ASCO-GI – investors want a better look before they Leap

If Leap Therapeutics had hoped for a boost from early data with its lead project DKN-01 in colorectal cancer, it will have been disappointed yesterday. The group’s stock sank 5% on release of an ASCO-GI abstract detailing a 30% overall response rate in the uncontrolled lead-in portion of the Defiance study, testing DKN-01 plus Avastin and chemo in second-line disease. This was comfortably above the prespecified 20% ORR bar; however, around half of patients hadn't received prior Avastin, so much of the result might have been driven by response to the approved drug. A poster will be presented on Saturday, followed by a conference call next Tuesday, when investors will await details of responses in Avastin-experienced and naive patients. DKN-01’s benefit should also become clearer with data from the randomised portion of Defiance, which is due to enrol by mid-2024. Leap has another big readout due this year, of the Distinguish trial testing DKN-01 plus BeiGene’s tislelizumab and chemo in gastric cancer. The company is one of only a handful evaluating DKK1 inhibition – its most advanced rival, according to OncologyPipeline, is Junshi Biosciences, whose JS015 is in a Chinese phase 1/2 study in solid tumours.

Leap Therapeutics’ pipeline

Notes: *Investigator-sponsored trial; **via Flame acquisition. Source: OncologyPipeline & company presentations.