Lisata Therapeutics and WARPNINE Incorporated completed patient enrollment in their Phase 1b/2a iLSTA trial in Australia. The trial evaluates certepetide, combined with standard chemotherapy and immunotherapy, as a first-line treatment for locally advanced, unresectable pancreatic ductal adenocarcinoma (PDAC). This is the first study evaluating this combination therapy in locally advanced, unresectable PDAC, a less advanced stage than metastatic PDAC where immunotherapy has historically shown limited efficacy.
This trial is significant because it targets a patient population with limited effective treatment options. The preliminary data, showcasing promising response rates, suggests the potential for this combination therapy to meaningfully improve outcomes for individuals with locally advanced PDAC, a disease with a historically poor prognosis. The successful completion of enrollment underscores the collaborative effort between Lisata, WARPNINE, AstraZeneca, and St John of God Subiaco Hospital, highlighting the increasing importance of cross-sector partnerships in advancing cancer research.
The iLSTA trial enrolled patients into three cohorts: one receiving standard chemotherapy with placebo durvalumab and certepetide, another receiving chemotherapy plus certepetide and placebo durvalumab, and the largest cohort receiving the full combination of chemotherapy, durvalumab, and certepetide. Preliminary data from the ESMO-GI Congress revealed a 60% overall response rate and a 100% disease control rate after four treatment cycles. Notably, within the combination therapy cohort, 11 of 20 patients exhibited a partial response, and one patient achieved a complete response. Furthermore, significant reductions in CA19-9 levels, a biomarker for pancreatic cancer, were observed.
The promising preliminary data from the iLSTA trial suggest certepetide may improve treatment outcomes for locally advanced PDAC. Final data analysis will be critical for confirming these initial findings. If the final data remain positive, it could lead to a new treatment option for this patient population and pave the way for further research into certepetide’s potential applications in other cancers and treatment modalities. This could significantly impact the pancreatic cancer treatment landscape and potentially improve patient survival rates.
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.
