Lisata Therapeutics Inc (NASDAQ:LSTA), in collaboration with the Australasian Gastro-Intestinal Trials Group and the NHMRC Clinical Trials Centre at the University of Sydney, announced positive preliminary results from Cohort B of the ASCEND Phase 2b clinical trial evaluating certepetide in combination with standard-of-care chemotherapy in metastatic pancreatic ductal adenocarcinoma (mPDAC).
The ASCEND trial is a 158-patient, double-blind, randomized, placebo-controlled study assessing the addition of certepetide to standard-of-care gemcitabine and nab-paclitaxel.
Patients were enrolled from 24 clinical sites across Australia and Aotearoa New Zealand between May 2022 and December 2023.
The trial includes two sequentially enrolled cohorts with distinct dosing regimens. Cohort A used a single 3.2 mg/kg dose of certepetide administered intravenously after gemcitabine and before nab-paclitaxel. Cohort B followed the same schedule but added a second dose of certepetide or placebo four hours later.
Preliminary data from Cohort A, unveiled in January, showed a positive trend in overall survival, including four complete responses in the certepetide group and none in the placebo group.
Lisata reported on Thursday that preliminary results from Cohort B show a six-month progression-free survival rate of 60.8% in the certepetide-treated group compared to 25% in the placebo group.
Median progression-free survival was 7.5 months for patients receiving certepetide, versus 4.7 months for those receiving placebo.
The objective response rate was 45.2% in the certepetide group and 19% in the placebo group.
Median overall survival was reported at 10.32 months for the certepetide group and 9.23 months for the placebo group.
Comparison of Cohort A and B data suggests that the addition of a second dose of certepetide in Cohort B may enhance treatment efficacy, particularly in progression-free survival and objective response rate, while maintaining a favorable safety profile, Lisata said.
“We are pleased with the promising Cohort B data of the ASCEND trial. These data, taken with those previously reported for Cohort A, reinforce our confidence in the therapeutic promise of certepetide,” Lisata CEO Dr David Mazzo said in a statement.
“Along with its attractive safety profile, we continue to believe that certepetide has the potential to transform the treatment landscape for mPDAC and many other devastating solid tumors.”
The Cohort B findings will be presented by Study Chair Dr Andrew Dean on July 2 at the European Society for Medical Oncology Gastrointestinal Cancers Congress in Barcelona.
“The data from ASCEND provides us with critical new knowledge that will significantly enhance our understanding of how to optimally treat patients battling pancreatic cancer,” Dr Dean said.
“We are excited by the evidence of certepetide’s therapeutic effect and encourage the continued development of this potentially treatment paradigm-changing compound.”
Final data from both cohorts are expected to be released later in 2025.