Leap Therapeutics Inc. (NASDAQ: LPTX) has announced that they will update results from the DisTinGuish study, a phase 2a clinical study investigating its ant-Dickkopf (DKK1) antibody, DKN-10, combination with BeiGene’s antibody PD-1 antibody, tislelizumab, in gastroesophageal junction cancer at the 2022 American Society of Clinical Oncology Gastrointestinal Cancer Symposium. In addition, the company will hold a conference call on January 21, 2022, with Samuel Klempner, principal DisTinGuish study investigator, to discuss the results.
Part A included first-line G/GEJ patients
DisTinGuish study’s Part A, which included first-line progressed G/GEJ patients treated with DKN-01 combination with tislelizumab plus chemotherapy, will be discussed. New data show that this combo regimen has a high level of efficacy, as seen by improved clinical response and survival benefits linked with elevated tumoral DKK1 expression, which is unrelated to PD-L1 expression. In addition, initial results from the currently enrolling Part B of the clinical study will evaluate DKN-01 and tislelizumab in 2nd advanced G/GEJ subjects with elevated tumoral DKK1 expression will also be presented, demonstrating that the drug was well tolerated with inspiring objective responses.
Klempner said, “The combination of DKN-01 with tislelizumab continues to demonstrate encouraging results in patients with gastric and gastroesophageal junction cancer, especially those in the DKK1-high subpopulation. The updated front-line results are encouraging in a difficult to treat cohort of primarily PD-L1 low patients, who are less likely to benefit from anti-PD-1 therapy. Together with encouraging initial findings from Part B, where DKN-01 and tislelizumab are used as a chemo-free second-line treatment of DKK1 high-expressing tumors, these results continue to support the therapeutic potential of DKN-01 and warrant exploration in a randomized clinical trial in first-line gastric and gastroesophageal junction patients.”
DKN-01 granted Fast Track Designation
The United States FDA has awarded DKN-01 Orphan Drug Designation for gastric and gastroesophageal junction cancer treatment, as well as Fast Track Designation as a combination with tislelizumab for treatment of gastric and gastroesophageal junction adenocarcinoma patients whose tumors express elevated DKK1 protein, after disease progression after or on prior fluoropyrimidine- and platinum-containing chemo and, if suitable, human epidermal receptor growth factor neu-targeted therapy.