CAMBRIDGE, Mass., Aug. 6, 2019 /PRNewswire/ -- Leap
Therapeutics, Inc. (NASDAQ: LPTX) today announced that its
anti-Dickkopf-1 (DKK1) antibody,
DKN-01, in combination with Merck's anti-PD-1 antibody,
Keytruda® (pembrolizumab), demonstrated higher
survival and objective response outcomes in patients with advanced
gastroesophageal junction and gastric cancer (GEJ/GC) whose tumors
expressed high levels of DKK1
(DKK1-high). DKN-01 plus
Keytruda therapy achieved over 22 weeks median progression-free
survival (PFS) and nearly 32 weeks median overall survival (OS)
with a 50% overall response rate (ORR) and 80% disease control rate
(DCR) in patients with DKK1-high
GEJ/GC who had not received prior anti-PD-1/PD-L1 therapy. Leap
will host a DKN-01 Clinical Perspectives and Program Update for the
investment community through a live conference call and webcast
with two clinical investigators today at 8:30 AM US Eastern Time.
"Gastric and gastroesophageal junction cancers represent a
major global cancer burden with significant unmet needs,
particularly in patients with advanced disease. Outside of
rare microsatellite instable tumors and EBV-associated cancers the
response rates to immune checkpoint inhibitors are low and
median progression free survival remains short, in the range
of 6-8 weeks. Oncologists and patients are eager for new
therapeutic combinations and biomarkers to help predict patients
most likely to benefit from a given treatment," stated
Samuel J. Klempner, MD, Assistant
Professor, Massachusetts General Hospital Cancer Center and Harvard
Medical School.
"The responses and early survival data seen in
DKK1-high patients treated with
DKN-01 plus pembrolizumab are highly encouraging," commented
Dr. Klempner. "This study builds on previously reported
positive monotherapy and paclitaxel combination data
and importantly suggests that elevated DKK-1 expression is a potential predictive
biomarker. DKN-01 warrants further study in
gastroesophageal cancers in combination with immune checkpoint
inhibitors and with chemotherapy."
Key Findings from KEYNOTE-731 DKN-01 plus Keytruda
Combination
The esophagogastric cancer clinical trial is a multipart study
of DKN-01 as a monotherapy and in combination with paclitaxel or
pembrolizumab. Sixty-three patients were treated with DKN-01 plus
Keytruda combination therapy across all arms and dose groups of the
study. Fifty-three patients had not received prior PD-1/PD-L1
therapy, and ten patients were refractory to PD-1/PD-L1 therapy.
All of the patients enrolled had tumors that were microsatellite
stable or unknown. Patients in the study were heavily pretreated
having had received one to five prior lines of therapy, with nearly
64% having received a prior taxane regimen, 37% having received
prior ramucirumab, and 24% having received prior trastuzumab.
The combination therapy was well tolerated with no new safety
signals.
The combination of DKN-01 and Keytruda in GEJ/GC patients
demonstrated improved outcomes in patients whose tumors are
DKK1-high and who were PD-1/PD-L1
naïve. DKK1-high patients experienced
over 22 weeks median PFS and nearly 32 weeks OS, with a 50% ORR and
80% DCR in ten evaluable patients. DKK1-low patients experienced nearly 6 weeks
median PFS and over 17 weeks OS, with a 20% DCR in fifteen
evaluable patients.
PD-L1 Combined Positive Scores (CPS) did not predict efficacy on
the combination of DKN-01 plus Keytruda. In multi-variate analysis,
DKK1-high status correlated with
longer PFS independent of PD-L1 CPS scores. One-third of patients
in the study were DKK1-high.
Among the six GEJ/GC patients who were refractory to PD-1/PD-L1
therapy, three DKK1-high patients had
a best response of stable disease, whereas the three patients with
DKK1-low tumors had progressive
disease.
DKN-01 Clinical Perspectives Conference Call and
Webcast
Samuel J. Klempner, MD, Assistant
Professor, Massachusetts General Hospital Cancer Center and
Harvard Medical School, will describe
his experience with treating esophagogastric cancer patients in the
DKN-01 study. In addition, Rebecca C.
Arend, MD, Assistant Professor and Associate Scientist,
Gynecologic Oncology Clinic, UAB Comprehensive Cancer Center
Experimental Therapeutics Program, will discuss her experience with
endometrial cancer and carcinosarcoma patients treated with
DKN-01.
To access the conference call, please dial (866) 589-0108
(US/Canada Toll-Free) or (409) 231-2048 (international) and refer
to conference ID 3571417. The presentation will also be webcast
live and will be available under "Events & Presentations" in
the Investor section of Leap's website,
https://www.leaptx.com/program-webcasts. A replay of the webcast
will be available on Leap's website shortly after the event and
will be available for a limited time.
About Leap Therapeutics
Leap Therapeutics (NASDAQ: LPTX) is focused on developing
targeted and immuno-oncology therapeutics. Leap's most advanced
clinical candidate, DKN-01, is a humanized monoclonal antibody
targeting the Dickkopf-1 (DKK1)
protein, a Wnt pathway modulator. DKN-01 is in clinical trials in
patients with esophagogastric, hepatobiliary, gynecologic, and
prostate cancers. Leap's second clinical candidate, TRX518, is a
humanized GITR agonist monoclonal antibody designed to enhance the
immune system's anti-tumor response that is in advanced solid tumor
studies. For more information about Leap Therapeutics, visit
http://www.leaptx.com or our public filings with the SEC that are
available via EDGAR at http://www.sec.gov or via
https://investors.leaptx.com/.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, Section
21E of the Securities Exchange Act of 1934 and the Private
Securities Litigation Reform Act of 1995, which involve risks and
uncertainties. These statements include statements regarding Leap's
intended use of proceeds from the offering, Leap's expectations
with respect to the development and advancement of DKN-01, TRX518,
and other programs, including the initiation, timing and design of
future studies, enrollment in future studies, business development,
and other future expectations, plans and prospects. Leap has
attempted to identify forward looking statements by such
terminology as ''believes,'' ''estimates,'' ''anticipates,''
''expects,'' ''plans,'' ''projects,'' ''intends,'' ''may,''
''could,'' ''might,'' ''will,'' ''should,'' or other words that
convey uncertainty of future events or outcomes to identify these
forward-looking statements. Although Leap believes that the
expectations reflected in such forward-looking statements are
reasonable as of the date made, forward-looking statements are
subject to known and unknown risks, uncertainties and other factors
that could cause actual results to differ materially from our
expectations. Such risks and uncertainties include, but are not
limited to: the accuracy of our estimates regarding expenses,
future revenues, capital requirements and needs for financing; the
ability to complete a financing or form business development
relationships to fund our expenses; the outcome, cost, and timing
of our product development activities and clinical trials; the
uncertain clinical development process, including the risk that
clinical trials may not have an effective design or generate
positive results; our ability to obtain and maintain regulatory
approval of our drug product candidates; our plans to research,
develop, and commercialize our drug product candidates; our ability
to achieve market acceptance of our drug product candidates;
unanticipated costs or delays in research, development, and
commercialization efforts; the applicability of clinical study
results to actual outcomes; the size and growth potential of the
markets for our drug product candidates; our ability to continue
obtaining and maintaining intellectual property protection for our
drug product candidates; and other risks. Detailed information
regarding factors that may cause actual results to differ
materially will be included in Leap Therapeutics' periodic filings
with the SEC, including Leap's Annual Report on Form 10-K for the
fiscal year ended December 31, 2018,
as filed with the SEC on April 1,
2019 and Quarterly Report on Form 10-Q for the quarter ended
March 31, 2019, as filed with the SEC
on May 15, 2019. Any
forward-looking statements contained in this release speak only as
of its date. We undertake no obligation to update any
forward-looking statements contained in this release to reflect
events or circumstances occurring after its date or to reflect the
occurrence of unanticipated events.
CONTACT:
Douglas E. Onsi
Chief Financial Officer
Leap Therapeutics, Inc.
617-714-0360
donsi@leaptx.com
Heather Savelle
Investor Relations
Argot Partners
212-600-1902
heather@argotpartners.com
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SOURCE Leap Therapeutics, Inc.