FDA Gives Fast Track Designation for Gastric, Gastroesophageal Junction Adenocarcinoma Treatment

The FDA has granted a fast track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction (GEJ) adenocarcinoma whose tumors have high DKK1 expression, who have progressed on or after a fluoropyrimidine- and platinum-containing chemotherapy, and HER2/neu targeted therapy, if appropriate, according to Leap Therapeutics, Inc.¹

“We are pleased with the FDA’s decision to grant fast track designation for the development of DKN-01 to treat patients with gastric and GEJ cancer whose tumor express high levels of DKK1,” Douglas E. Onsi, president and chief executive officer of Leap Therapeutics, Inc, stated in a press release. “The designation highlights the existing unmet medical need for new and effective treatments for this patient population. We believe that DKN-01 shows promise as a novel treatment option for biomarker-selected patients with these cancers, and this designation provides us with earlier and more frequent opportunities to interact with the FDA during the development of DKN-01.”

DKN-01 is a humanized monoclonal antibody that was developed to blind to and block the activity of the DKK1 protein, which serves as a modulator of the Wnt/Beta-catenin signaling pathway that is frequently involved in tumorigenesis and immune system suppression. In the phase 1/2 P102/KEYNOTE-731 trial (NCT02013154) of DKN-01, investigators examined the agent as a monotherapy and in combination regimens in previously treated patients with advanced esophagogastric cancer.2 Participants were given single-agent DKN-01, DKN-01 plus paclitaxel, or DKN-01 plus pembrolizumab (Keytruda).

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