Lisata Therapeutics reports encouraging data from ASCEND Cohort B evaluating certepetide in pancreatic cancer

Lisata Therapeutics (NASDAQ:LSTA) announced encouraging preliminary results from Cohort B of its ASCEND Phase 2b clinical trial, evaluating certepetide in combination with standard-of-care chemotherapy for metastatic pancreatic ductal adenocarcinoma (mPDAC). The data showed a 6-month progression-free survival rate of 60.8% for the certepetide group compared to 25% for placebo, alongside an objective response rate of 45.2% versus 19%. These findings, building on positive Cohort A results and suggesting enhanced efficacy with a second dose, reinforce confidence in certepetide's potential to significantly improve patient outcomes and transform the mPDAC treatment landscape while maintaining a favorable safety profile.

Analysis

Lisata Therapeutics has reported highly encouraging preliminary data from Cohort B of its ASCEND Phase 2b trial for certepetide in metastatic pancreatic ductal adenocarcinoma (mPDAC). The results show a substantial clinical benefit, with a six-month progression-free survival (PFS) rate of 60.8% in the certepetide arm compared to just 25% in the placebo group. This was supported by a median PFS of 7.5 months versus 4.7 months and an objective response rate (ORR) more than doubling to 45.2% from 19%. While the median overall survival (OS) improvement was more modest at 10.32 months versus 9.23 months, the collective data, particularly the strong PFS and ORR figures, significantly strengthens the therapeutic case for certepetide. The comparison with the earlier Cohort A suggests that a second dose of the drug enhances efficacy without compromising its favorable safety profile. These findings represent a significant positive development for the asset, positioning it as a potentially transformative treatment in a notoriously difficult-to-treat cancer, pending final data later in 2025.

Key Decisions for Investors

• Given the statistically significant improvements in progression-free survival and objective response rate, these preliminary Phase 2b results should be viewed as a major positive catalyst and a significant de-risking event for the certepetide program.
• Investors should monitor the final, consolidated data from both cohorts, expected later in 2025, with a specific focus on whether the overall survival benefit matures and becomes more pronounced, as this will be a critical determinant for regulatory approval and commercial adoption.
• The upcoming presentation at the European Society for Medical Oncology Gastrointestinal Cancers Congress on July 2 is a key near-term event that could provide further details or subgroup analyses, potentially influencing short-term stock performance.