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Results are expected in the second half of 2019
HENDERSON, Nev.--(BUSINESS WIRE)--Jan. 2, 2019--
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 full
enrollment of cohort 1 (N=87) for previously treated Non-Small Cell Lung
Cancer (NSCLC) patients with EGFR exon 20 insertion mutations with sites
across the U.S., Europe, and Canada. The EGFR previously treated cohort
is part of the ZENITH20 trial – an open-label, multi-center, global
Phase 2 trial evaluating NSCLC patients with EGFR or HER2 exon 20
insertion mutations. Results from this cohort are expected by the second
half of 2019.
“The rapid rate at which we enrolled our Phase 2 previously treated EGFR
exon 20 insertion mutations cohort speaks to the critical unmet medical
need and demonstrates that the poziotinib program is aggressively
advancing,” said Joe Turgeon, President and Chief Executive Officer
of Spectrum Pharmaceuticals. “We are pleased with the results seen in
smaller poziotinib trials and look forward to data from this larger,
multi-center trial in the second half of the year.”
The EGFR previously treated cohort is the first to fully enroll in the
ZENITH20 trial. This study consists of four cohorts, each of which is
independently powered for a pre-specified statistical hypothesis. There
are two cohorts in the previously-treated NSCLC setting and two in the
first-line setting. The primary endpoint is objective response rate
(ORR). Additional endpoints include duration of response (DOR), disease
control rate (DCR), progression-free survival (PFS) and safety.
“Full enrollment of the first cohort marks an important milestone as
this cohort is intended to provide the data required for the NDA
filing,” said Francois Lebel, M.D., F.R.C.P.C, Chief Medical Officer
of Spectrum Pharmaceuticals. “Our poziotinib development program is
investigating the treatment of exon 20 mutations across tumor types as
these mutations are among the most difficult-to-treat and currently have
no targeted FDA-approved therapies, leaving patients and physicians with
very limited options.”
About Poziotinib
Poziotinib is a novel, oral Epidermal Growth Factor Receptor Tyrosine
Kinase Inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity
of EGFR 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. The full poziotinib targeted therapy clinical program is focused
on four development areas for EGFR and HER2 mutations, including
previously treated NSCLC, first-line NSCLC, treatment of other solid
tumors and combination therapy.
Spectrum received exclusive license from Hanmi Pharmaceuticals to
develop, manufacture, and commercialize poziotinib worldwide,
excluding Korea and China. Poziotinib is currently being investigated by
Spectrum and Hanmi in several trials in multiple solid tumors.
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 seven
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 Statements
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.
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.
© 2019 Spectrum Pharmaceuticals, Inc. All Rights Reserved
View source version on businesswire.com: https://www.businesswire.com/news/home/20190102005095/en/
Source: Spectrum Pharmaceuticals, Inc.
Shiv Kapoor
Vice President, Strategic Planning & Investor Relations
702-835-6300
InvestorRelations@sppirx.com
