Leap Therapeutics has reported positive results from the KEYNOTE-731 clinical trial of its anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with Merck’s anti-PD-1 antibody, Keytruda (pembrolizumab).
The trial demonstrated higher survival and objective response outcomes in patients with advanced gastroesophageal junction and gastric cancer (GEJ/GC).
Go deeper with GlobalData
The DKN-01 and Keytruda combination treatment achieved more than 22 weeks median progression-free survival (PFS) and 32 weeks median overall survival (OS) with a 50% overall response rate (ORR) and 80% disease control rate (DCR).
DKK1-low patients experienced roughly six weeks median PFS and over 17 weeks OS, with a 20% DCR in 15 evaluable patients.
Massachusetts General Hospital Cancer Center and Harvard Medical School assistant professor Samuel Klempner said: “The responses and early survival data seen in DKK1-high patients treated with DKN-01 plus pembrolizumab are highly encouraging.
“This study builds on previously reported positive monotherapy and paclitaxel combination data and importantly suggests that elevated DKK-1 expression is a potential predictive biomarker.”
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataThe esophagogastric cancer clinical trial, KEYNOTE-731, is a multipart study of DKN-01 as a monotherapy and in combination with paclitaxel or pembrolizumab.
A total of 63 GEJ/GC patients received DKN-01 and Keytruda combination therapy across all arms and dose groups of the study.
The combination demonstrated improved outcomes in patients whose tumors are DKK1-high and who were PD-1/PD-L1 naïve.
PD-L1 Combined Positive Scores (CPS) did not predict efficacy on the combination.
Among the six GEJ/GC patients who were refractory to PD-1/PD-L1 therapy, three DKK1-high patients had the best response of stable disease.
The three patients with DKK1-low tumours had progressive disease.
In June 2017, Leap Therapeutics signed a clinical trial collaboration agreement with Merck to investigate DKN-01 in combination with Keytruda.
