30% ORR and
93% DCR across heterogenous second-line CRC
patients
treated with DKN-01 plus bevacizumab and
chemotherapy
Subgroup analysis reveals greatest benefit in
left-sided tumors, particularly rectal and rectosigmoid patients
with
46% ORR, 100% DCR, and preliminary
median PFS of 9.4 months.
Leap to host conference call to report
additional clinical data including further subgroup
analyses
on Tuesday, January 23,
2024 at 8:30 a.m. ET
CAMBRIDGE, Mass., Jan. 16,
2024 /PRNewswire/ -- Leap Therapeutics, Inc.
(Nasdaq:LPTX), a biotechnology company focused on developing
targeted and immuno-oncology therapeutics, today announced new data
from Part A of the DeFianCe study, a Phase 2 study evaluating
DKN-01, Leap's anti-Dickkopf-1 (DKK1)
antibody, in combination with standard of care bevacizumab and
chemotherapy in second-line patients with advanced colorectal
cancer (CRC), to be presented at the upcoming 2024 American Society
of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium
taking place in San Francisco, CA
and virtually on January 18-20,
2024.
"Data from Part A of the DeFianCe study demonstrates that the
addition of DKN-01 to bevacizumab and chemotherapy can generate
clinically meaningful response rates and durable tumor reductions
with a favorable safety profile in second-line CRC patients,
particularly those with rectal or rectosigmoid tumors," said
Meredith Pelster, MD, Assistant
Director of Gastrointestinal Research at Sarah Cannon Research
Institute and a study investigator. "We are very interested in
utilizing DKN-01 to modulate the Wnt pathway, which is active in a
high percentage of CRC patients, particularly left-sided tumors, to
overcome resistance to chemotherapy, and to decrease angiogenesis
in order to enhance the activity of the standard of care
bevacizumab plus chemotherapy regimens. These results provide a
strong foundation for the randomized controlled Part B of this
study, which is enrolling extremely well and expected to complete
enrollment mid-year."
"In this heterogenous second-line population with several
unfavorable characteristics, the DKN-01 plus bevacizumab and
chemotherapy Part A ORR of 30%,
with a disease control rate of over 90%, and enhanced activity in
left-sided tumors and rectal tumors, with a 46% ORR and 9.4 month preliminary PFS, represent
an encouraging efficacy signal," said Zev
Wainberg, MD, Professor of Medicine and Co-Director of the
GI Oncology Program at UCLA. "CRC is a
heterogenous disease where the selection of therapy and expected
outcomes vary based on whether the tumor is on the left or right
side, the presence or absence of genetic mutations, microsatellite
instability, and prior therapy. Physicians want to be able to
select a second-line therapy combination based on the patient's
personalized tumor characteristics, which is what we hope to
achieve by adding DKN-01 and understanding the subgroups with the
greatest clinical benefit."
Leap will host a conference call on January 23, 2024 at 8:30
a.m. Eastern Time in which Dr. Pelster and Dr. Wainberg will
further discuss the new data from the DeFianCe study.
Key Findings:
- As of the December 6, 2023 data
cutoff, 33 patients enrolled in Part A of the DeFianCe
study
- Across all evaluable patients with second-line
microsatellite stable CRC (n=27):
- Objective response rate (ORR)
was 30% and disease control rate (DCR) was 93%, including 8 partial
responses (PR) and 17 patients with a best response of stable
disease (SD)
- Median progression-free survival (PFS) was 6.3 months
- 9 patients remain on therapy beyond 8.5 months
- Analysis revealed a breadth of clinical activity across
additional subgroups, including patients with left-sided tumors
(n=25)
- 33% ORR and 100% DCR in response-evaluable population (7
PRs, 14 SDs)
- Preliminary median PFS of 8.6 months (9 patients continuing on
therapy within subgroup)
- Patients with rectal/rectosigmoid carcinomas (n=15) represent
an important subpopulation:
- 46% ORR and 100% DCR in response-evaluable population (6
PRs, 7 SDs)
- Preliminary median PFS of 9.4 months (6 patients continuing on
therapy within subgroup)
- Higher baseline plasma DKK1
levels correlated with improved responses
- DKN-01 plus bevacizumab and chemotherapy was
well-tolerated, with a majority of DKN-01 related events being low
grade (Grade 1/2)
- Randomized controlled Part B of the study is underway with 54
patients currently enrolled
Conference Call:
Leap's management team, together with
Dr. Pelster and Dr. Wainberg, will host a conference call on
Tuesday, January 23, 2024 at
8:30 a.m. Eastern Time to further
discuss the data. The conference call will be broadcast live in
listen-only mode and can be accessed via the website URL:
https://edge.media-server.com/mmc/p/q5zrz568. A replay of the event
will also be available for a limited time on the Investors page of
the Company's website at https://investors.leaptx.com/.
About the DeFianCe Study
The DeFianCe study
(NCT05480306) is a Phase 2, open-label, global study of DKN-01 in
combination with standard of care bevacizumab and chemotherapy in
patients with advanced CRC who have received one prior systemic
therapy for advanced disease. The Part A cohort enrolled 33
patients, including significant numbers of patients who had early
progression on first-line therapy, previous exposure to
bevacizumab, tumors with Ras mutations, or liver metastases. The
study has expanded into a 130-patient Part B randomized controlled
trial. The primary objective of the study is progression free
survival. Secondary objectives include overall response rate,
duration of response, and overall survival.
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. DKN-01 is being developed in
patients with esophagogastric, gynecologic, and colorectal cancers.
FL-301, is a humanized monoclonal antibody targeting Claudin18.2,
being developed in patients with gastric and pancreatic cancer.
Leap also has preclinical antibody programs targeting
Claudin18.2/CD137 and GDF15. For more information about Leap
Therapeutics, visit http://www.leaptx.com or view our public
filings with the SEC that are available via EDGAR at
http://www.sec.gov or via https://investors.leaptx.com/.
FORWARD-LOOKING STATEMENTS
This press release contains
forward-looking statements within the meaning of the federal
securities laws. Such statements are based upon current plans,
estimates and expectations of the management of Leap that are
subject to various risks and uncertainties that could cause actual
results to differ materially from such statements. The inclusion of
forward-looking statements should not be regarded as a
representation that such plans, estimates and expectations will be
achieved.
All statements, other than historical facts, including
statements regarding the anticipated timing for completion of or
success of enrollment in the DeFianCe study or any other clinical
trial, the release of clinical data, and any outcomes of such
trials; the potential, safety, efficacy, and regulatory and
clinical progress of Leap's product candidates, including DKN-01;
and any assumptions underlying any of the foregoing, are
forward-looking statements. Important factors that could cause
actual results to differ materially from Leap's plans, estimates or
expectations could include, but are not limited to: (i) Leap's
ability to successfully execute its clinical trials and the timing
of enrollment in and cost of such clinical trials; (ii) the results
of Leap's clinical trials and pre-clinical studies; (iii) Leap's
ability to successfully enter into new strategic partnerships for
DKN-01 or any of its other programs; (iv) whether any Leap clinical
trials and products will receive approval from the U.S. Food and
Drug Administration or equivalent foreign regulatory agencies; (v)
exposure to inflation, currency rate and interest rate
fluctuations, as well as fluctuations in the market price of Leap's
traded securities; and (vi) that the initiation, conduct, and
completion of clinical trials, laboratory operations, manufacturing
campaigns, and other studies may be delayed, adversely affected, or
impacted by global conflict, or supply chain related issues. New
risks and uncertainties may emerge from time to time, and it is not
possible to predict all risks and uncertainties. No representations
or warranties (expressed or Implied) are made about the accuracy of
any such forward-looking statements. Leap may not actually achieve
the forecasts disclosed in such forward-looking statements, and you
should not place undue reliance on such forward-looking statements.
Such forward-looking statements are subject to a number of material
risks and uncertainties including but not limited to those set
forth under the caption "Risk Factors" in Leap's most recent Annual
Report on Form 10-K filed with the SEC, as well as discussions of
potential risks, uncertainties, and other important factors in its
subsequent filings with the SEC. Any forward-looking statement
speaks only as of the date on which it was made. Neither Leap, nor
any of its affiliates, advisors or representatives, undertake any
obligation to publicly update or revise any forward-looking
statement, whether as result of new information, future events or
otherwise, except as required by law. These forward-looking
statements should not be relied upon as representing Leap's views
as of any date subsequent to the date hereof.
CONTACT:
Douglas E. Onsi
President & Chief Executive Officer
Leap Therapeutics, Inc.
617-714-0360
donsi@leaptx.com
Matthew DeYoung
Investor Relations
Argot Partners
212-600-1902
leap@argotpartners.com
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