Combination treatment shows promise for pancreatic cancer PDAC
Clinical trial now testing certepetide plus standard-of-care therapies
Treatment with certepetide in combination with standard therapies led to stable disease in most people with a type of pancreatic cancer known as PDAC — fully, pancreatic ductal adenocarcinoma — in a clinical trial in Australia.
That’s according to new data from that Phase 1b/2a trial, called iLSTA, announced by certepetide’s developer Lisata Therapeutics.
“These initial results from the iLSTA trial suggest that certepetide, when combined with [standard-of-care] chemotherapy and immunotherapy, can positively impact treatment outcomes for patients with locally advanced nonresectable PDAC,” Kristen K. Buck, MD, executive vice president of research and development and chief medical officer of Lisata, said in a company press release.
Buck, who called the study’s findings to date “encouraging,” noted that “this patient population has historically demonstrated limited response to immunotherapy alone.”
According to Buck, the results “support our hypothesis that [certepetide] can enhance the effectiveness of various cancer treatments, regardless of the modality of the coadministered therapies.”
Detailed findings from the study are being presented today at the 2025 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium in California, in a poster titled “Immunotherapy engagement in pancreatic adenocarcinoma: Provisional results of iLSTA study— Durvalumab, LSTA1 (certepetide), gemcitabine, and nab-paclitaxel for locally advanced pancreatic ductal adenocarcinoma.”
Treatment designed for pancreatic cancer not treatable with surgery
Certepetide, formerly called LSTA1, is designed to activate cellular uptake pathways in cancer cells. By activating these pathways, the therapy aims to make it easier for other anticancer drugs to get into the cancer cells, thereby boosting the efficacy of other medicines.
The ongoing clinical trial (ACTRN12623000223639) enrolled 30 people with PDAC at a center in western Australia. All of the patients had advanced, unresectable cancer, meaning the tumor was not able to be cut out surgically.
Most of the participants were given certepetide in combination with a standard chemotherapy regimen (nab-paclitaxel and gemcitabine) and an immunotherapy drug called durvalumab (sold as Imfinzi). A few patients were given a placebo instead of durvalumab, with some also receiving a placebo instead of certepetide. The treatments were given in fixed days along a monthlong cycle.
The results showed that, among 17 evaluable patients, six showed a partial response — specifically, their tumors got smaller — after two cycles of treatment. All but one of these six patients had received active certepetide and durvalumab. All of the remaining 11 evaluable patients had stable disease, meaning their tumors didn’t grow any larger but also didn’t shrink.
After four cycles of treatment, 10 patients, nine of whom had received active certepetide and durvalumab, had a partial response. Among the other six, five had stable disease and one had a complete response, meaning the tumor effectively disappeared. The patient with the complete response had received active certepetide and chemotherapy, but was given the placebo instead of durvalumab.
Clinical trial sponsored by Australian nonprofit focused on rare cancer
Analyses of available tumor biopsies suggested that most patients had prominent infiltration of cancer-killing immune cells called lymphocytes, and no unexpected safety issues were noted.
Overall, according to the release, these findings “corroborate previously reported preclinical data demonstrating certepetide’s ability to enhance the effectiveness of immunotherapy.”
The data are being presented in a session today at the ASCO GI Cancers Symposium in San Francisco.
“The preliminary results of this study suggest that the combination of gemcitabine and nab-paclitaxel with [certepetide] and durvalumab is safe and potentially induces [tumor] infiltrating lymphocytes … in locally advanced pancreatic adenocarcinomas,” the researchers wrote in the poster abstract.
[These data] validate certepetide’s unique mechanism of action. … The results also reinforce certepetide’s potential to impact patients across the spectrum of pancreatic cancer.
Buck said these data “validate certepetide’s unique mechanism of action,” adding that “the results also reinforce certepetide’s potential to impact patients across the spectrum of pancreatic cancer.”
The clinical trial was sponsored by Warpnine, an Australian nonprofit focused on rare cancers like pancreatic cancer.
“The preliminary results from the iLSTA trial underscore the importance of collaborative efforts in addressing the unmet needs of patients with pancreatic cancer,” said Meg Croucher, CEO of Warpnine. The nonprofit was established by a group of cancer specialists.
“At Warpnine, we are dedicated to supporting innovative trials like iLSTA that push the boundaries of treatment possibilities and offer hope to those battling these aggressive malignancies,” Croucher said. “We look forward to continuing our work with Lisata Therapeutics to advance outcomes for patients.”
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