FDA agrees to the submission of an NDA for
poziotinib for non-small cell lung cancer (NSCLC) in previously
treated patients with HER2 exon 20 insertion mutations, NDA
submission planned for 2021
Cohort 3 of the ZENITH20 clinical trial, which
enrolled first-line NSCLC patients with EGFR exon 20 insertion
mutations at 16mg once daily, did not meet its primary endpoint
Preliminary data from 8 mg twice daily dosing
demonstrates meaningful improvement in tolerability
Management to host webcast and conference call
today at 4:30 p.m. ET / 1:30 p.m. PT
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a
biopharmaceutical company focused on novel and targeted oncology
therapies, today announced that the U.S. Food and Drug
Administration (FDA) has agreed to the submission of an NDA based
on data from Cohort 2 of its Phase 2 clinical trial, ZENITH20,
which evaluated previously treated patients with non-small cell
lung cancer (NSCLC) with HER2 exon 20 insertion mutations. The
company also reported that its pre-specified primary endpoint in
its Phase 2 clinical trial evaluating poziotinib in first-line
NSCLC patients with EGFR exon 20 insertion mutations was not met in
Cohort 3. Spectrum additionally reported that preliminary data from
patients receiving 8 mg of poziotinib twice daily demonstrated
meaningful improvement in tolerability as measured by adverse
events and dosing interruptions.
“The agreement with the FDA to proceed with the submission of a
new drug application is a significant milestone for the poziotinib
program,” said Joe Turgeon, President and CEO of Spectrum
Pharmaceuticals. “The improved tolerability from the BID dosing
could have a meaningful impact on the overall safety and efficacy
profile of poziotinib in an area of high unmet medical need.”
The company had a successful pre-NDA meeting with the FDA which
resulted in an agreement to submit an NDA for poziotinib. During
the meeting, Spectrum confirmed with the FDA that Cohort 2 data
could serve as the basis of an NDA submission. The company will
continue to work with the FDA as it prepares the application for
submission in 2021. Cohort 2 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% Confidence Interval (CI), 18.9%-38.2%). The observed
lower bound of 18.9% exceeded the pre-specified lower bound of 17%.
The median duration of response was 5.1 months and the median
progression free survival was 5.5 months. In this cohort, 87% of
patients had drug interruptions with 11 patients (12%) permanently
discontinuing due to adverse events. 13 patients (14%) had
treatment-related serious adverse events.
“We are pleased that the FDA meeting confirmed that Cohort 2
data can serve as the basis of a NDA submission and our team is
diligently working on preparing our file for submission in 2021,”
said Francois Lebel, M.D., Chief Medical Officer of Spectrum
Pharmaceuticals. “While Cohort 3 did not meet its pre-specified ORR
endpoint, we are seeing evidence of clinical activity with a
disease control rate (DCR) of 86% and progression free survival
data of 7.2 months.” Dr. Lebel added, “The preliminary data from
Cohort 5 with 8 mg twice daily dosing is supporting our hypothesis
that this new dosing paradigm improves tolerability substantially,
with Grade 3 adverse events reduced by about a third. We believe
that improved tolerability and reduced drug dosing interruptions
are key to patients staying on the drug longer and could
potentially enhance anti-tumor effectiveness across the various
EGFR and HER2 cohorts. These early findings, if confirmed, could
benefit the entire poziotinib program.”
Cohort 3 of the ZENITH20 clinical trial enrolled a total of 79
patients who received an oral once daily dose of 16 mg of
poziotinib. The median time of follow up of all patients was 9.2
months with 12 ongoing patients still on treatment. The
intent-to-treat analysis showed that 22 patients had a partial
response (by RECIST) and 68 patients had stable disease for an
86.1% DCR. 91% of patients experienced tumor reduction with a
median reduction of 25.5%. The confirmed ORR was 27.8% (95% CI
18.4-39.1%). Based on the pre-specified statistical hypothesis for
the primary endpoint, the observed lower bound of 18.4% did not
meet the pre-specified lower bound of >20%. The median duration
of response was 6.5 months and the median progression free survival
was 7.2 months. The safety profile was similar with the type of
adverse events observed with other second-generation EGFR tyrosine
kinase inhibitors. Grade 3 treatment related rash was 33% and
diarrhea was 23%. 94% of patients had drug interruptions with 6
patients (8%) permanently discontinuing due to adverse events.
Preliminary data from Cohort 5 for patients with exon 20
insertion mutations receiving 8 mg twice daily dosing shows
improved tolerability versus patients who received the 16 mg once
daily dose. The data from this cohort includes patients with both
EGFR and HER2 mutations. In Cycle 1, the incidence of Grade 3 or
higher treatment related adverse events (rash, diarrhea and
stomatitis) decreased by 32% for patients receiving the 8 mg twice
daily dose. In addition, dose interruptions were reduced by 38% for
the 8 mg twice daily dose versus the 16 mg once daily dose. No new
types of adverse events were observed with the twice daily dosing
regimen.
Conference Call and Webcast
The company’s management will host a webcast and conference call
today, December 22, 2020, at 4:30 p.m. ET / 1:30 p.m. PT. The live
call may be accessed by dialing (877) 837-3910 for domestic callers
and (973) 796-5077 for international callers and entering the
conference ID#: 5036836. A live webcast of the call will be
available from the Investor Relations section of the company’s
website at https://investor.sppirx.com/events-and-presentations and
will be archived there shortly after the live event.
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 ZENITH20
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.
In September 2020, the company reported that Cohort 2 met its
primary endpoint. Cohorts 4 - 7 are still enrolling patients.
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 3’s reported results; the significance of the preliminary
data from Cohort 5, including, but not limited to, whether the new
dosing paradigm will continue to improve tolerability, lead to
patients staying on the drug longer and enhance anti-tumor
effectiveness and the impact of such data on the entire poziotinib
program; the timing and outcome of filing an NDA with Cohort 2 data
with the FDA; the overall determination of a path forward for
poziotinib; poziotinib’s potential to significantly advance the
treatment of NSCLC patients with EGFR or HER2 exon 20 insertion
mutations; the timing and result of future FDA approvals; 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
potential of the company’s existing drug pipeline 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 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, including the NDA with Cohort 2 data it plans to submit
in 2021, 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 (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 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.® and ROLONTIS® are registered
trademarks of Spectrum Pharmaceuticals, Inc. and its affiliates.
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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version on businesswire.com: https://www.businesswire.com/news/home/20201222005627/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
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