- 19.5 months median OS in the overall first-line patient
population, exceeding current benchmarks
- Long-term follow-up identifies additional patient with
partial response, resulting in 73% ORR in overall mITT population,
including 86% ORR in PD-L1-low patients
CAMBRIDGE, Mass., May 25, 2023 /PRNewswire/ -- Leap
Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused
on developing targeted and immuno-oncology therapeutics, today
announced the Company will be presenting new long-term follow-up
data in first-line patients with advanced gastric or
gastroesophageal junction adenocarcinoma (GEA) from Part A of the
DisTinGuish study, a Phase 2 clinical trial evaluating Leap's
anti-Dickkopf-1 (DKK1) antibody,
DKN-01, in combination with BeiGene's tislelizumab and
chemotherapy, at the upcoming 2023 American Society of Clinical
Oncology (ASCO) Annual Meeting taking place in Chicago, IL on June
2-6, 2023.
"The long-term follow-up data for DKN-01 in combination with
tislelizumab and chemotherapy indicates a novel and well-tolerated
treatment with the potential for enhanced response rate, survival,
and quality of life for advanced GEA patients," said Samuel Klempner, MD, Associate Professor at
Harvard Medical School and principal
investigator on the DisTinGuish study. "Median overall survival and
progression-free survival for patients treated with DKN-01 plus
tislelizumab and chemotherapy exceeded current PD-1 combination
benchmarks, especially for those patients with low expression of
PD-L1. Together with the previously reported data on the
encouraging outcomes with DKN-01 for patients with high
DKK1 expression, these results
provide strong support for the ongoing randomized controlled
clinical trial in first-line GEA patients."
"We are excited about the latest data from Part A of the
DisTinGuish study which continues to show DKN-01 plus tislelizumab
and chemotherapy as a safe and active treatment where tumor
reductions can continue to deepen over time. It is extremely
encouraging to see an additional patient achieve a partial
response, which is ongoing, after 22 months on therapy," said
Cynthia Sirard, MD, Chief Medical
Officer of Leap Therapeutics. "A 90% overall response rate in
DKK1-high patients and 86% overall
response rate in PD-L1 low patients, both of which are associated
with poor outcomes, along with 11.3 months median progression-free
survival and 19.5 months median overall survival in the full
population, demonstrates the important potential of DKN-01. We look
forward to completing enrollment in the randomized controlled
clinical trial late this year and seeing data from our ongoing
colorectal cancer trial in the coming months."
Key Findings Part A DisTinGuish
- Median overall survival (OS) of 19.5 months and median
progression-free survival (PFS) of 11.3 months exceeds benchmark
results in the overall first-line patient population (n=25)
- Compelling OS and PFS results in all four important biomarker
subgroups
-
- 18.7 months OS and 10.7 months PFS in PD-L1-low (vCPS < 5)
patients (n=16)
- 22.0 months OS and 11.6 months PFS in PD-L1-high (vCPS > 5)
patients (n=6)
- 16.9 months OS and 11.3 months PFS in DKK1-high patients (n=12)
- 24.4 months OS and 12.0 months PFS in DKK1-low patients (n=9)
- Additional patient with a partial response after 22 months on
therapy improves objective response rate (ORR) to 73% in the
overall modified intent-to-treat population (n=22), with one (5%)
complete response (CR), 15 (68%) partial responses (PR), 5 (23%)
best responses of stable disease (SD), and 1 (5%) non-evaluable
(NE)
-
- 86% ORR in PD-L1-low patients (n=14: 12 PR, 2 SD)
- 67% ORR in PD-L1-high patients (n-6: 1 CR, 3 PR, 1 SD, 1
NE)
- 90% ORR in DKK1-high patients (n=10: 9 PR, 1 NE)
- 67% ORR in DKK1-low patients (n=9: 1 CR, 5 PR, 3 SD)
- Consistent with previous results, combination was well
tolerated with manageable toxicity, with most adverse events
related to DKN-01 being low-grade (76%)
Leap Poster Details:
Title: A phase 2 study (DisTinGuish) of DKN-01 in
combination with tislelizumab + chemotherapy as first-line (1L)
therapy in patients with advanced gastric or GEJ adenocarcinoma
(GEA).
Presenter: Samuel J. Klempner, Harvard Medical School
Session Type: Poster Discussion Session
Session Title: Gastrointestinal
Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Date and Time: Monday, June 5, 2023, at 11:30 a.m. CT
Abstract Number: 4027
Poster Number: 335
About the DisTinGuish Study
The DisTinGuish study (NCT04363801) is a Phase 2 study of DKN-01
in combination with tislelizumab, an anti-PD-1 antibody, with or
without chemotherapy as first-line or second-line therapy in
patients with inoperable, locally advanced, G/GEJ adenocarcinoma.
The study is being conducted in three parts in the United States, the Republic of Korea, the
United Kingdom, and Germany. Part A enrolled 25 first-line HER2-
GEA cancer patients to receive DKN-01 in combination with
tislelizumab and capecitabine and oxaliplatin. Part B enrolled 52
second-line GEA cancer patients whose tumors expressed high levels
of DKK1 to receive DKN-01 in
combination with tislelizumab. Part C is enrolling approximately
160 first-line HER2- GEA cancer patients in a randomized controlled
trial of DKN-01 in combination with tislelizumab and chemotherapy
compared to tislelizumab and chemotherapy. Tislelizumab is provided
for the study through a clinical collaboration with BeiGene,
Ltd.
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. Words such as "anticipate," "expect," "project,"
"intend," "believe," "may," "will," "should," "plan," "could,"
"continue," "target," "contemplate," "estimate," "forecast,"
"guidance," "predict," "possible," "potential," "pursue," "likely,"
and words and terms of similar substance used in connection with
any discussion of future plans, actions or events identify
forward-looking statements.
All statements, other than historical facts, including
statements regarding the continuation over time of the clinical
collaboration with BeiGene on the ongoing Part C of the DisTinGuish
trial, with BeiGene continuing to supply tislelizumab; the
expected benefits of the merger with Flame Biosciences; the cash
runway into mid-2025 and the sufficiency of Leap's cash, cash
equivalents and short-term investments to fund operations;
stockholder approval of the conversion rights of the Series X
Non-Voting Convertible Preferred Stock; the anticipated timing for
initiation of or success of enrollment in clinical trials and
release of clinical data, and any outcomes of such trials; the
potential, safety, efficacy, and regulatory and clinical progress
of Leap's product candidates; our future preclinical and clinical
development plans in connection with our programs; the ability to
enter into a new strategic partnership for DKN-01 or any of Leap's
other programs; the ability of NovaRock Biotherapeutics to conduct
the FL-301 clinical trial in China; 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; (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 COVID-19, global conflict, or
supply chain related issues; (vii) Leap's ability to successfully
integrate the Flame operations and realize the anticipated benefits
of the acquisition of Flame; (viii) whether Leap's stockholders
approve the conversion of the Series X Non-Voting Convertible
Preferred Stock; (ix) whether Leap's cash resources will be
sufficient to fund Leap's continuing operations and the newly
acquired Flame operations, including the liabilities of Flame
incurred in connection with the completion of the merger; and (x)
Leap's ability to comply with the continued listing requirements of
the Nasdaq Capital Market. 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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