Lisata Therapeutics Inc (NASDAQ:LSTA) and WARPNINE announced the completion of patient enrollment in the Phase 1b/2a iLSTA trial, which is evaluating Lisata’s therapy candidate certepetide in combination with standard-of-care chemotherapy and immunotherapy in pancreatic cancer.
It is evaluating the therapy in patients with locally advanced non-resectable pancreatic ductal adenocarcinoma (PDAC), rather than metastatic PDAC.
The trial is being conducted exclusively at St John of God Subiaco Hospital in Western Australia, a tertiary private hospital known for its active clinical research unit.
Preliminary data from the trial were presented on in July at the ESMO Gastrointestinal Cancers (ESMO-GI) Congress, and showed an overall response rate of 60% and an overall disease control rate of 100% after four treatment cycles.
“Immunotherapy has largely been ineffective in this patient population, and thus, we were encouraged by the preliminary data presented this year at ASCO-GI, followed by updated preliminary data presented earlier this month at ESMO-GI,” Lisata’s chief medical officer Dr Kristen Buck said.
“We are hopeful that final data from the study will be equally encouraging.”
Participants in the trial were assigned to three groups in a 1:1:4 ratio. Cohort 1 received standard chemotherapy with two placebos, Cohort 2 received standard chemotherapy with certepetide and a placebo for the immunotherapy durvalumab, and Cohort 3 received standard chemotherapy with both certepetide and durvalumab.
The preliminary data showed that among the 20 participants, 13 demonstrated a RECIST partial response, including 11 patients from Cohort 3.
One participant in Cohort 2 exhibited a RECIST complete response, while the remaining six participants had stable disease with less than a 22% decrease in tumor size. No participant experienced an increase in tumor size.
Additionally, 16 of the 20 participants showed a decrease in CA19-9 levels, a tumor marker. Seven participants showed a reduction greater than 90%, including five patients from Cohort 3. Nine participants had a reduction of more than 50%, including six from Cohort 3.
“Given the highly promising preliminary data presented at ESMO-GI, which highlighted a 60% overall response rate and 100% overall disease control rate, we are even more optimistic about the potential impact of this therapy,” WARPNINE CEO Meg Croucher said.
“We look forward to analyzing the final data from the study and continuing our work to bring more effective treatments to those who need them most.”