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.
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.
Leap Therapeutics, Inc.
Douglas E. Onsi
Chief Financial Officer
SOURCE Leap Therapeutics, Inc.