Lisata Therapeutics says IDSMC recommends study continuation of ASCEND trial

Lisata Therapeutics announced a outcome of the prespecified interim futility analysis for the ASCEND trial, a Phase 2b study evaluating LSTA1, Lisata’s lead investigational product, in combination with standard-of-care gemcitabine/nab-paclitaxel in patients with first-line, metastatic pancreatic ductal adenocarcinoma. Based on the results of the interim futility analysis, which was reviewed by the study’s Independent Data Safety Monitoring Committee, the ASCEND trial will continue as planned without modification. The ASCEND trial is a 155-patient, double-blind, randomized, placebo-controlled Phase 2b clinical trial being conducted at up to 40 sites in Australia and New Zealand, led by the Australasian Gastro-Intestinal Trials Group in collaboration with the University of Sydney and with the National Health and Medical Research Council Clinical Trial Centre at the University of Sydney as the Coordinating Centre. The trial is fully funded by Lisata through an unrestricted research support agreement. The trial is approved by the Sydney Local Health District Ethics Review Committee. ASCEND, based upon Cohort A, has 80% power with 95% confidence to detect a 16% increase in the 6-month progression free survival rate in the experimental arm vs. the control arm. Trial enrollment completion is projected for the first half of 2024; however, current enrollment already exceeds 80% of the target, so earlier enrollment completion may be achieved.