On September 13, 2021 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the Company will be presenting initial data from the first-line cohort of the DisTinGuish study, a Phase 2a clinical trial evaluating Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab, BeiGene Ltd.’s anti-PD-1 antibody, and chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ), at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, being held virtually on September 16-21, 2021 (Press release, Leap Therapeutics, SEP 13, 2021, View Source [SID1234587588]). The Company will host a conference call on Friday, September 17, 2021 to discuss preliminary results from the study.

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"Initial data from the DisTinGuish study is extremely promising as it shows DKN-01 in combination with tislelizumab and chemotherapy to have high response rates in first-line patients suffering from gastric and gastroesophageal junction cancer," said Cynthia Sirard, MD, Chief Medical Officer of Leap. "Patients whose tumors have high levels of DKK1 expression, which is known to correlate with aggressive disease and poor prognosis, showed the highest response rates, suggesting how important the biomarker may be in predicting response to therapy. Additional data will be presented at ESMO (Free ESMO Whitepaper) and in our conference call to demonstrate the potential DKN-01 has as part of first-line therapy in this difficult-to-treat indication."

About the DisTinGuish Study

The DisTinGuish study (NCT04363801) is a Phase 2a 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 two parts, in the United States and the Republic of Korea. Enrollment of Part A has been completed with 25 first-line HER2- G/GEJ cancer patients whose tumors express either high levels of DKK1 (DKK1-high) or low levels of DKK1 (DKK1-low). Part B of the study will enroll up to 48 patients with second-line, DKK1-high G/GEJ cancer. Leap is conducting this combination study as part of an exclusive option and license agreement with BeiGene for the development of DKN-01 in Asia (excluding Japan), Australia, and New Zealand.

Key Findings

DKN-01 in combination with tislelizumab and chemotherapy demonstrated compelling overall response rates (ORR) as a first-line treatment for advanced G/GEJ cancer
In the primary efficacy analysis, including all patients who received a full cycle of DKN-01 therapy, the ORR was 68.2%, with 90% ORR in DKK1-high patients as compared to a 56% ORR in DKK1-low patients
In the overall intent to treat population, including those patients who did not receive a full cycle of therapy, the ORR was 60%, with 75% ORR in DKK1-high patients as compared to a 56% ORR in DKK1-low patients
As of the date of the abstract, 13 patients had experienced a partial response (PR), six patients had a best response of stable disease (SD), one patient was non-evaluable for response (NE), three patients were unable to complete a full cycle of therapy (non-modified ITT (mITT)), and two patients were pending their first tumor assessment. Of the 18 patients that had RNAscope DKK1 expression available for the abstract, 9 were DKK1-high [6 PR, 1 NE, and 2 non-mITT] and 9 were DKK1-low [5 PR, 4 SD]. Subsequent to the date of the abstract, the two patients who were pending their first scan for response to therapy were determined to have had PRs, and three additional patients were determined to have had DKK1-high tumors, each of whom experienced a PR.

Further results will be presented at the ESMO (Free ESMO Whitepaper) 2021 Congress from September 16 to 21, 2021.

Leap Presentation Details:

Title: DKN-01 in combination with tislelizumab and chemotherapy as a first-line therapy in unselected patients with advanced gastroesophageal adenocarcinoma (GEA): DisTinGuish Trial
Abstract Number: 2218
Session type: E-Poster Presentation
Presenter: Samuel J. Klempner, Harvard Medical School
Date and time: Thursday, September 16, 2021; 2:30 a.m. ET

Conference Call

Leap will host a conference call on Friday, September 17, 2021 at 8:00 a.m. Eastern Time to further discuss the data. In addition to Leap’s executive management team, Dr Jaffer Ajani of M.D. Anderson Cancer Center and Dr. Samuel Klempner of Massachusetts General Hospital will be on the call. The call can be accessed by dialing (866) 589-0108 (U.S. and Canada) or (409) 231-2048 (international). The passcode for the conference call is 1729397. The presentation will be webcast live and may be accessed on the Investors page of the Company’s website at View Source, where a replay of the event will also be available for a limited time.