Lisata Therapeutics, Inc. (NASDAQ:LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced treatment of the first patient in the cholangiocarcinoma cohort of the BOLSTER Trial by Dr. Ian Hu, a principal investigator of the study, at The University of Texas MD Anderson Cancer Center in Houston, Texas. The Company had previously announced the first patient in the head and neck squamous cell carcinoma cohort of the study had been treated.
The BOLSTER trial is a Phase 2a, double-blind, placebo-controlled, multi-center, randomized study evaluating LSTA1 when added to standard-of-care (“SOC”) versus SOC alone in patients with either advanced second-line head and neck squamous cell carcinoma, second-line esophageal squamous cell carcinoma, or first-line cholangiocarcinoma. The BOLSTER trial is a basket trial being conducted at approximately 40 sites in North America, Europe, and Asia-Pacific. Total trial enrollment of 120 patients is expected to be completed in the second half of 2024. A “basket” trial is a trial in which a product (e.g., LSTA1) is tested in multiple indications sharing a similar trait or challenge (e.g., dense stroma in solid tumors) in separate arms of the study. The individual arms are enrolled and analyzed independently but share operational synergies such that the study is more efficient to execute than would be for conducting independent studies for each indication. Each arm of the BOLSTER trial will enroll 40 patients: 20 randomized to LSTA1 in combination with SOC and 20 randomized to placebo in combination with SOC.
“We are excited to announce treatment of the first patient in the cholangiocarcinoma cohort of the BOLSTER trial. Cholangiocarcinoma, or bile duct cancer, is a rare and aggressive cancer that often presents with minimal or no symptoms and, therefore, is often diagnosed in its very late stages. Even if diagnosed early, the 5-year survival rate is <25%. Unfortunately, most patients are diagnosed at a much later stage of disease progression and thus have a 5-year survival prognosis nearing 0%. Our hope is that LSTA1 will demonstrate a marked improvement in the efficacy of standard-of-care therapy for this insidious disease. As we have stated previously, the BOLSTER trial gives us the opportunity to evaluate the potential of LSTA1 in a variety of solid tumor settings in combination with corresponding standards-of-care and will provide direction on possible next steps in development,” stated Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer of Lisata. “With several patients already consented, enrolled, and treated in the study thus far, we are very pleased with its progress to date. We remain committed to developing groundbreaking therapies that can transform the outcomes of individuals facing these life-threatening conditions.”
For more information on the BOLSTER trial, please visit ClinicalTrials.gov (Identifier: NCT05712356).
