CAMBRIDGE, Mass., Nov. 9, 2018 /PRNewswire/ -- Leap
Therapeutics, Inc. (NASDAQ:LPTX) today presented clinical data from
its ongoing Phase I/II study of DKN-01 in combination with
paclitaxel in patients with advanced esophagogastric cancer at the
Society for Immunotherapy of Cancer (SITC) 33rd Annual
Meeting (SITC 2018).
The esophagogastric cancer clinical trial (P102) is a multipart
study of DKN-01 as a monotherapy and in combination with paclitaxel
or pembrolizumab. The arms evaluating DKN-01 plus paclitaxel
enrolled fifty-nine patients who had received one to seven prior
lines of therapy and were designed to assess the safety,
pharmacokinetics and efficacy of the combination.
The combination of DKN-01 and paclitaxel generated a 46.7%
overall response rate, 19.6 weeks median progression free
survival, and 61.1 weeks median overall survival in fifteen
evaluable patients as a second line therapy. In the benchmark
RAINBOW study, paclitaxel, as a monotherapy in second line
gastroesophageal junction or gastric cancer patients, generated a
16.1% overall response rate, 2.9 months of median progression free
survival, and 7.4 months median overall survival.
In addition, in the subgroup of twelve evaluable patients with
heavily pre-treated esophageal squamous cell carcinoma, the
combination of DKN-01 and paclitaxel produced a 33.3% overall
response rate, 13.7 weeks median progression free survival, and
31.0 weeks median overall survival.
"The combination of DKN-01 and paclitaxel has generated a
promising signal in second-line esophagogastric cancer patients,
with clinically meaningful response rate, progression-free survival
and overall survival data. In addition, there were
encouraging outcomes in patients with esophageal squamous cell
carcinoma, who have a significant unmet medical need and no
approved therapies," commented John H.
Strickler, MD, Assistant Professor of Medicine, Duke University Cancer Institute. "As GI
oncologists, we are looking to improve upon the standard single
agent therapies, and the combination of DKN-01 and paclitaxel
merits further exploration in randomized clinical trials."
Preclinical data also presented at SITC 2018 described the
mechanism of action of DKN-01 and immune mediated anti-tumor
activity in nonclinical models. A murine version of DKN-01
(mDKN-01) demonstrated efficacy in a melanoma tumor model.
However, mDKN-01 was unable to impede tumor growth in
immunodeficient mice, indicating that a functioning immune system
is required for antibody activity. Specifically, the activity of
DKN-01 was shown to require NK cells but not T or B cells,
representing activation of the innate immune system. In
preclinical models, the innate immune system activity of DKN-01
complemented the activity of paclitaxel and anti-PD-1
antibodies.
"To improve outcomes for patients with esophagogastric cancer,
we need to develop drugs with new mechanisms of actions. The
effect of DKN-01 on the innate immune system provides a strong
rationale for enhanced activity in combination with chemotherapy
and checkpoint inhibitors," commented Victoria M. Villaflor, MD, Associate Professor
of Medicine, Northwestern University. "The DKN-01 clinical
data with paclitaxel and as previously presented with Keytruda
reflects the clinical translation of these complementary mechanisms
and should be studied further as an important new approach for
treating esophagogastric cancer patients."
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 cancer, hepatobiliary
cancer, and gynecologic 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.
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
expectations with respect to the development and advancement of
DKN-01 and TRX518, including the initiation, timing, design and
results of future studies, enrollment in future studies, business
development, and other future expectations, plans and prospects.
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 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 Securities and Exchange Commission (the "SEC"), including
Leap Therapeutics' Form 10-K that Leap filed with the SEC on
February 23, 2018. 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:
Leap Therapeutics, Inc.
Douglas E. Onsi
Chief Financial Officer
donsi@leaptx.com
617-714-0360
Argot Partners
Investor Relations
Heather Savelle
Mary Jenkins
212-600-1902
heather@argotpartners.com
mary@argotpartners.com
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SOURCE Leap Therapeutics, Inc.