Spectrum Pharmaceuticals Expands Poziotinib Clinical Trial Into First-Line Therapy and Doses First Patient
September 12 2018 - 7:00AM
Business Wire
- Spectrum’s Phase 2 non-small cell lung
cancer (NSCLC) study expanded to include two new cohorts for
first-line NSCLC patients with EGFR or HER2 exon 20 insertion
mutations
- Phase 2 study now includes four cohorts
with each cohort being an independent study with pre-specified
statistical hypotheses and statistical power
- First patient has been dosed in this
expanded patient population
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology
company with fully integrated commercial and drug development
operations with a primary focus in hematology and oncology, today
announced that it has initiated two new cohorts for first-line,
locally advanced or metastatic non-small cell lung cancer (NSCLC)
patients with EGFR or HER2 exon 20 insertion mutations in its
current Phase 2 non-small cell lung cancer (NSCLC) clinical trial.
Spectrum also announced that it has dosed the first patient in the
expanded patient population.
“Given the exciting preliminary poziotinib clinical
data in NSCLC patients with EGFR exon 20 mutations who have
received prior systemic therapy, we are happy to extend our
participation in Spectrum’s trial to explore
poziotinib's activity in the first-line setting,” said
Jonathan Goldman, M.D., Associate Professor of Hematology and
Oncology, Associate Director of Drug Development and Director of
Clinical Trials in Thoracic Oncology at UCLA Health. "Current
available therapies for NSCLC patients with exon 20 insertion
mutations have been shown to be minimally effective. We do not have
good options for these patients as we do in other settings with
actionable mutations. This clinical trial expansion is a welcome
milestone for patients and physicians battling this disease.”
The poziotinib NSCLC clinical program for patients with EGFR or
HER2 exon 20 mutations currently consists of a Phase 2 pivotal,
Spectrum-sponsored, multi-center global study (ZENITH20) with
active sites in the United States and future centers planned in
Canada and Europe, and a Phase 2 investigator-initiated study at
the University of Texas MD Anderson Cancer Center. Spectrum’s
ZENITH20 study now includes four cohorts, with each cohort being an
independent study with pre-specified statistical hypotheses and
statistical power. The protocol amendment incorporating the two new
cohorts was designed based on input from the FDA. The two
previously-treated cohorts will enroll up to 87 patients each, and
the two first-line cohorts will enroll up to 70 patients each. For
each cohort, the primary endpoint is objective response rate; the
secondary endpoints are disease control rate, duration of response,
safety and tolerability; and the exploratory endpoints are
progression-free survival and quality of life.
About Poziotinib
Poziotinib is a novel, orally administered Epidermal Growth
Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) that inhibits
the tyrosine kinase activity of EGFR (HER1) as well as HER2 and
HER4. Importantly, this 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 an exclusive license to develop,
manufacture, and commercialize worldwide excluding Korea and China
from Hanmi Pharmaceuticals.
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.
© 2018 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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