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.
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 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."
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.
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20171017006868/en/
Spectrum Pharmaceuticals, Inc.
Strategic Planning & Investor Relations
Source: Spectrum Pharmaceuticals, Inc.
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