-
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
HENDERSON, Nev.--(BUSINESS WIRE)--Sep. 24, 2018--
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# 1993267
International:
(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# 1993267
International
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20180924005695/en/
Source: Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, Inc.
Shiv Kapoor
Vice President,
Strategic Planning & Investor Relations
702-835-6300
InvestorRelations@sppirx.com
