Publication highlights pre-clinical and
clinical activity of poziotinib in lung cancer patients with HER2
mutations and potential future applications using monotherapy and
combinations in many different mutated cancers
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a
biopharmaceutical company focused on novel and targeted oncology
therapies, announced today a publication from The University of
Texas, MD Anderson Cancer Center entitled, “Pan-Cancer Landscape
and Functional Analysis of ERBB2 Mutations Identifies Poziotinib as
a Clinically Active Inhibitor and Enhancer of T-DM1 Activity.” The
publication appears in the Oct 3, 2019 online issue at
https://www.cell.com/cancer-cell/fulltext/S1535-6108(19)30384-8 and
will be published in a future print issue of Cancer Cell.
“Our analysis is the largest ever conducted to understand the
diversity of HER2 mutations across 25 cancer types, including more
than 200,000 patients from cBioPortal, MD Anderson, Foundation
Medicine, and Guardant Health,” said John Heymach, M.D., Ph.D.,
Chairman and Professor, Department of Thoracic/Head and Neck
Medical Oncology at MD Anderson. “In our pre-clinical study of 11
EGFR/HER2 tyrosine kinase inhibitors, poziotinib was the most
potent HER2 mutant-selective TKI tested, and in our initial
clinical cohort we found that poziotinib was highly active in NSCLC
patients with HER2 exon 20 mutations. Our findings indicate that
poziotinib may be well-suited to target HER2 mutations with a
constricted binding pocket. Furthermore, we have determined from
pre-clinical data that poziotinib is synergistic with a
HER2-targeting antibody-drug conjugate, providing a rationale for
combinations to move forward into the clinic.”
Spectrum is studying poziotinib in ZENITH20, a
company-sponsored, open-label, single-arm, multi-center, global
Phase 2 study of non-small cell lung cancer (NSCLC) patients.
“The publication of these latest research findings from MD
Anderson on poziotinib in the journal Cancer Cell continues to
strengthen the evidence of the potential benefit of poziotinib in
the treatment of lung cancer,” said Joe Turgeon, President and CEO,
Spectrum Pharmaceuticals. “This quarter, we plan to disclose
topline data from the first cohort of the company-sponsored
ZENITH20 study, which is analyzing previously-treated NSCLC
patients with exon 20 mutations in EGFR. By mid-2020 we also expect
topline data from cohort 2, which is studying previously treated
NSCLC patients with exon 20 mutations in HER2. We look forward to
the top line data from the ZENITH20 study this quarter and continue
to expand the poziotinib program, based on emerging science, to
other areas of opportunity.”
About Poziotinib
Poziotinib is a novel, oral 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 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 ZENITH20
The ZENITH20 study consists of seven cohorts of NSCLC patients.
Cohorts 1 (EGFR) and 2 (HER2) have completed enrollment of
previously-treated NSCLC patients with exon 20 mutations. Cohort 3
(EGFR) and 4 (HER2) are currently enrolling first-line NSCLC
patients with exon 20 mutations. Cohorts 1- 4 are each
independently powered for a pre-specified statistical hypothesis
and the primary endpoint is objective response rate (ORR). In July
2019, three new cohorts were added to the ZENITH20 study that are
all currently enrolling patients. Cohort 5 includes previously
treated or treatment-naïve NSCLC patients with EGFR or HER2 exon 20
insertion mutations. Cohort 6 includes NSCLC patients with
classical EGFR mutations who progressed while on treatment with
first-line osimertinib and developed an additional EGFR mutation.
Cohort 7 includes NSCLC patients with a variety of less common
mutations in EGFR or HER2 exons 18-21 or the extracellular or
transmembrane domains.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biopharmaceutical company focused
on acquiring, developing, and commercializing novel and targeted
drug products, with a primary focus in hematology and oncology.
Spectrum has a strong track record of successfully executing across
the biopharmaceutical business model, from in-licensing and
acquiring differentiated drugs, clinically developing novel assets,
successfully gaining regulatory approvals and commercializing in a
competitive healthcare marketplace. Spectrum has a late-stage
pipeline with novel assets that serve areas of unmet need. This
pipeline has the potential to transform the company in the near
future.
Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute
“forward-looking statements” within the meaning of the United
States Private Securities Litigation Reform Act of 1995, as amended
to date. These forward-looking statements relate to a variety of
matters, including, without limitation, statements that relate to
Spectrum’s business and its future, including the Company’s ability
to advance development of its late-stage pipeline assets, the
ability of poziotinib to meet currently unaddressed medical needs
and the size of the potential markets, the timing of the results of
cohort 1 and cohort 2 in Spectrum’s ZENITH20 study, the future
potential of Spectrum’s existing drug pipeline, the progression of
the poziotinib development program and other statements that are
not purely statements of historical fact. These forward-looking
statements are made on the basis of the current beliefs,
expectations, and assumptions of the management of Spectrum and are
subject to significant risks and uncertainties that could cause
actual results to differ materially from what may be expressed or
implied in these forward-looking statements. Risks that could cause
actual results to differ include, but are not limited to, the
uncertainties inherent in new product development, including
clinical trial results and additional analysis of existing
pre-clinical and clinical data, the possibility that Spectrum's new
and existing drug candidates, including poziotinib, may not
ultimately prove to be safe or effective, the possibility that
Spectrum's new and existing drug candidates, if approved, may not
be more effective, safer, or more cost efficient than competing
drugs, 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. For a further discussion of risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to the business of Spectrum in general, see the risk
disclosures in the Annual Report on Form 10-K of Spectrum for the
year ended December 31, 2018, and in subsequent reports on Forms
10-Q and 8-K and other filings made with the SEC by Spectrum.
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
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Relations 702-835-6300 InvestorRelations@sppirx.com
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