire
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
November 24, 2022
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 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 Francois
Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. “We
are encouraged by these findings and look forward to further
investigate ctDNA as a potential predictive biomarker of poziotinib
treatment response.”
Poziotinib is 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 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: 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 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 Korea and China. Poziotinib is
currently being investigated by the company and Hanmi in several
mid-stage trials in multiple solid tumor indications.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biopharmaceutical company focused
on acquiring, developing, and commercializing novel and targeted
oncology therapies. Spectrum has 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.
Spectrum has 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
Spectrum Pharmaceuticals please visit www.sppirx.com.
Notice Regarding Forward-looking Statements
This press release may contain forward-looking statements
regarding future events and the future performance of Spectrum
Pharmaceuticals that involve risks and uncertainties that could
cause actual results to differ materially. These statements are
based on management's current beliefs and expectations. These
statements include, but are not limited to, statements that relate
to Spectrum’s business and its future, including certain company
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at all, the possibility that our existing and new drug candidates,
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that are described in further detail in the company's reports filed
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plan to update any such forward-looking statements and expressly
disclaims any duty to update the information contained in this
press release except as required by law.
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Robert Uhl Managing Director, ICR Westwicke 858.356.5932
robert.uhl@westwicke.com
Tom Riga Chief Executive Officer 949.788.6700
InvestorRelations@sppirx.com
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