Spectrum Pharmaceuticals Presents Results in HER2 Exon 20 Insertion Mutations from Cohort 2 of the Poziotinib ZENITH20 Clinic...
September 18 2020 - 7:00AM
Business Wire
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical
company focused on novel and targeted oncology therapies, today
presented additional results from its pivotal Phase 2 clinical
trial, ZENITH20, evaluating poziotinib in previously treated
non-small cell lung cancer (NSCLC) patients with HER2 exon 20
insertion mutations (Cohort 2). The on-demand mini oral session is
part of the European Society for Medical Oncology (ESMO) Virtual
Congress 2020 Science Weekend being held September 19 – 21,
2020.
“This is the first presentation to the medical and scientific
community of the positive results from our registrational Cohort 2
from the ZENITH20 clinical trial,” said Francois Lebel, M.D., Chief
Medical Officer of Spectrum Pharmaceuticals. “There is no approved
treatment for NSCLC patients with HER2 exon 20 insertion mutations,
and we look forward to sharing this data with the FDA and
discussing the path forward for poziotinib registration.”
The presentation titled “ZENITH20, a multinational, multi-cohort
Phase 2 study of poziotinib in NSCLC patients with EGFR or HER2
Exon 20 mutations” is available to members of ESMO and can be
accessed on the meeting website here:
https://cslide.ctimeetingtech.com/esmo2020/attendee/confcal_1/session/list?q=poziotinib&r=st%7E12.
A copy of the slides can also be found at:
https://investor.sppirx.com/index.php/events-and-presentations.
ZENITH20 Trial Design and Results for Cohort 2
Cohort 2 of the ZENITH20 trial enrolled 90 patients who received
an oral once daily dose of 16 mg of poziotinib. The intent-to-treat
analysis demonstrated a confirmed objective response rate (ORR) of
27.8% (95% CI, 18.9%-38.2%). The observed lower bound of 18.9%
exceeded the pre-specified lower bound of 17%. The disease control
rate (DCR) was 70% while tumor reduction occurred in 67 patients
(74%), with median tumor reduction of 22%. The evaluable patient
analysis (n=74) demonstrated a confirmed ORR of 35.1% (95% CI,
24.4% – 47.1%) with a disease control rate of 82.4%.
The median duration of response was 5.1 months (range 1 to
>12.3), with a median follow up of 8.3 months and the median
progression free survival was 5.5 months (range 0 to >13.1). 13
patients (14%) had treatment-related serious adverse events and 11
patients (12%) permanently discontinued due to adverse events.
Grade 3 treatment related rash was observed in 27 patients (30%)
with diarrhea in 23 patients (26%). Stomatitis/mucosal inflammation
Grades 3 and 4 occurred in 21 patients (23%). Dose interruptions
were reported in 78 patients (87%), and dose reductions in 70
patients (78%), which was similar to the rates in Cohort 1.
Cohort 2 was designed to be a registrational study. Based on
these results, Spectrum has requested a meeting with the U.S. Food
and Drug Administration (FDA) to discuss the data and its plans for
a New Drug Application (NDA) submission.
The ZENITH20 trial is comprised of 7 independent cohorts.
Cohorts 1 - 4 are each independently powered for a pre-specified
statistical hypothesis with a primary endpoint of ORR. Cohorts 5 -
7 are exploratory. In December 2019, the company reported that the
primary endpoint for Cohort 1 (EGFR) was not met but clinical
activity was seen. Based on the results of Cohort 1, the company
has amended the protocol for ZENITH20 to explore additional
twice-daily dosing regimens as well as lower single daily dosage.
This amendment did not impact Cohorts 2 and 3 as these cohorts were
fully enrolled. Top line results from Cohort 3 are expected by the
end of the year.
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,
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. The
company holds an exclusive license from Hanmi Pharmaceuticals to
develop, manufacture, and commercialize poziotinib worldwide,
excluding Korea and China. Poziotinib is currently being
investigated by the company and Hanmi in several mid-stage trials
in multiple solid tumor indications.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biopharmaceutical company focused
on acquiring, developing, and commercializing novel and targeted
oncology therapies. 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. For additional information on
Spectrum Pharmaceuticals, please visit www.sppirx.com.
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
the company’s business and its future, including the significance
of Cohort 2’s reported results; the timing and outcome of a
potential meeting with the FDA regarding poziotinib and the FDA’s
determination of a path forward for poziotinib; poziotinib’s
potential to significantly advance the treatment of NSCLC patients
with HER2 exon 20 insertion mutations; the timing and result of
future FDA approvals; the timing of the results of Cohort 3; the
overall progression of the poziotinib development program; the
company’s ability to advance development of its late-stage pipeline
assets and such assets’ ability to serve areas of unmet need; the
future potential of the company’s existing drug pipeline; 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 the
company 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 the possibility
that the different methodologies, assumptions and applications the
company utilizes to assess particular safety or efficacy parameters
may yield different statistical results, and even if the company
believes the data collected from the clinical trials of its product
candidates, including poziotinib, are positive, these data may not
be sufficient to support approval by the FDA; the possibility that
success in early clinical trials, especially if based on a small
patient sample, might not result in success in later clinical
trials, and other unforeseen events during clinical trials which
could cause delays or other adverse consequences; the company’s
existing and new drug candidates, including poziotinib, may not
prove safe or effective; the possibility that the company’s
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 the company’s existing and new drug candidates,
including poziotinib, if approved, may not be more effective, safer
or more cost efficient than competing drugs; the possibility that
the company’s efforts to acquire or in-license and develop
additional drug candidates may fail; the company’s 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. 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 the company in general, see the risk
disclosures in the company’s Annual Report on Form 10-K for the
year ended December 31, 2019, and in subsequent reports on Forms
10-Q and 8-K and other filings made with the SEC by the
company.
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.
© 2020 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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Robert Uhl Managing Director, Westwicke ICR 858.356.5932
robert.uhl@westwicke.com
Kurt Gustafson Chief Financial Officer 949.788.6700
InvestorRelations@sppirx.com
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