- Poziotinib demonstrates evidence of
significant antitumor activity in NSCLC patients with EGFR exon 20
insertion mutations, with interim data showing an Objective
Response Rate of 73%.
- Evidence of central nervous system
(CNS) activity in a patient with CNS metastasis and another with
leptomeningeal disease (LMD).
- On October 18th at 8:30
a.m. EDT/5:30 a.m. PDT, the Company will hold a conference
call with Dr. John Heymach, from The University of Texas MD
Anderson Cancer Center to discuss the study results.
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 oral presentation of interim data from a Phase 2
clinical study evaluating poziotinib in EGFR Exon 20 Mutant
Non-Small-Cell Lung Cancer (NSCLC) by scientists from the MD
Anderson Cancer Center which was presented in Yokohama,
Japan, October 15-18, 2017. The Company will hold a conference
call tomorrow, October 18th, at 8:30 a.m. EDT/5:30 a.m.
PDT with Dr. 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,
to discuss his study results.
“These data are remarkable for NSCLC patients with exon 20
insertion mutations,” said John Heymach, M.D., Ph.D., The
University of Texas MD Anderson Cancer Center. “These patients
currently have a poor prognosis, single-digit response rate on
first generation tyrosine kinase inhibitors (TKI’s), and a PFS of
about two months. What is truly noteworthy is that all 11 study
patients who received poziotinib at a 16mg daily dose and have
reached their first scan, have seen some level of tumor shrinkage.
Interestingly, we have also seen evidence of CNS activity.
Toxicities have included rash, diarrhea, paronychia, and mucositis
consistent with those previously described for poziotinib and other
TKI’s, which led to dose reduction in 55% of the patients. We
believe that poziotinib specifically inhibits EGFR with exon 20
insertion mutations because it overcomes steric hindrance caused by
exon 20 insertions, due to its smaller size and flexibility. To
date poziotinib has shown promising results in patients with exon
20 insertion mutations and we are fortunate to be leading the
efforts in the continuing development of this product.”
“We are greatly encouraged with the clinical data emerging from
poziotinib and plan to pursue its clinical development
expeditiously and aggressively,” said Rajesh C. Shrotriya,
M.D., Chairman and Chief Executive Officer of Spectrum
Pharmaceuticals. “In the near future, we plan to discuss the
regulatory pathway for poziotinib with the FDA. At the same time,
we are embarking upon an overall strategy for global clinical
development and regulatory filings. With three promising drugs in
late-stage development, Spectrum’s pipeline has never been as
exciting and our prospects never as bright.”
Conference Call
Wednesday, October 18,
2017 @ 8:30 a.m. Eastern/5:30
a.m. Pacific
Domestic: (877) 837-3910, Conference ID#
86093351
International: (973) 796-5077, Conference ID#
86093351
For interested individuals unable to join the call, a replay
will be available from October 18, 2017 @ 11:30 a.m.
ET/8:30 a.m. PT through October 28, 2017,
until 11:30 a.m. ET/8:30 a.m. PT.
Domestic Replay Dial-In #: (855) 859-2056,
Conference ID# 86093351
International Replay Dial-In #: (404)
537-3406, Conference ID# 86093351
This conference call will also be webcast. Listeners may access
the webcast, which will be available on the investor relations page
of Spectrum
Pharmaceuticals' website: www.sppirx.com on October
18, 2017, at 8:30 a.m. Eastern/5:30
a.m. Pacific.
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. Poziotinib is currently being
investigated by Spectrum and Hanmi in several mid-stage trials in
multiple solid tumor indications.
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 covers a wide range of disciplines and unveils 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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version on businesswire.com: http://www.businesswire.com/news/home/20171017006868/en/
Spectrum Pharmaceuticals, Inc.Shiv KapoorVice President,
Strategic Planning & Investor Relations(702)
835-6300InvestorRelations@sppirx.com
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