Spectrum Pharmaceuticals Announces Initiation of a Phase 2 Trial of Poziotinib in Non-Small Cell Lung Cancer Patients with EG...
March 30 2017 - 7:00AM
Business Wire
- Encouraging results observed in patient
with exon 20 insertion mutation treated with poziotinib on a
compassionate basis.
- Phase 2 trial will evaluate Objective
Response Rate (ORR) as the primary endpoint.
- Top-line results are expected before
year-end.
- Spectrum has worldwide rights to
poziotinib, excluding Korea and China.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology
company with fully integrated commercial and drug development
operations with a primary focus in Hematology and Oncology, today
announced that the University of Texas MD Anderson Cancer Center
initiated a Phase 2 trial of poziotinib in non-small cell lung
cancer patients with EGFR exon 20 insertion mutations. This Phase 2
trial will evaluate Objective Response Rate (ORR) as the primary
endpoint and is expected to yield preliminary results before
year-end.
“We are excited to be collaborating with a prominent institution
to continue to develop our potential best-in-class, novel, pan-HER
inhibitor, poziotinib,” said Rajesh C. Shrotriya, M.D., Chairman
and Chief Executive Officer of Spectrum Pharmaceuticals. “Tumors
with exon 20 mutations have generally not been responsive to
several other EGFR inhibitors. However, poziotinib, due to its
unique structure and characteristics, is hypothesized to inhibit
cell growth of EGFR exon 20 insertions. Preclinical results from
poziotinib are very encouraging, and poziotinib has the potential
to be a transforming therapy for these patients who have few or no
options and poor prognosis. We look forward to working closely with
MD Anderson Cancer Center on this study.”
“Patients who suffer from this rare cancer have very few options
for treatment and a poor prognosis with median progression free
survival (PFS) of less than 2 months,” said John Heymach,
M.D., Ph.D., Chairman, Professor, and David Bruton
Junior Chair in Cancer Research, Department of
Thoracic/Head and Neck Medical Oncology, The University of
Texas MD Anderson Cancer Center. “Recently we saw promising
preclinical results from poziotinib and based on our preclinical
studies, drug screening, and computational modeling, we
believe that poziotinib could potentially overcome steric
hindrance of the drug binding pocket induced by the exon 20
insertion mutations. We have already seen encouraging results
in a patient with this mutation who was recently treated with
poziotinib on a compassionate basis. We look forward to
further results from this trial later this year.”
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. Currently, poziotinib is being investigated by
Hanmi in several mid-stage trials in different solid tumor
indications including HER2-positive breast cancer. (Phase 2
sponsored by National OncoVenture, a funding initiative by the
Korean government's National Cancer Center).
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 trademark 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 PharmaceuticalsShiv KapoorVice President, Strategic
Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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