Company Website:
http://www.sppirx.com
HENDERSON, Nev. -- (Business Wire)
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology Company
with fully integrated commercial and drug development operations with a
primary focus in Hematology and Oncology, announced the release of an
abstract from a clinical study evaluating poziotinib in EGFR Exon 20
Mutant Non-Small Cell Lung Cancer (NSCLC) by scientists from The
University of Texas MD Anderson Cancer Center, the sponsor of the trial.
This abstract contains limited data as of the submission deadline of
June 21, 2017. Additional data from their clinical experience and the
ongoing Phase 2 study will be released in an oral presentation at the
18th International Association for the Study of Lung Cancer (IASLC)
World Conference on Lung Cancer in Yokohama, Japan, October 15-18, 2017.
Wednesday, October 18th, 2017:
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10369
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Oral
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The Preclinical and Clinical Activity of Poziotinib, a Potent,
Selective Inhibitor of EGFR Exon 20 Mutant NSCLC
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Elamin, Heymach
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11:00 AM-11:10 AM JST
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Abstract #10369: The Preclinical and Clinical Activity of Poziotinib,
a Potent, Selective Inhibitor of EGFR Exon 20 Mutant NSCLC
Background
Approximately 10% of EGFR mutant NSCLCs have an insertion/mutation in
exon 20 of EGFR resulting in primary resistance to currently available
tyrosine kinase inhibitors (TKIs). We previously reported that the
structural features of poziotinib could potentially enable it to
circumvent the steric hindrance induced by exon 20 mutations. Here we
further characterize the preclinical activity of poziotinib and report
on initial clinical activity of poziotinib in patients EGFR exon 20
mutations from an ongoing phase II study.
Methods
We evaluated poziotinib activity in vitro using human NSCLC cell lines
and the BAF3 model as well as several patient-derived xenograft (PDX)
models and genetically engineered mouse models (GEMMs) of exon 20
insertion. We launched a phase 2 investigator-initiated trial of
poziotinib in patients with metastatic NSCLC with EGFR exon 20
insertions (NCT03066206).
Results: In vitro poziotinib was approximately 100x more potent
than osimertinib and 40x more potent than afatinib against a common
panel of EGFR exon 20 insertions. Furthermore, it had ~65-fold greater
potency against common exon 20 insertions compared with EGFR T790M
mutations; 3rd generation inhibitors osimertinib, EGF816, and
rociletinib were all significantly less potent for exon 20
mutations/insertions compared with T790M. in vivo poziotinib led to >85%
reduction in tumor burden in GEM models of EGFR exon 20 insertion
(D770insNPG) NSCLC and the PDX model LU0387 (H773insNPH).
To date, 8 platinum-refractory patients with EGFR exon 20 insertion
mutation metastatic NSCLC have been enrolled in the clinical trial and
treated with poziotinib at a dose of 16 mg PO daily. Two patients have
reached the first interval-imaging time point (at 8 weeks of therapy per
protocol). Both patients exhibited dramatic partial response, with one
patient reporting improvement in dyspnea and cough at one week of
therapy. In this early stage of the study, one case of grade 3
paronchycia was observed. One additional platinum- and
erlotinib-refractory patient with EGFR exon 20 insertion was treated
with poziotinib on compassionate basis. The patient achieved partial
response after three weeks of treatment.
Conclusion: Poziotinib has selective activity against EGFR exon
20 mutations and potent activity in cell lines, PDX, and GEM models.
Three platinum-refractory patients with EGFR exon 20 mutations have been
treated thus far and are evaluable for response; all three had partial
responses at the time of the initial scan. Updated data from the ongoing
phase 2 clinical trial of poziotinib will be presented at the meeting.
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. Spectrum
received exclusive license to develop, manufacture and commercialize
worldwide excluding Korea and China from Hanmi Pharmaceuticals.
About the WCLC
The World Conference on Lung Cancer (WCLC) is the world’s largest
meeting dedicated to lung cancer and other thoracic malignancies,
attracting over 6,000 researchers, physicians and specialists from more
than 100 countries. The goal is to disseminate the latest scientific
achievements; increase awareness, collaboration and understanding of
lung cancer; and to help participants implement the latest developments
across the globe. Organized under the theme of “Synergy to Conquer Lung
Cancer,” the conference will cover a wide range of disciplines and
unveil several research studies and clinical trial results. For more
information, visit http://wclc2017.iaslc.org/.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on
acquiring, developing, and commercializing drug products, with a primary
focus in Hematology and Oncology. Spectrum currently markets six
hematology/oncology drugs, and has an advanced stage pipeline that has
the potential to transform the Company. Spectrum's strong track record
for in-licensing and acquiring differentiated drugs, and expertise in
clinical development have generated a robust, diversified, and growing
pipeline of product candidates in advanced-stage Phase 2 and Phase 3
studies. More information on Spectrum is available at www.sppirx.com.
Forward-looking statement — 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
milestones, Spectrum's ability to identify, acquire, develop and
commercialize a broad and diverse pipeline of late-stage clinical and
commercial products, the timing and results of FDA decisions, and any
statements that relate to the intent, belief, plans or expectations of
Spectrum or its management, or that are not a statement of historical
fact.Risks that could cause actual results to differ include the
possibility that Spectrum’s existing and new drug candidates may not
prove safe or effective, the possibility that our existing and new
applications to the FDA and other regulatory agencies may not receive
approval in a timely manner or at all, the possibility that our existing
and new drug candidates, if approved, may not be more effective, safer
or more cost efficient than competing drugs, the possibility that our
efforts to acquire or in-license and develop additional drug candidates
may fail, our dependence on third parties for clinical trials,
manufacturing, distribution and quality control and other risks that are
described in further detail in the Company's reports filed with the
Securities and Exchange Commission.The Company does not 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.
SPECTRUM PHARMACEUTICALS, INC.® is a
registered trademarks of Spectrum Pharmaceuticals, Inc and its affiliate.REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are
trademarks owned by Spectrum Pharmaceuticals, Inc.Any other
trademarks are the property of their respective owners.
© 2017 Spectrum Pharmaceuticals, Inc.All Rights Reserved
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Contacts:
Spectrum Pharmaceuticals, Inc.
Shiv Kapoor
Vice President,
Strategic Planning & Investor Relations
702-835-6300
InvestorRelations@sppirx.com
Source: Spectrum Pharmaceuticals, Inc.
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