Spectrum Pharmaceuticals Expands Poziotinib Clinical Trial Into First-Line Therapy and Doses First Patient

  • 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

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, 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

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.
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.

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


Spectrum Pharmaceuticals, Inc.
Shiv Kapoor
Vice President,
Strategic Planning & Investor Relations

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