Leap Therapeutics, Inc. (Nasdaq: LPTX) today announced the presentation of updated positive 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) Congress. The Company will host a conference call on Friday, September 17, 2021 to discuss preliminary results from the study.

The Company announced positive initial data from the DisTinGuish study on Monday, September 13, 2021 based on 25 G/GEJ patients enrolled in the trial that showed DKN-01 in combination with tislelizumab and chemotherapy as first-line therapy was well tolerated with compelling activity. The results presented at the ESMO Congress today included additional patient data stratified by tumoral PD-L1 expression levels based on visually-estimated combined positive score (vCPS), showing that robust objective clinical responses can be achieved from this combination regimen independently of PD-L1 expression.

"Initial data from this trial have shown that patients with high levels of DKK1 expression, a group with a poor prognosis, had encouraging responses to treatment. The additional data presented today show evidence that not only is DKK1 a critical biomarker in predicting response to DKN-01 and tislelizumab therapy, but also that the combination can induce deep responses regardless of the patient's PD-L1 status, including particularly poor prognosis patients with both low PD-L1 and high DKK1," said Samuel Klempner, MD, Member of the Faculty at Massachusetts General Hospital Cancer Center and Harvard Medical School. "Taken together, these are promising results for the combination therapy of DKN-01 with tislelizumab and chemotherapy in first line patients with gastric or gastroesophageal junction cancers."