-
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
Company Website:
http://www.sppirx.com
HENDERSON, Nev. -- (Business Wire)
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# 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.
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20180905005998/en/
Contacts:
Spectrum Pharmaceuticals, Inc.
Shiv Kapoor
Vice President,
Strategic Planning & Investor Relations
702-835-6300
InvestorRelations@sppirx.com
Source: Spectrum Pharmaceuticals, Inc.
© 2024 Canjex Publishing Ltd. All rights reserved.