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
Lisata Therapeutics (NASDAQ:LSTA) announced positive preliminary results from Cohort B of the ASCEND Phase 2b trial evaluating certepetide in metastatic pancreatic cancer. The trial, conducted across 24 sites in Australia and New Zealand, demonstrated significant improvements in patient outcomes.
Key findings include progression-free survival of 60.8% vs 25% (certepetide vs placebo), median progression-free survival of 7.5 vs 4.7 months, and objective response rate of 45.2% vs 19%. Median overall survival improved to 10.32 months vs 9.23 months. The Cohort B regimen, which added a second dose of certepetide, showed meaningful improvements compared to Cohort A's single-dose approach.
Final data from both cohorts is expected later this year, with results suggesting certepetide could potentially transform treatment for metastatic pancreatic cancer, which currently has a five-year survival rate of just 13%.
Lisata Therapeutics (NASDAQ:LSTA) ha annunciato risultati preliminari positivi dal Cohort B dello studio ASCEND di Fase 2b che valuta certepetide nel carcinoma pancreatico metastatico. Lo studio, condotto in 24 centri tra Australia e Nuova Zelanda, ha mostrato miglioramenti significativi negli esiti dei pazienti.
I risultati chiave includono una sopravvivenza libera da progressione del 60,8% contro il 25% (certepetide vs placebo), una sopravvivenza mediana libera da progressione di 7,5 mesi contro 4,7 mesi e un tasso di risposta obiettiva del 45,2% contro il 19%. La sopravvivenza globale mediana è migliorata a 10,32 mesi contro 9,23 mesi. Il regime del Cohort B, che prevedeva una seconda dose di certepetide, ha mostrato miglioramenti significativi rispetto all'approccio a dose singola del Cohort A.
I dati finali di entrambi i cohort sono attesi entro la fine dell'anno, con risultati che suggeriscono come certepetide potrebbe rivoluzionare il trattamento del carcinoma pancreatico metastatico, che attualmente ha un tasso di sopravvivenza a cinque anni del solo 13%.
Lisata Therapeutics (NASDAQ:LSTA) anunció resultados preliminares positivos del Cohorte B del ensayo ASCEND de fase 2b que evalúa certepetide en cáncer pancreático metastásico. El estudio, realizado en 24 centros de Australia y Nueva Zelanda, mostró mejoras significativas en los resultados de los pacientes.
Los hallazgos clave incluyen una supervivencia libre de progresión del 60,8% frente al 25% (certepetide vs placebo), una supervivencia libre de progresión mediana de 7,5 frente a 4,7 meses y una tasa de respuesta objetiva del 45,2% frente al 19%. La supervivencia global mediana mejoró a 10,32 meses frente a 9,23 meses. El régimen del Cohorte B, que añadió una segunda dosis de certepetide, mostró mejoras significativas en comparación con el enfoque de dosis única del Cohorte A.
Se esperan los datos finales de ambos cohortes a finales de este año, con resultados que sugieren que certepetide podría transformar potencialmente el tratamiento del cáncer pancreático metastásico, que actualmente tiene una tasa de supervivencia a cinco años de solo el 13%.
Lisata Therapeutics (NASDAQ:LSTA)는 전이성 췌장암에서 certepetide를 평가하는 ASCEND 2b상 시험의 코호트 B에서 긍정적인 예비 결과를 발표했습니다. 호주와 뉴질랜드 24개 사이트에서 진행된 이번 시험은 환자 결과에서 유의미한 개선을 보여주었습니다.
주요 결과로는 무진행 생존율이 60.8% 대 25% (certepetide 대 위약), 중간 무진행 생존기간이 7.5개월 대 4.7개월, 그리고 객관적 반응률이 45.2% 대 19%로 나타났습니다. 전체 생존 중간값도 10.32개월 대 9.23개월로 향상되었습니다. 코호트 B의 치료법은 두 번째 certepetide 투여를 추가하여, 코호트 A의 단일 투여 방식보다 의미 있는 개선을 보였습니다.
양 코호트의 최종 데이터는 올해 말에 발표될 예정이며, 이번 결과는 현재 5년 생존율이 13%에 불과한 전이성 췌장암 치료에 certepetide가 잠재적으로 혁신을 가져올 수 있음을 시사합니다.
Lisata Therapeutics (NASDAQ:LSTA) a annoncé des résultats préliminaires positifs du Cohorte B de l'essai ASCEND de phase 2b évaluant certepetide dans le cancer du pancréas métastatique. L'essai, mené dans 24 centres en Australie et en Nouvelle-Zélande, a démontré des améliorations significatives des résultats pour les patients.
Les résultats clés incluent une survie sans progression de 60,8 % contre 25 % (certepetide vs placebo), une survie médiane sans progression de 7,5 contre 4,7 mois, et un taux de réponse objective de 45,2 % contre 19 %. La survie globale médiane s'est améliorée à 10,32 mois contre 9,23 mois. Le schéma du Cohorte B, qui a ajouté une seconde dose de certepetide, a montré des améliorations significatives par rapport à l'approche à dose unique du Cohorte A.
Les données finales des deux cohortes sont attendues plus tard cette année, les résultats suggérant que certepetide pourrait potentiellement transformer le traitement du cancer du pancréas métastatique, qui présente actuellement un taux de survie à cinq ans de seulement 13 %.
Lisata Therapeutics (NASDAQ:LSTA) gab positive vorläufige Ergebnisse aus Kohorte B der ASCEND Phase 2b-Studie bekannt, die certepetide bei metastasiertem Bauchspeicheldrüsenkrebs untersucht. Die Studie, die an 24 Standorten in Australien und Neuseeland durchgeführt wurde, zeigte signifikante Verbesserungen bei den Patientenergebnissen.
Wesentliche Ergebnisse umfassen eine progressionsfreie Überlebensrate von 60,8 % gegenüber 25 % (certepetide vs. Placebo), eine median progressionsfreie Überlebenszeit von 7,5 gegenüber 4,7 Monaten und eine objektive Ansprechrate von 45,2 % gegenüber 19 %. Das mediane Gesamtüberleben verbesserte sich auf 10,32 Monate gegenüber 9,23 Monaten. Das Regime der Kohorte B, das eine zweite Dosis certepetide hinzufügte, zeigte im Vergleich zum Einzeldosisansatz der Kohorte A bedeutende Verbesserungen.
Die endgültigen Daten beider Kohorten werden später in diesem Jahr erwartet, wobei die Ergebnisse darauf hindeuten, dass certepetide die Behandlung des metastasierten Bauchspeicheldrüsenkrebses, der derzeit eine Fünf-Jahres-Überlebensrate von nur 13 % aufweist, potenziell revolutionieren könnte.
- Significant improvement in 6-month progression-free survival (60.8% vs 25%) for certepetide group
- Higher objective response rate of 45.2% vs 19% in placebo group
- Improved median progression-free survival of 7.5 months vs 4.7 months
- Attractive safety profile demonstrated across both cohorts
- Two-dose regimen (Cohort B) showed better results than single-dose (Cohort A)
- Modest improvement in median overall survival (10.32 vs 9.23 months)
- Full study data still pending, creating uncertainty about final outcomes
Insights
Lisata's certepetide shows promising Phase 2b results in metastatic pancreatic cancer with improved progression-free survival and response rates.
The preliminary Cohort B data from the ASCEND trial demonstrates significant clinical benefits for certepetide when combined with standard chemotherapy in metastatic pancreatic ductal adenocarcinoma (mPDAC). Most notably, the certepetide-treated group achieved a six-month progression-free survival rate of 60.8% compared to just 25% in the placebo group – a substantial difference in a disease with historically poor outcomes.
The median progression-free survival showed a 2.8-month improvement (7.5 vs. 4.7 months), while the objective response rate more than doubled from 19% to 45.2% with certepetide. These metrics are particularly meaningful in pancreatic cancer, where response rates to traditional therapies have been notoriously low.
What's especially encouraging is that the Cohort B dosing regimen (adding a second certepetide dose 4 hours after the initial dose) appears to enhance efficacy compared to the single-dose approach used in Cohort A. This suggests a dose-response relationship that could guide optimal treatment protocols.
The overall survival data shows a modest improvement (10.32 vs. 9.23 months), but progression-free survival and response rate improvements are more substantial. In the context of pancreatic cancer – which has a 5-year survival rate of just 13% – these improvements represent meaningful clinical progress.
Importantly, these results corroborate earlier findings from Cohort A (which reported complete responses in four certepetide-treated patients), strengthening the evidence for certepetide's efficacy. The consistency across cohorts, combined with the reported "attractive safety profile," positions this therapy as a potentially significant advancement in treating one of oncology's most challenging cancers.
ASCEND comprises two dosing regimens of certepetide evaluated in two separate study arms enrolled sequentially
Positive signal in progression-free survival and objective response rate observed in certepetide-treated group compared to placebo-treated group
Cohort B data corroborate Cohort A data indicating certepetide has a treatment effect and an attractive safety profile
Full study data from both cohorts expected later this year
BARCELONA, Spain, June 26, 2025 (GLOBE NEWSWIRE) -- The Australasian Gastro-Intestinal Trials Group (“AGITG”), the NHMRC Clinical Trials Centre at the University of Sydney, and Lisata Therapeutics, Inc (“Lisata”, Nasdaq: LSTA), today announced promising positive preliminary Cohort B data from the ASCEND Phase 2b trial (NCT05042128) in metastatic pancreatic cancer, with AGITG sponsoring the study and Lisata providing funding. Dr. Andrew Dean, Study Chair, is scheduled to present these findings at the European Society for Medical Oncology (“ESMO”) Gastrointestinal Cancers Congress in Barcelona, Spain, on 2 July, 2025.
The ASCEND trial is a 158-patient, double-blind, randomized, placebo-controlled Phase 2b clinical trial evaluating standard-of-care (“SoC”) gemcitabine and nab-paclitaxel vs SoC plus certepetide or placebo in patients with metastatic pancreatic ductal adenocarcinoma (“mPDAC”). Participants were enrolled from 24 sites across Australia and Aotearoa New Zealand from May 2022 to December 2023. The study comprises two sequentially enrolled dosing regimens of either certepetide or placebo in combination with SoC. Cohort A employed one 3.2 mg/kg dose of certepetide administered as an IV push over 1 minute immediately after the infusion of gemcitabine and before the infusion of nab-paclitaxel. Cohort B mimicked the dosing regimen of Cohort A; however, it employed an additional dose of certepetide or placebo administered 4 hours after the initial dose.
As announced in January of this year, preliminary Cohort A data was presented at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium. Those data showed a positive trend in overall survival, including four complete responses in the certepetide-treated group compared to none in the placebo-treated group.
The preliminary data from Cohort B demonstrate a six-month progression-free survival (“6MPFS”) of
A comparison of data from Cohort A and Cohort B indicates that the addition of two doses of certepetide (Cohort B regimen) to SoC chemotherapy resulted in a clinically meaningful improvement in both PFS and ORR for patients with mPDAC. These clinically significant findings provide compelling support for the continued and expedited investigation of certepetide as a novel therapeutic agent for the treatment of metastatic pancreatic cancer.
Final data and key findings from both cohorts of the ASCEND study are anticipated to be available later this year, with more information to follow as it becomes available.
“We are pleased with the promising Cohort B data of the ASCEND trial. These data, taken with those previously reported for Cohort A, reinforce our confidence in the therapeutic promise of certepetide. Along with its attractive safety profile, we continue to believe that certepetide has the potential to transform the treatment landscape for mPDAC and many other devastating solid tumors”, stated David J. Mazzo, PhD, President and Chief Executive Officer of Lisata.
Pancreatic cancer has one of the poorest prognoses among cancers, ranking as the 6th leading cause of cancer mortality worldwide1. In Australia, pancreatic cancer is the 3rd leading cause of cancer-related deaths2. With a five-year survival rate of just
Dr. Dean commented, “The data from ASCEND provides us with critical new knowledge that will significantly enhance our understanding of how to optimally treat patients battling pancreatic cancer. We are excited by the evidence of certepetide’s therapeutic effect and encourage the continued development of this potentially treatment paradigm-changing compound.”
We thank the Gut Cancer Foundation for providing funding for trial sites in Aotearoa New Zealand.
1. Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229–63.
2. Australian Institute of Health and Welfare (2024) Cancer data in Australia, AIHW, Australian Government, accessed 13 May 2025.
About Certepetide
Certepetide (formerly LSTA1), an internalizing RGD (arginylglycylaspartic acid or iRGD), cyclic peptide product candidate, 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. Certepetide 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. Certepetide also has been shown to modify the tumor microenvironment resulting in tumors which are more susceptible to immunotherapies. We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer. Lisata is exploring the potential of certepetide to enable a variety of treatment modalities to treat a range of solid tumors more effectively. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma (U.S.) and osteosarcoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.).
About Lisata Therapeutics
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 cyclic peptide product candidate, certepetide, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to selectively target and penetrate solid tumors more effectively. Lisata has already established noteworthy commercial and R&D partnerships based on its CendR Platform® technology. The Company expects to announce numerous milestones over the next 1.5 years and believes that its projected capital will fund operations into the fourth quarter of 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. For a comprehensive overview of certepetide's mechanism of action, please view our informative short film. For more information on the Company, please visit www.lisata.com.
About the Australasian Gastro-Intestinal Trials Group (AGITG)
The 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 90 GI cancer research studies, enrolling 9,900 patients across 287 sites worldwide. Learn more.
About the NHMRC Clinical Trials Centre, University of Sydney
The NHMRC Clinical Trials Centre is a flagship research centre at the University of Sydney that designs and coordinates clinical trials. This includes responsibility for study coordination, monitoring, data acquisition and management and statistical analysis. Over the past 35 years the NHMRC Clinical Trials Centre has co-led more than 150 clinicals trials involving over 100,000 patients which have changed global clinical practice. It also undertakes work in health economics, biostatistics, systematic reviews and biomarker research that can help inform healthcare providers about best practice. Learn more.
Forward-Looking Statements (Lisata related)
This communication contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding the Company’s clinical development programs are forward-looking statements. In addition, when or if used in this communication, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Lisata or its management, may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, the potential efficacy of certepetide as a treatment for patients with solid tumors; our beliefs about the potential uses and benefits of certepetide; statements relating to Lisata’s continued listing on the Nasdaq Capital Market; expectations regarding the capitalization, resources and ownership structure of Lisata; the approach Lisata is taking to discover and develop novel therapeutics; the adequacy of Lisata’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; and the difficulty in predicting the time and cost of development of Lisata’s product candidates. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: results observed from preliminary data are not necessarily indicative of final results and one or more of the clinical outcomes may materially change following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the safety and efficacy of Lisata’s product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in Lisata’s clinical programs, Lisata’s ability to finance its operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of Lisata’s scientific studies, Lisata’s ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in Lisata’s markets, the ability of Lisata to protect its intellectual property rights; and legislative, regulatory, political and economic developments. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Lisata’s Annual Report on Form 10-K filed with the SEC on February 27, 2025, and in other documents filed by Lisata with the Securities and Exchange Commission. Except as required by applicable law, Lisata undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events, or otherwise.
Contact:
Lisata Therapeutics (Investors):
John Menditto
Vice President, Investor Relations and Corporate Communications
Email: jmenditto@lisata.com
Phone: 908-842-0084
Lisata Therapeutics (Media):
ICR Healthcare
Elizabeth Coleman
Account Supervisor
Phone: 203-682-4783
Email: elizabeth.coleman@icrhealthcare.com
AGITG
Erin Burgess, Head of Communications
Email: erin@gicancer.org.au
Mobile: 0402 152 592
NHMRC CTC, University of Sydney
University of Sydney Media Office
Email: media.office@sydney.edu.au
This press release was published by a CLEAR® Verified individual.
FAQ
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