Lisata Therapeutics Reports Encouraging Preliminary Cohort A Data from the AGITG-led Phase 2 ASCEND Trial Evaluating Certepetide with Standard-of-Care Chemotherapy in Metastatic Pancreatic Ductal Adenocarcinoma
Lisata Therapeutics (NASDAQ: LSTA) announced preliminary Cohort A data from its Phase 2 ASCEND trial evaluating certepetide with standard chemotherapy in metastatic pancreatic ductal adenocarcinoma. The trial, conducted across 25 sites in Australia and New Zealand, showed encouraging results with a median overall survival of 12.68 months in the certepetide group versus 9.72 months in the placebo group.
The study reported 4 complete responses (6.2%) in the certepetide treatment group compared to none in the placebo group. While the 6-month progression-free survival showed a numerical trend favoring certepetide, both groups had a median PFS of 5.5 months. The trial includes two cohorts: Cohort A with 95 patients receiving a single dose, and Cohort B with 63 patients receiving two doses of certepetide. Data from Cohort B is expected in the coming months, with plans to advance to Phase 3 in early 2026.
Lisata Therapeutics (NASDAQ: LSTA) ha annunciato i dati preliminari del Coorte A del suo studio di Fase 2 ASCEND che valuta il certepetide in combinazione con la chemioterapia standard nel carcinoma pancreatico duttale metastatico. Lo studio, condotto in 25 centri in Australia e Nuova Zelanda, ha mostrato risultati incoraggianti con una sopravvivenza globale mediana di 12,68 mesi nel gruppo di trattamento con certepetide rispetto a 9,72 mesi nel gruppo placebo.
Lo studio ha riportato 4 risposte complete (6,2%) nel gruppo di trattamento con certepetide rispetto a nessuna nel gruppo placebo. Sebbene la sopravvivenza libera da progressione a 6 mesi mostrasse una tendenza numerica a favore del certepetide, entrambi i gruppi avevano una PFS mediana di 5,5 mesi. Lo studio include due coorti: la Coorte A con 95 pazienti che ricevono una dose singola e la Coorte B con 63 pazienti che ricevono due dosi di certepetide. I dati della Coorte B sono attesi nei prossimi mesi, con piani per avanzare alla Fase 3 all'inizio del 2026.
Lisata Therapeutics (NASDAQ: LSTA) anunció los datos preliminares del Cohorte A de su ensayo de Fase 2 ASCEND que evalúa el certepetide con quimioterapia estándar en adenocarcinoma ductal pancreático metastásico. El ensayo, realizado en 25 centros en Australia y Nueva Zelanda, mostró resultados alentadores con una supervivencia global mediana de 12,68 meses en el grupo de certepetide frente a 9,72 meses en el grupo placebo.
El estudio reportó 4 respuestas completas (6,2%) en el grupo de tratamiento con certepetide en comparación con ninguna en el grupo placebo. Si bien la supervivencia libre de progresión a 6 meses mostró una tendencia numérica favorable al certepetide, ambos grupos tuvieron una PFS mediana de 5,5 meses. El ensayo incluye dos cohortes: la Cohorte A con 95 pacientes que reciben una sola dosis y la Cohorte B con 63 pacientes que reciben dos dosis de certepetide. Se esperan los datos de la Cohorte B en los próximos meses, con planes de avanzar a la Fase 3 a principios de 2026.
리사타 테라퓨틱스 (NASDAQ: LSTA)는 전이성 췌장관 선암에서 표준 화학요법과 함께 세르테페타이드를 평가하는 2상 ASCEND 시험의 코호트 A에서 preliminary 데이터를 발표했습니다. 호주와 뉴질랜드의 25개 사이트에서 실시된 이 시험은 12.68개월의 중간 전체 생존 기간을 세르테페타이드 그룹에서 보여주었으며, 이는 위약 그룹의 9.72개월과 비교됩니다.
이 연구는 세르테페타이드 치료 그룹에서 4건의 완전 반응(6.2%)을 보고하였고, 위약 그룹에서는 없었습니다. 6개월 무진행 생존율은 세르테페타이드가 유리한 경향을 보였지만, 두 그룹 모두 중간 PFS는 5.5개월이었습니다. 이 시험은 한 번의 용량을 받는 95명의 환자가 있는 코호트 A와 두 번의 용량을 받는 63명의 환자가 있는 코호트 B의 두 코호트를 포함합니다. 코호트 B의 데이터는 향후 몇 개월 내에 발표될 예정이며, 2026년 초에 3상으로 진행할 계획입니다.
Lisata Therapeutics (NASDAQ: LSTA) a annoncé des données préliminaires concernant la Cohorte A de son essai de Phase 2 ASCEND évaluant le certepetide avec une chimiothérapie standard dans l'adénocarcinome canalaire pancréatique métastatique. L'essai, réalisé dans 25 sites en Australie et en Nouvelle-Zélande, a montré des résultats encourageants avec une survie globale médiane de 12,68 mois dans le groupe traitement au certepetide contre 9,72 mois dans le groupe placebo.
L'étude a rapporté 4 réponses complètes (6,2%) dans le groupe de traitement au certepetide contre aucune dans le groupe placebo. Bien que la survie sans progression à 6 mois ait montré une tendance numérique en faveur du certepetide, les deux groupes avaient une PFS médiane de 5,5 mois. L'essai comprend deux cohortes : la Cohorte A avec 95 patients recevant une dose unique, et la Cohorte B avec 63 patients recevant deux doses de certepetide. Les données de la Cohorte B sont attendues dans les mois à venir, avec des plans d'avancer en Phase 3 début 2026.
Lisata Therapeutics (NASDAQ: LSTA) hat vorläufige Daten der Kohorte A aus seiner Phase-2-Studie ASCEND veröffentlicht, die Certepetid in Kombination mit standardmäßiger Chemotherapie bei metastasiertem duktalem Pankreaskarzinom bewertet. Die Studie, die an 25 Standorten in Australien und Neuseeland durchgeführt wurde, zeigte ermutigende Ergebnisse mit einer mittleren Gesamtüberlebenszeit von 12,68 Monaten in der Certepetid-Gruppe im Vergleich zu 9,72 Monaten in der Placebo-Gruppe.
Die Studie berichtete von 4 vollständigen Therapien (6,2%) in der Certepetid-Behandlungsgruppe im Vergleich zu keiner im Placebo-Gruppe. Obwohl die 6-monatige progressionsfreie Überlebenszeit einen numerischen Trend zugunsten von Certepetid zeigte, hatten beide Gruppen eine mittlere PFS von 5,5 Monaten. Die Studie umfasst zwei Kohorten: Kohorte A mit 95 Patienten, die eine Einzeldosis erhalten, und Kohorte B mit 63 Patienten, die zwei Dosen Certepetid erhalten. Die Daten der Kohorte B werden in den kommenden Monaten erwartet, mit dem Plan, Anfang 2026 in die Phase 3 zu wechseln.
- Median overall survival increased by 3 months in certepetide group (12.68 vs 9.72 months)
- 4 complete responses (6.2%) achieved in certepetide group vs 0 in placebo
- Early indications suggest strong separation in median PFS for Cohort B
- No significant improvement in median PFS observed in Cohort A (5.5 months in both groups)
Insights
The preliminary Phase 2 ASCEND trial data for Lisata Therapeutics' certepetide represents a potentially meaningful development in the challenging landscape of pancreatic cancer treatment. The observed 2.96-month improvement in median overall survival (12.68 vs 9.72 months) warrants attention, particularly in a disease where survival gains are typically measured in weeks rather than months.
Most striking is the achievement of 4 complete responses in the treatment group compared to zero in placebo. To put this in perspective, complete responses in metastatic pancreatic cancer are extremely rare with current standard-of-care treatments. This suggests certepetide may be capable of producing durable responses in a subset of patients, though the specific biomarkers or characteristics of responding patients remain to be determined.
The dual-cohort design of ASCEND is strategically significant. While Cohort A tested a single dose regimen, Cohort B's two-dose approach (separated by 4 hours) could potentially enhance drug exposure and efficacy. Early indicators suggesting stronger progression-free survival separation in Cohort B could validate this hypothesis.
For investors, several key points merit attention: 1) The planned advancement to Phase 3 in early 2026 indicates management's confidence in the data 2) The trial's robust design, including double-blinding and placebo control, strengthens the reliability of results 3) The 25-site international study network demonstrates operational capability for larger trials 4) The collaboration with AGITG adds credibility and execution capability.
However, critical questions remain: Will the survival benefit maintain statistical significance in the final analysis? Can biomarkers identify patients most likely to achieve complete responses? Will Cohort B's modified dosing regimen demonstrate superior efficacy? These answers will be important for determining certepetide's ultimate commercial potential in the competitive oncology landscape.
Cohort A data to be presented in a poster session at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium
Data reported positive trend in overall survival, including 4 complete responses observed in the certepetide treatment group compared to none in placebo group
Data from Cohort B expected in the coming months, with full data from both cohorts to be reported thereafter
BASKING RIDGE, N.J., Jan. 22, 2025 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced preliminary Cohort A data from the ongoing Phase 2 ASCEND trial (NCT05042128) being conducted at 25 sites across Australia and New Zealand led by the Australasian Gastro-Intestinal Trials Group (AGITG) and coordinated by the National Health and Medical Research Council (NHMRC) Clinical Trial Centre at the University of Sydney. The data will be presented in a poster session, entitled, “AGITG ASCEND: Randomized, double-blind Phase II study of certepetide or placebo added to gemcitabine plus nab-paclitaxel in patients with untreated metastatic pancreatic ductal adenocarcinoma: Initial results,” at the 2025 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium on Friday, January 24th at 11:30 a.m. - 1:00 p.m. (PST) in San Franscisco, California. For a detailed summary of the poster presentation, please see the abstract available on the ASCO GI website: meetings.asco.org/abstracts-presentations/241497.
The Phase 2 double-blind, randomized (2:1 ratio), placebo-controlled trial is evaluating certepetide, Lisata's proprietary investigational iRGD cyclic peptide product candidate, in combination with standard-of-care (SoC) chemotherapy (gemcitabine and nab-paclitaxel) for the treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). Following the acquisition of Cend Therapeutics, Lisata collaborated with AGITG to amend the inherited trial’s protocol to ensure it respected international regulatory standards and was optimized to generate clinically meaningful data that would effectively guide the next stages of development. The amended protocol is designed to assess the efficacy of two different dosing regimens of certepetide in two separate treatment cohorts: Cohort A, with 95 patients receiving a single intravenous (IV) dose of certepetide 3.2 mg/kg or placebo in combination with SoC, and Cohort B, with 63 patients receiving two IV doses of certepetide 3.2 mg/kg or placebo administered 4 hours apart in combination with SoC.
Cohort A of the ASCEND trial completed enrollment in the third quarter of 2023. The preliminary data from Cohort A demonstrate a median overall survival (mOS) of 12.68 months for the certepetide treated group, compared to 9.72 months for the placebo treated group. Despite a numerical trend in 6-month PFS favoring the certepetide treatment group, no significant improvement in median PFS was observed (mPFS of 5.5 months in both groups). However, the observed mOS and objective response rate (ORR) benefit are positive with 4/65 (
“The data from Cohort A are as we expected and corroborate our decision to add Cohort B to the ASCEND protocol,” stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. “The increase in overall survival and the observation of 4 complete responses in the certepetide-treated group compared to none in the placebo group for Cohort A, coupled with our expectation of even better outcomes in Cohort B, where we believe early indications show a strong separation in mPFS benefiting patients treated with certepetide, support our plans to advance certepetide development to Phase 3 in early 2026.”
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 early 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. Learn more about certepetide’s mechanism of action in our short film. For more information on the Company, please visit www.lisata.com.
Forward-Looking Statements
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 metastatic pancreatic ductal adenocarcinoma and other solid tumors; 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 a single patient case study 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 29, 2024, 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.
Lisata Therapeutics Contact:
Investors:
Lisata Therapeutics
John Menditto
Vice President, Investor Relations and Corporate Communications
Phone: 908-842-0084
Email: jmenditto@lisata.com
Media:
ICR Healthcare
Elizabeth Coleman
Account Supervisor
Phone: 203-682-4783
Email: elizabeth.coleman@icrhealthcare.com
This press release was published by a CLEAR® Verified individual.
FAQ
What were the key results of LSTA's Phase 2 ASCEND trial Cohort A for pancreatic cancer?
How many complete responses did LSTA's certepetide achieve in the ASCEND trial?
When will LSTA release the full ASCEND trial results including Cohort B?
What is the difference between Cohort A and B in LSTA's ASCEND trial?
When does LSTA plan to advance certepetide to Phase 3 trials?
