Lisata Therapeutics announced preliminary data from Cohort A of its Phase 2 ASCEND trial evaluating certepetide, combined with standard chemotherapy, for metastatic pancreatic ductal adenocarcinoma (mPDAC). The data showed a positive trend in overall survival (mOS) for the certepetide group (12.68 months) compared to the placebo group (9.72 months), and four complete responses were observed in the certepetide group versus none in the placebo group. Data from Cohort B, which uses a different dosing regimen, are expected soon.
This preliminary data is promising for mPDAC patients, who face a dismal prognosis with current standard-of-care treatments. The observed improvement in overall survival and the presence of complete responses, albeit in a small number of patients, suggest that certepetide may offer a meaningful clinical benefit. This is particularly significant given the limited treatment options available for this aggressive cancer. Positive results from Cohort B would further strengthen the case for certepetide’s potential to improve outcomes for these patients.
Cohort A enrolled 95 patients and administered a single dose of certepetide or placebo alongside standard chemotherapy. While median progression-free survival (PFS) showed no significant difference between the groups, the positive trend in mOS and the complete responses are encouraging. Cohort B is evaluating a two-dose regimen of certepetide, and the company anticipates even stronger results from this cohort, particularly in PFS.
These early findings support Lisata’s plan to progress certepetide to Phase 3 trials in early 2026. Confirmation of these positive trends in Cohort B and subsequent Phase 3 trials could position certepetide as a valuable addition to the current treatment landscape for mPDAC, offering new hope for patients with this challenging cancer.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
