- The abstract reported new interim data
from the EGFR cohort and, for the first time, the HER2 cohort in
the MD Anderson Phase 2 trial
- In the EGFR cohort, an objective
response rate of 58% and a disease control rate of 90% were
reported
- In the HER2 cohort, an objective
response rate of 50% and a disease control rate of 83% were
reported
- Updated data will be presented in an
oral session at the conference on September 24
- Spectrum will host a live webcast
following the oral presentation
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 new interim poziotinib data from the MD Anderson Phase 2
non-small cell lung cancer (NSCLC) study which appeared in an
online abstract as part of the IASLC 19th World Conference on Lung
Cancer hosted by the International Association for the Study of
Lung Cancer. The interim results, which include data from the EGFR
cohort and, for the first time, the HER2 cohort, are preliminary
and based on data through May 3, 2018. More robust and updated data
will be presented in an oral session on September 24 at the
conference in Toronto, Canada.
“These results add to a growing body of evidence supporting the
role of poziotinib in patients with EGFR and HER2 exon 20
mutations, and are a real advance for these patients for whom no
targeted therapies have been effective so far,” said John Heymach,
M.D., Ph.D., Chairman and Professor, Department of Thoracic/Head
and Neck Medical Oncology, University of Texas, MD Anderson Cancer
Center. “I am highly encouraged by these results and the evolution
of poziotinib data. Our study is the single largest data set in
this high unmet need patient population and I am excited to present
updated data during an oral session at the IASLC World Conference
on Lung Cancer.”
Data appearing in the abstract were current as of May 3, 2018.
40 patients of the 50 patient EGFR cohort had data available for
the efficacy analysis. In the 40 patients, poziotinib continued to
show robust efficacy with an objective response rate (ORR) of 58%
in this heavily pre-treated population. Median progression free
survival (PFS) was 5.6 months (95%-CI 5.06-NA). The disease control
rate was 90%. In the HER2 cohort the ORR was 50% and the disease
control rate was 83%. The most common adverse events were skin-rash
(27.5%), diarrhea (12.5%), and paronychia (7.5%). 45.0% of patients
required dose reduction to 12mg, while 17.5% of patients required
dose reduction to 8mg. Updated data will be presented at the
conference and will include data into September.
“We are thrilled with the data presented in the abstract and
look forward to a more robust data set on September 24th,” said Joe
Turgeon, President and CEO of Spectrum Pharmaceuticals.
“Additionally, we believe the treatment potential of poziotinib may
go well beyond the previously treated lung cancer setting. We are
actively expanding the poziotinib clinical program to explore
poziotinib in new areas including first-line treatment of NSCLC,
treatment of other solid tumors with EGFR or HER2 mutations, and
combination therapies.”
Spectrum Pharmaceuticals will be hosting a live webcast on
September 24 following the oral presentation.
Abstract: A Phase II Trial of Poziotinib in EGFR and HER2
exon 20 Mutant Non-Small Cell Lung Cancer
Background
Insertions/mutations in exon 20 of EGFR and HER2 occur in ~1%
and ~3% of all lung adenocarcinomas, respectively. These
alterations are characterized by primary resistance to approved
tyrosine kinase inhibitors (TKIs) with response rates of <12%.
We have previously shown that exon 20 insertions restrict the size
of the drug-binding pocket, limiting binding of large inhibitors.
However, poziotinib can circumvent these steric changes and is a
potent inhibitor of EGFR and HER2 exon 20 mutants (Robichaux et al.
Nat Med). Herein, we report the results of an
investigator-initiated study of poziotinib in EGFR and HER2 exon 20
mutant NSCLC (NCT03066206).
Methods
Patients ≥18yrs with locally advanced/metastatic NSCLC bearing
mutations/insertions in EGFR or HER2 exon 20 (except EGFR T790M)
were eligible. Unlimited prior systemic and targeted therapies were
permitted. Poziotinib 16mg PO daily was administered until
progression, death, or withdrawal. The primary endpoint was
objective response rate (ORR) based on RECIST v1.1. Response was
evaluated every eight weeks. A Bayesian design was used with a plan
to enroll patients in cohorts of 10 and to terminate the study if
ORR was ≤20%. Secondary endpoints included disease control rate
(DCR); progression-free survival (PFS); overall survival; and
safety.
Results
As of May 3, 2018, the planned EGFR cohort of 50 patients was
fully enrolled, and 40 patients were evaluated for response. Median
age was 55yrs (range 29-78). 65.1% of patients had received at
least two prior lines of therapy for metastatic disease. 60% of
patients had ≥grade 3 adverse events; most common were skin-rash
(27.5%), diarrhea (12.5%), and paronychia (7.5%). 45.0% of patients
required dose reduction to 12mg, while 17.5% of patients required
dose reduction to 8mg. One patient stopped the treatment due to
grade 3 skin rash. The ORR at eight weeks was 58% (95%-CI
40.9-73.0) and the DCR was 90% (95%-CI 76.3-97.2). Among 23
patients who achieved partial response, 15 responses were
confirmed, five responses were unconfirmed, and three patients are
pending confirmation. Responses were observed in 8/13 (62%)
patients that were previously treated with TKI. Median PFS was
5.6mo (95%-CI 5.06-NA). Furthermore, 13 patients were enrolled in
the HER2 cohort. Observed toxicities were similar to the EGFR
cohort except one case of grade 5 pneumonitis, assessed to be
possibly drug related. Twelve patients were evaluated for response
with an ORR of 50% (95% CI 21.1-78.9) at eight weeks and a DCR of
83%.
Conclusion
The trial exceeded the stopping boundary of ORR of 20%. In a
heavily pre-treated population with EGFR and HER2 exon 20 mutant
NSCLC, poziotinib provides a high ORR, an encouraging PFS, and a
manageable toxicity profile.
Conference Call Details:
Monday, September 24, 2018 @ 4:30
p.m. Eastern/1:30 p.m. Pacific
Domestic: (877) 837-3910, Conference ID#
1993267International: (973) 796-5077, Conference ID# 1993267
The conference call will also be webcast live. To access the
webcast and additional documents related to the call, please visit
the Investor Relations page of the Spectrum Pharmaceuticals
website
at http://investor.sppirx.com/events-and-presentations.
For interested individuals unable to join the call, a replay
will be available from September 24, 2018 @ 7:00 p.m.
ET/4:00 p.m. PT through October 1, 2018, until 7:30
p.m. ET/4:30 p.m. PT.
Domestic Replay Dial-In: (855) 859-2056,
Conference ID# 1993267International Replay Dial-In: (404) 537-3406,
Conference ID# 1993267
About Poziotinib
Poziotinib is a novel, orally available 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. Spectrum received an exclusive license from Hanmi
Pharmaceuticals to develop, manufacture, and commercialize
worldwide excluding Korea and China. Poziotinib is
currently being investigated by Spectrum and Hanmi in several
mid-stage trials in multiple solid tumor indications.
The poziotinib NSCLC clinical program for patients with EGFR or
HER2 exon 20 insertion mutations currently consists of a Phase 2
investigator-initiated study at The University of Texas MD Anderson
Cancer Center and 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.
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 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 role of
poziotinib in treating NSCLC patients with EGFR and HER2 exon 20
mutations and the advancement in treatment of such patients, the
results of the data scheduled to be presented on September 24, the
treatment potential of poziotinib to go beyond the previously
treated lung cancer setting, including other solid tumor
indications, Spectrum’s ability to expand the poziotinib clinical
program to explore poziotinib in new areas, Spectrum’s ability to
expand the NSCLC clinical program to Canada and Europe, the future
potential of Spectrum’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 Spectrum
and are subject to significant risks and uncertainties. Investors
are cautioned not to place undue reliance on any such
forward-looking statements. All such forward-looking statements
speak only as of the date they are made, and Spectrum undertakes no
obligation to update or revise these statements, whether as a
result of new information, future events or otherwise. Although
Spectrum believes that the expectations reflected in these
forward-looking statements are reasonable, these statements involve
many risks and uncertainties that may cause actual results to
differ materially from what may be expressed or implied in these
forward-looking statements, including, without limitation, the
uncertainties inherent in new product development, including
clinical trial results and additional analysis of existing clinical
data, the possibility that poziotinib may not ultimately prove to
be safe or effective, the possibility that Spectrum’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
poziotinib, if approved, may not be more effective, safer or more
cost efficient than competing drugs, and Spectrum’s dependence on
third parties for clinical trials, manufacturing, distribution and
quality control. 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, 2017, as amended, 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.
© 2018 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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version on businesswire.com: https://www.businesswire.com/news/home/20180905005998/en/
Spectrum Pharmaceuticals, Inc.Shiv KapoorVice President,
Strategic Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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