Lisata Therapeutics Inc (NASDAQ:LSTA) has reported encouraging preliminary data for Cohort A of its ongoing ASCEND Phase 2 trial.
The trial, conducted across 25 sites in Australia and New Zealand, is evaluating the efficacy of Lisata’s novel therapy certepetide in combination with standard-of-care chemotherapy for the treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC), an aggressive form of pancreatic cancer.
Cohort A consists of 95 patients receiving a single intravenous dose of certepetide or placebo in addition to the standard-of-care chemotherapy.
Preliminary results revealed a median overall survival of 12.68 months in the certepetide group compared to 9.72 months in the placebo group.
While the six-month progression-free survival data showed a numerical trend favoring certepetide, no significant difference in median PFS (mPFS) was observed, with both groups reporting a median of 5.5 months.
Notably, four complete responses were observed in the certepetide treatment group, with no complete responses in the placebo group.
A second cohort, Cohort B, is investigating the efficacy of two intravenous doses of certepetide administered four hours apart in combination with standard-of-care chemotherapy.
Data from Cohort B is anticipated in the coming months, with a full report of findings from both cohorts to follow.
“The data from Cohort A are as we expected and corroborate our decision to add Cohort B to the ASCEND protocol,” said Dr Kristen Buck, Lisata’s chief medical officer.
“The increase in overall survival and the observation of four complete responses in the certepetide-treated group compared to none in the placebo group for Cohort A, coupled with our expectation of even better outcomes in Cohort B, where we believe early indications show a strong separation in mPFS benefiting patients treated with certepetide, support our plans to advance certepetide development to Phase 3 in early 2026.”