Lisata Therapeutics Inc (NASDAQ:LSTA) and WARPNINE have announced promising preliminary results from their Phase 1b/2a iLSTA trial, which is evaluating Lisata's investigational drug certepetide in combination with standard-of-care chemotherapy and immunotherapy for locally advanced non-resectable pancreatic ductal adenocarcinoma (PDAC).
The iLSTA trial is being conducted at St John of God Subiaco Hospital in Western Australia, involving 30 patients divided into three treatment cohorts.
The study assesses the efficacy of certepetide alongside standard treatments such as nab-paclitaxel, gemcitabine, and durvalumab.
Of 17 patients, 9 achieved a partial response after four treatment cycles, and one exhibited a complete response.
14 of the 17 patients showed decreased CA19-9 levels, with six patients experiencing over 90% reduction.
Five patients had their repeat biopsies analyzed for tumor infiltrating lymphocytes, with all demonstrating significant immune cell infiltration, indicating a potential enhancement of the immune response against tumors.
Lisata highlighted that the results corroborate earlier preclinical findings suggesting that certepetide can enhance the effectiveness of immunotherapy, potentially overcoming challenges associated with PDAC's dense tumor microenvironment.
“These initial results from the iLSTA trial suggest that certepetide, when combined with SoC chemotherapy and immunotherapy, can positively impact treatment outcomes for patients with locally advanced non-resectable PDAC,” Lisata chief medical officer Dr Kristen Buck said in a statement.
“These encouraging findings not only validate certepetide's unique mechanism of action but also support our hypothesis that it can enhance the effectiveness of various cancer treatments, regardless of the modality of the co-administered therapies. The results also reinforce certepetide's potential to impact patients across the spectrum of pancreatic cancer.”
The preliminary data will be presented at the upcoming American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium on January 24.