Lisata Therapeutics Inc (NASDAQ:LSTA) joined Proactive to discuss the latest updates from the compay's pancreatic cancer trials.
The company recently announced preliminary results from its Phase 2ASCEND trial at the ASCO Gastrointestinal conference. Data from the randomized, double-blind, placebo-controlled cohort A group demonstrated promising trends in overall survival and efficacy.
In addition, Lisata released preliminary data from its iLSTA trial, which examines combining certepetide with immunotherapy (durvalumab) and cytotoxics for pancreatic cancer. The CEO highlighted increased T-cell tumor penetration and higher partial response rates in the early data, suggesting potential for enhanced treatment outcomes.
Proactive: Hello, you're watching Proactive. I'm joined by Lisata Therapeutics CEO David Mazzo. David, very good to speak with you again. You're out with preliminary data from your phase two pancreatic cancer trial. Are you encouraged by what it reveals?
David Mazzo: It's always a pleasure to be here. Thank you again. Yes. Our ASCEND trial announced preliminary data at the ASCO Gastrointestinal (GI) conference in San Francisco. And I will say this: it is exactly what we had expected. It shows very strong trends in endpoints of efficacy that are very important for future developments.
Specifically, there’s a strong trend in the improvement in overall survival of patients who were treated with certepetide and cytotoxics. In this randomized, double-blind, placebo-controlled cohort A group, which included 95 patients with 2:1 randomization—about 63 were on certepetide and standard of care, and the rest were on standard of care alone—we saw four complete responses in the certepetide group and zero in the standard of care group.
This is significant. For example, in the NAPOLI-3 trial, which was the phase three trial used to gain FDA approval for NALIRIFOX in pancreatic cancer, there was one complete response out of almost 400 patients. So, having four out of 63 is very promising. This all leads us to great anticipation for the cohort B aspect of the trial, which is expected to report over the next several months.
So, David, tell us what the cohort B trial entails compared to the cohort A trial.
Sure. When we acquired ASCEND Therapeutics and certepetide, the ASCEND trial was already underway. After reviewing the protocol, we realized it was missing some important drug developer information, not just academic data. We amended the trial to include overall survival endpoints, which is a key regulatory focus.
We also added cohort B. Cohort A is a single dose of certepetide combined with cytotoxics. Cohort B, however, introduces a second dose of certepetide, administered four hours after the first. The idea is to better understand certepetide’s pharmacodynamics and optimize efficacy. If the transport pathway isn’t open beyond four hours, a second dose could reopen it, allowing more effective delivery of the co-administered cytotoxics.
This amendment was made near the completion of cohort A’s enrollment, so the two cohorts were enrolled sequentially. That’s why cohort A data is available first, with cohort B results expected soon.
Moving away from the ASCEND trial for a moment, David, you've just released preliminary results from your iLSTA trial. Could you take us through the iLSTA trial and what that's targeting?
Sure. iLSTA is being conducted with WARPNINE, a foundation in Australia. They’ve been generous in funding the trial and collaborating on the protocol. The trial explores whether certepetide can enhance the efficacy of cytotoxics in combination with immunotherapy—in this case, durvalumab.
Checkpoint inhibitors and immunotherapy historically haven’t been effective against pancreatic cancer. This trial focuses on locally advanced, non-resectable pancreatic cancer. It examines combinations of standard care, durvalumab, certepetide, and all three together.
The first 17 patients' data, presented at ASCO GI, showed that the combination of certepetide, durvalumab, and cytotoxics resulted in higher partial response rates early in treatment. Tumor biopsies also revealed increased infiltration of cytotoxic T cells in the presence of certepetide. This supports our preclinical findings and certepetide’s mechanism of action.
Quotes have been lightly edited for clarity and style