The Independent Data Safety Monitoring Committee for the phase 2 ASCEND trial has given the okay to continue evaluation of LSTA1 for patients with pancreatic cancer.
LSTA1 in combination with standard-of-care (SOC) gemcitabine/nab-paclitaxel in patients with first-line, metastatic pancreatic ductal adenocarcinoma (mPDAC) has been given the green light to continue investiagation based on data from the prespecified interim futility analysis for the phase 2 ASCEND trial (NCT05042128).1
The study’s Independent Data Safety Monitoring Committee (IDSMC) reviewed results from the interim futility analysis and determined that the ASCEND trial should 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,” stated David J. Mazzo, PhD, president and chief executive officer of Lisata, in a press release “ASCEND continues to enroll at a rapid pace and we affirm our projection of the last patient in during the first half of 2024.”
LSTA1 is an investigational drug which activates a novel uptake pathway and allows co-administered anti-cancer drugs to penetrate solid tumors. The product also has the potential to modify the tumor microenvironment and aims to make tumors more susceptible to immunotherapies.
In clinical trials, LSTA1 has shown favorable safety, tolerability, and activity. LSTA1 has enhanced delivery of SOC chemotherapy for pancreatic cancer and now, the potential of LSTA1 to enable a variety of treatment modalities to treat a range of solid tumors is being investigated.
The double-blind, randomized, placebo-controlled, phase 2b ASCEND trial is evaluating LSTA1 in 155 patients with untreated, histologically confirmed metastatic pancreatic cancer who will be randomized in a 2:1 fashion. Patients must have measurable disease according to RECIST 1.1, archival tumour tissue for tertiary correlative studies, an ECOG performance status of 0-1, and adequate renal, hematologic, and hepatic function to enroll in the study.2
In the experimental arm of the study, patients will receive nab-paclitaxel at a dose of 125 mg/m2, LSTA1 3.2 mg/kg via intravenous infusion, and gemcitabine 1000mg/m2 on day 1, 8, and 15 of each 28-day cycle. Patients in the placebo arm will receive the same regimen, excluding treatment with LSTA1.
The primary end point of the study is progression-free survival with secondary end points of objective tumor response safety, overall survival, and patient reported outcomes.
The trial expects to complete enrollment by the first half of 2024. However, with the current enrollment already exceeding 80% of the target, earlier enrollment completion may be achieved.1