Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical
company focused on novel and targeted oncology therapies, today
presented results from Cohort 3 and initial twice daily (BID)
dosing safety and efficacy data for poziotinib from Cohort 5 of the
ZENITH20 clinical trial. These preliminary data demonstrate
improved tolerability with BID dosing, reduced dose interruption
compared to once daily (QD) dosing, and a reduction in treatment
emergent Grade 3 or higher adverse events. The preliminary data
also suggest improved anti-tumor activity with 8mg BID dosing. The
presentation is part of the European Society for Medical Oncology
Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021
being held March 1-2, 2021.
“As predicted by the pharmacokinetic modeling, the 8mg BID arm
is showing an improved therapeutic effect and a lowered adverse
event rate in this early data,” said Francois Lebel, M.D., Chief
Medical Officer of Spectrum Pharmaceuticals. “The data build on the
positive results we have reported for Cohort 2 which will be the
basis for our NDA submission later this year. We look forward to
reporting additional data at AACR in April.”
A copy of the ESMO presentation titled “Safety, tolerability and
preliminary efficacy of poziotinib with twice daily strategy in
EGFR/HER2 Exon 20 mutant non-small cell lung cancer” is available
on Spectrum’s website at
https://investor.sppirx.com/events-and-presentations.
ZENITH20 Trial Design and Preliminary Safety and Efficacy
Data for Cohort 5
Cohort 5 of the ZENITH20 trial includes previously treated NSCLC
patients with EGFR or HER2 exon 20 insertion mutations. This cohort
is investigating the efficacy of poziotinib with a BID dosing
strategy. For the first 20 patients randomized to poziotinib 16 mg
QD or 8 mg BID in Cohort 5, a trend towards improved responses was
reported in the BID arm with 30% of patients reaching a partial
response and two patients still too early to evaluate.
Preliminary Data on Best Overall
Response
Cohort 1
Cohort 5a
Cohort 5d
16mg QD
16mg QD
8mg BID
N=10 (%)
N=10 (%)
N=10 (%)
PR - Partial Response
2 (20)
2 (20)
3 (30)
SD - Stable Disease
5 (50)
4 (40)
2 (20)
PD - Progressive Disease
2 (20)
0
1 (10)
NE - Not Evaluable (withdrawn)
1 (10)
4 (40)
2 (20)
NA - Too Early to Assess
0
0
2 (20)
Improved tolerability was also observed, with a greater than 30%
reduction in Grade 3 or higher adverse events for the BID arms
relative to QD. In addition, there were 23% fewer dose
interruptions for 8mg BID vs 16mg QD and 43% fewer dose
interruptions for 6mg BID vs 12mg QD.
BID Dosing Exposure and Safety
Preliminary Data (study
enrolling)
16mg QD
8mg BID
12mg QD
6mg BID
Enrolled
22
16
23
16
Drug Interruption, n (%)
18 (82)
10 (63)
20 (87)
8 (50)
Dose Reduction
13 (59)
8 (50)
13 (57)
6 (38)
Treatment Related AE ≥ Grade 3
10 (45)
5 (31)
9 (39)
3 (19)
While preliminary, these data support the hypothesis that BID
dosing could improve the therapeutic effect for patients receiving
poziotinib and result in better outcomes. Cohort 5 is continuing to
enroll patients and a presentation of additional results is
expected later this year at a medical conference.
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
Spectrum’s business and its future, including the significance of
the preliminary dosing data for poziotinib, including the ability
to achieve an improved therapeutic effect and a lowered adverse
event rate with BID dosing; the company’s plans to present
additional study results at a medical conference later in the year;
poziotinib’s potential to significantly advance the treatment of
NSCLC patients with EGFR or HER2 exon 20 insertion mutations; the
timing and results of the company’s planned NDA submission; the
overall progression of the poziotinib development program; the
company’s ability to advance and fund the development and
commercialization 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 its ability to
transform the company in the near future; 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
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; other uncertainties inherent in new product
development; 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 “SEC”). 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, 2019, and in
subsequent reports on Forms 10-K, 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.
© 2021 Spectrum Pharmaceuticals, Inc. All Rights Reserved
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210302005921/en/
Robert Uhl Managing Director, Westwicke ICR 858.356.5932
robert.uhl@westwicke.com
Kurt Gustafson Chief Financial Officer 949.788.6700
InvestorRelations@sppirx.com
Spectrum Pharmaceuticals (NASDAQ:SPPI)
Historical Stock Chart
From Aug 2024 to Sep 2024
Spectrum Pharmaceuticals (NASDAQ:SPPI)
Historical Stock Chart
From Sep 2023 to Sep 2024