Spectrum Pharmaceuticals Announces Initiation of a Multicenter Phase 2 Trial of Poziotinib in Non-Small Cell Lung Cancer (NSC...
October 30 2017 - 7:00AM
Business Wire
- The study will evaluate Objective
Response Rate (ORR) as the primary endpoint.
- 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.
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 evaluated.
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.Shiv KapoorVice President,
Strategic Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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