- Data were featured in an oral
presentation at the IASLC 19th World Conference on Lung Cancer
- Spectrum will host a live webcast today
at 4:30 p.m. Eastern/1:30 p.m. Pacific
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 preliminary poziotinib data from the University of Texas,
MD Anderson Cancer Center Phase 2 non-small cell lung cancer
(NSCLC) study which were released today during an oral presentation
at the IASLC 19th World Conference on Lung Cancer hosted by the
International Association for the Study of Lung Cancer. The MD
Anderson study is the single largest data set of patients with an
exon 20 mutation in EGFR or HER2.
“There are currently no approved targeted therapies for this
hard-to-treat population,” 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. “For this reason, it is especially exciting to observe that
poziotinib is highly active, with a manageable safety profile, in
these heavily pre-treated patients. The study is ongoing with
nineteen EGFR patients remaining on treatment, six of which have
been on drug for longer than a year. Poziotinib may offer a much
needed option to NSCLC patients with exon 20 mutations in EGFR or
HER2.”
In the interim analysis presented at the WCLC, the following
observations were made:
- This phase II study demonstrates high
anti-tumor activity for poziotinib in metastatic, heavily
pretreated EGFR exon 20 mutant NSCLC, a group for which no targeted
agents have proven effective to date (other than patients bearing
T790M or S768I mutations) with best response of PR in 55% of
evaluable patients (43% confirmed ORR to date; 19 patients remain
on treatment).
- Median PFS 5.5m; durable responses
observed with 6 treated for >1year thus far.
- Compares favorably to historical ORR
rates of <8% approved TKIs and <19% for standard of care 2L
agents (docetaxel, PD-1/PD-L1 inhibitors).
- Significant activity also observed in
HER2 exon 20-mutant NSCLC with initial responses observed in 50%
(6/12) evaluable patients and median PFS 5.1m.
- EGFR-related toxicities (including
rash, diarrhea, & paronychia) were manageable and required dose
reductions in 60%. Discontinuation due to poor tolerance was rare
(3%).
- Encouraging activity has prompted a
confirmatory, international, multicenter study in EGFR and HER2
exon 20 mutant NSCLC patients which is currently enrolling
(NCT03318939), including a first-line cohort, and development of a
separate pan-tumor basket study.
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. The
overall poziotinib clinical development program is focused on four
pillars, including previously treated NSCLC, first-line treatment
of NSCLC, combination therapy and treatment of other solid
tumors.
Following the oral presentation of data, Spectrum
Pharmaceuticals will be hosting a live webcast featuring Dr. John
Heymach.
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.
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
treatment potential of poziotinib to consistently deliver high
response and disease control rates for NSCLC patients with EGFR and
HER2 exon 20 mutations, the likelihood and timing of obtaining BTD
for poziotinib, Spectrum’s ability to execute on its clinical
development strategy of establishing a second and first-line
position in NSCLC, the treatment potential of poziotinib to go
beyond the previously treated lung cancer setting, including other
solid tumor indications and combination therapy, 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/20180924005695/en/
Spectrum Pharmaceuticals, Inc.Shiv KapoorVice President,
Strategic Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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