The study will evaluate Objective Response Rate (ORR) as the
Objective Response Rate of 73% was observed in preliminary analysis
of an ongoing Phase 2 study being conducted by Dr. John Heymach at the
University of Texas MD Anderson Cancer Center. These data were
presented earlier this month in Japan at the 18th IASLC World
Conference on Lung Cancer.
Spectrum has worldwide rights to poziotinib,
excluding Korea and China.
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 today the initiation
of a Phase 2 trial evaluating poziotinib in non-small cell lung cancer
patients with an exon 20 insertion mutation in EGFR or HER2. The first
patient has been enrolled and the Company expects to enroll patients at
several leading cancer institutions in the United States.
"Following the promising preliminary data from the University of Texas
MD Anderson Cancer Center's study, we are excited to launch this
multicenter trial," said Rajesh C. Shrotriya, MD, Chairman and Chief
Executive Officer of Spectrum Pharmaceuticals. "Earlier this month,
results presented at the 18th IASLC World Conference on Lung Cancer
showed that poziotinib has the potential to address unmet needs of lung
cancer patients with EGFR Exon 20 insertion mutations. The efficacy of
first-generation tyrosine-kinase inhibitors has been found to be
unsatisfactory in such patients, resulting in single digit response
rates and a progression-free survival of around two months. We are
grateful for the guidance the Food and Drug Administration has provided
in designing this trial."
The goal of this Phase 2 trial is to evaluate both the efficacy and
safety of poziotinib in patients with non-small cell lung cancer (NSCLC)
that is locally advanced or metastatic and have an exon 20 insertion
mutation in either EGFR or HER2. This trial will enroll up to 87
patients with EGFR exon 20 insertion mutations and up to 87 patients
with HER2 exon 20 insertion mutations in several leading cancer
institutions. The study will evaluate objective response rate (ORR) as
the primary endpoint, and disease control rate (DCR), duration of
response (DOR), and safety as secondary endpoints. In addition,
progression-free survival (PFS) and quality of life (QoL) will be
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.
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 Pharmaceuticals, Inc.
Strategic Planning & Investor Relations
Source: Spectrum Pharmaceuticals, Inc.
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