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Positive Preliminary Cohort B Results from the AGITG-led ASCEND Trial to be Presented at ESMO GI Evaluating Lisata’s Certepetide in Combination with Standard-of-Care Chemotherapy in Metastatic Pancreatic Cancer

Core Insights - The ASCEND Phase 2b trial shows promising preliminary data for certepetide in treating metastatic pancreatic cancer, with positive signals in progression-free survival and objective response rates compared to placebo [1][2][6] - Cohort B data supports the findings from Cohort A, indicating a treatment effect and an attractive safety profile for certepetide [1][6][8] - Full study data from both cohorts is expected later this year, which may provide further insights into the efficacy of certepetide [7] Study Design and Results - The ASCEND trial is a double-blind, randomized, placebo-controlled study involving 158 patients, comparing standard-of-care gemcitabine and nab-paclitaxel with or without certepetide [3] - Cohort A utilized a single dose of 3.2 mg/kg of certepetide, while Cohort B included an additional dose administered four hours later [3] - Preliminary results from Cohort B indicate a six-month progression-free survival of 60.8% for the certepetide group versus 25% for the placebo group, with median progression-free survival of 7.5 months compared to 4.7 months [5] Clinical Significance - The addition of certepetide resulted in a clinically meaningful improvement in both progression-free survival and objective response rates for patients with metastatic pancreatic ductal adenocarcinoma [6] - The objective response rate was 45.2% for the certepetide group compared to 19% for the placebo group, and median overall survival was 10.32 months versus 9.23 months [5] Industry Context - Pancreatic cancer has a poor prognosis, being the sixth leading cause of cancer mortality globally, with a five-year survival rate of only 13%, highlighting the need for new treatment options [9] - Certepetide is designed to enhance the delivery of anti-cancer drugs to solid tumors and has shown favorable safety and tolerability in clinical trials [12][13]