Lisata Therapeutics Announces Outcome of Interim Futility Analysis for its Phase 2b ASCEND Trial  in Metastatic Pancreatic Ductal Adenocarcinoma

Lisata Therapeutics, Inc. recently announced a positive outcome of the prespecified interim futility analysis for the ASCEND trial, a Phase 2b study evaluating LSTA1, Lisata’s lead investigational product, in combination with standard-of-care (SOC) gemcitabine/nab-paclitaxel in patients with first-line, metastatic pancreatic ductal adenocarcinoma (mPDAC). Based on the results of the interim futility analysis, which was reviewed by the study’s Independent Data Safety Monitoring Committee (IDSMC), the ASCEND trial will continue as planned without modification.

“We are pleased that the IDSMC has recommended that we continue the ASCEND trial without change and we see this as an indication of LSTA1’s potential to improve outcomes for patients and its acceptable safety profile,” said David J. Mazzo, PhD, President and Chief Executive Officer of Lisata. “ASCEND continues to enroll at a rapid pace and we affirm our projection of last patient in during the first half of 2024.”

The ASCEND trial is a 155-patient, double-blind, randomized, placebo-controlled Phase 2b clinical trial being conducted at up to 40 sites in Australia and New Zealand, led by the Australasian Gastro-Intestinal Trials Group (AGITG) in collaboration with the University of Sydney and with the National Health and Medical Research Council (NHMRC) Clinical Trial Centre at the University of Sydney as the Coordinating Centre. The trial is fully funded by Lisata through an unrestricted research support agreement. The trial is approved by the Sydney Local Health District (SLHD) Ethics Review Committee (Royal Prince Alfred Hospital Zone) (2021/ETH00985). ASCEND, based upon Cohort A (the group receiving a single dose of LSTA1 plus SOC), has 80% power with 95% confidence to detect a 16% increase in the 6-month progression free survival rate in the experimental arm vs. the control arm (SOC + placebo). Trial enrollment completion is projected for the first half of 2024; however, current enrollment already exceeds 80% of the target, so earlier enrollment completion may be achieved.

LSTA1 is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered (ie, covalently bound) anti-cancer drugs to penetrate solid tumors more effectively. LSTA1 actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. LSTA1 also has the potential to modify the tumor microenvironment, with the objective of making tumors more susceptible to immunotherapies. Lisata and its collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of existing and emerging anti-cancer therapies, including chemotherapeutics, immunotherapies and RNA-based therapeutics. Additionally, LSTA1 has demonstrated favorable safety, tolerability and activity in clinical trials to enhance delivery of SOC chemotherapy for pancreatic cancer. Lisata is exploring the potential of LSTA1 to enable a variety of treatment modalities to treat a range of solid tumors more effectively.

Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s lead product candidate, LSTA1, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. Based on Lisata’s CendR Platform Technology, Lisata has already established noteworthy commercial and R&D partnerships. The company expects to announce numerous clinical study and business milestones over the next two years and has projected that its current business and development plan is funded with available capital through these milestones and into early 2026. For more information, visit www.lisata.com.

The Australasian Gastro-Intestinal Trials Group (AGITG) is a multi-disciplinary collaborative group that undertakes patient-centric research to advance medical care and practice in the treatment of gastro-intestinal cancer. Since 1991, the AGITG has led 74 GI cancer clinical trials, enrolling 8,800 patients across 129 hospitals in Australia and New Zealand, and 125 sites globally. Learn more

As Australia’s first university – founded in 1850 – the University of Sydney has a proud history of global leadership in education and research and inspiring people from all backgrounds to contribute to positive real-world change. The University of Sydney is a world-renowned teaching and research institution – our research combines the expertise and talents of scholars from many disciplines. Learn more

Based at the University of Sydney, the NHMRC Clinical Trials Centre designs and manages clinical trials. This includes responsibility for study coordination, monitoring, data acquisition and management and statistical analysis. The NHMRC Clinical Trials Centre has health economics, biostatistics, systematic reviews and biomarker teams work with trial data and inform healthcare providers about best practice. Learn more