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:
Abstract # Type
Title First Author/Presenting Author
Time 10369 Oral The Preclinical and
Clinical Activity of Poziotinib, a Potent, Selective Inhibitor of
EGFR Exon 20 Mutant NSCLC Elamin, Heymach 11:00 AM-11:10 AM JST
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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Spectrum Pharmaceuticals, Inc.Shiv KapoorVice President,
Strategic Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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