Actuate Therapeutics Highlights Significant and Sustained Survival Benefit in Key Metastatic Pancreatic Cancer Patient Populations in Phase 2 Elraglusib Trial
Actuate Therapeutics (NASDAQ: ACTU) reported significant results from its Phase 2 trial of elraglusib combined with gemcitabine/nab-paclitaxel (GnP) for metastatic pancreatic cancer treatment. Patients receiving at least one cycle showed improved median overall survival of 12.5 months vs 8.5 months in the control group, with a 43% reduction in death risk.
The trial demonstrated enhanced outcomes with elraglusib/GnP combination, including disease control rate of 53.4% vs 44.8% and overall response rate of 37.9% vs 29.3%. Notably, patients with liver metastases experienced a 2.5-fold increase in 1-year overall survival and 38% reduced death risk compared to control, with 13.6% survival probability at 18 months versus 0% in the control group.
Actuate Therapeutics (NASDAQ: ACTU) ha riportato risultati significativi dal suo trial di Fase 2 sull'elraglusib in combinazione con gemcitabina/nab-paclitaxel (GnP) per il trattamento del cancro pancreatico metastatico. I pazienti che hanno ricevuto almeno un ciclo hanno mostrato una sopravvivenza mediana complessiva migliorata di 12,5 mesi contro 8,5 mesi nel gruppo di controllo, con una riduzione del rischio di morte del 43%.
Lo studio ha evidenziato risultati migliori con la combinazione elraglusib/GnP, inclusi un tasso di controllo della malattia del 53,4% contro il 44,8% e un tasso di risposta complessiva del 37,9% contro il 29,3%. In particolare, i pazienti con metastasi epatiche hanno registrato un aumento di 2,5 volte della sopravvivenza complessiva a 1 anno e un rischio di morte ridotto del 38% rispetto al gruppo di controllo, con una probabilità di sopravvivenza del 13,6% a 18 mesi contro lo 0% nel gruppo di controllo.
Actuate Therapeutics (NASDAQ: ACTU) reportó resultados significativos de su ensayo de Fase 2 con elraglusib combinado con gemcitabina/nab-paclitaxel (GnP) para el tratamiento del cáncer pancreático metastásico. Los pacientes que recibieron al menos un ciclo mostraron una supervivencia global mediana mejorada de 12.5 meses frente a 8.5 meses en el grupo de control, con una reducción del 43% en el riesgo de muerte.
El ensayo demostró mejores resultados con la combinación elraglusib/GnP, incluyendo una tasa de control de la enfermedad del 53.4% frente al 44.8% y una tasa de respuesta global del 37.9% frente al 29.3%. Destaca que los pacientes con metástasis hepáticas experimentaron un aumento de 2.5 veces en la supervivencia global a 1 año y una reducción del 38% en el riesgo de muerte en comparación con el control, con una probabilidad de supervivencia del 13.6% a los 18 meses frente al 0% en el grupo de control.
Actuate Therapeutics (NASDAQ: ACTU)는 전이성 췌장암 치료를 위한 엘라글루시브(elraglusib)와 젬시타빈/납-파클리탁셀(GnP) 병용 요법의 2상 임상 시험에서 중요한 결과를 보고했습니다. 최소 한 사이클을 받은 환자들은 대조군의 8.5개월과 비교해 중앙 생존 기간이 12.5개월로 개선되었으며, 사망 위험이 43% 감소했습니다.
이 임상 시험은 엘라글루시브/GnP 병용 요법에서 향상된 결과를 보여주었으며, 질병 조절률이 53.4% 대 44.8%, 전체 반응률이 37.9% 대 29.3%로 나타났습니다. 특히 간 전이가 있는 환자들은 대조군에 비해 1년 전체 생존율이 2.5배 증가하고, 사망 위험이 38% 감소했으며, 18개월 생존 확률은 대조군의 0%에 비해 13.6%였습니다.
Actuate Therapeutics (NASDAQ : ACTU) a annoncé des résultats significatifs de son essai de phase 2 combinant l'elraglusib avec le gemcitabine/nab-paclitaxel (GnP) pour le traitement du cancer du pancréas métastatique. Les patients ayant reçu au moins un cycle ont montré une survie médiane globale améliorée de 12,5 mois contre 8,5 mois dans le groupe contrôle, avec une réduction du risque de décès de 43%.
L'essai a démontré des résultats améliorés avec la combinaison elraglusib/GnP, incluant un taux de contrôle de la maladie de 53,4% contre 44,8% et un taux de réponse globale de 37,9% contre 29,3%. Notamment, les patients avec des métastases hépatiques ont bénéficié d'une augmentation par 2,5 de la survie globale à 1 an et d'une réduction de 38% du risque de décès par rapport au groupe contrôle, avec une probabilité de survie de 13,6% à 18 mois contre 0% dans le groupe contrôle.
Actuate Therapeutics (NASDAQ: ACTU) berichtete über bedeutende Ergebnisse seiner Phase-2-Studie mit Elraglusib in Kombination mit Gemcitabin/nab-Paclitaxel (GnP) zur Behandlung von metastasiertem Bauchspeicheldrüsenkrebs. Patienten, die mindestens einen Zyklus erhielten, zeigten eine verbesserte mediane Gesamtüberlebenszeit von 12,5 Monaten gegenüber 8,5 Monaten in der Kontrollgruppe, mit einer Reduktion des Sterberisikos um 43%.
Die Studie zeigte verbesserte Ergebnisse mit der Elraglusib/GnP-Kombination, einschließlich einer Krankheitskontrollrate von 53,4% gegenüber 44,8% und einer Gesamtansprechrate von 37,9% gegenüber 29,3%. Besonders Patienten mit Lebermetastasen erfuhren eine 2,5-fache Steigerung des 1-Jahres-Gesamtüberlebens und ein um 38% reduziertes Sterberisiko im Vergleich zur Kontrollgruppe, mit einer Überlebenswahrscheinlichkeit von 13,6% nach 18 Monaten gegenüber 0% in der Kontrollgruppe.
- Significant 4-month improvement in median overall survival (12.5 vs 8.5 months)
- 43% reduction in risk of death for patients treated with at least one cycle
- Higher disease control rate (53.4% vs 44.8%) and overall response rate (37.9% vs 29.3%)
- 2.5-fold increase in 1-year overall survival for liver metastasis patients
- 13.6% survival probability at 18 months for liver metastasis patients vs 0% in control group
- None.
Insights
Actuate's elraglusib shows promising survival benefits in pancreatic cancer patients, particularly those with liver metastases.
The Phase 2 trial results for elraglusib represent a potentially significant advancement in metastatic pancreatic adenocarcinoma (mPDAC) treatment. The 4-month improvement in median overall survival (12.5 vs 8.5 months) and 43% reduction in death risk in patients receiving at least one treatment cycle demonstrates meaningful clinical benefit in a cancer with historically poor outcomes.
Most striking is the efficacy in patients with liver metastases, who typically have dismal prognoses. The 2.5-fold increase in 1-year survival and 38% reduction in death risk in this subpopulation is particularly noteworthy. While the control arm showed 0% survival probability at 18 months, the elraglusib arm maintained 13.6% survival - a substantial difference in this aggressive disease setting.
The mechanism targeting glycogen synthase kinase-3 beta (GSK-3β) represents a novel approach. The improved disease control rate (53.4% vs 44.8%) and response rate (37.9% vs 29.3%) suggest elraglusib enhances the effectiveness of standard gemcitabine/nab-paclitaxel therapy.
These results are particularly important given that pancreatic cancer remains one of the deadliest malignancies with limited therapeutic options. The rapid onset of benefit (after just one 4-week treatment cycle) could prove especially valuable for patients who often present with advanced disease and limited treatment windows.
- Near doubling of 1-year overall survival (OS), increased median OS of 4 months (12.5 vs 8.5 months), and
- Patients with liver metastases experienced a 2.5x improvement in 1-year OS with a
CHICAGO and FORT WORTH, Texas, June 24, 2025 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today highlighted results from a pre-specified subgroup analysis of its Phase 2 (Actuate-1801 Part 3B) trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in first-line metastatic pancreatic adenocarcinoma (mPDAC).
Patients treated for at least one complete cycle (4 weeks) of therapy achieved a median overall survival (mOS) of 12.5 months in the elragusib/GnP arm, compared to 8.5 months in the control arm. The analysis showed a
Figure 1: Actuate-1801 Part 3B: Kaplan-Meier Estimate for mOS of Patients Receiving At Least One Complete Cycle of Treatment
In patients with liver metastases, treatment with elraglusib led to a 2.5-fold increase in 1-year OS and a
Additional clinical benefit was observed across other subgroups:
Figure 2: Elraglusib + GnP Data Show OS Benefit Across Key Subgroups
“We are highly encouraged by the significant clinical benefit provided by elraglusib demonstrated in this study,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “Patients who received at least one cycle – or 4 weeks – of elraglusib showed a rapid and meaningful survival benefit, including a near doubling of the 1-year overall survival and
About Metastatic Pancreatic Cancer
Metastatic pancreatic ductal adenocarcinoma (mPDAC) is an advanced stage of pancreatic cancer, the most common type of pancreatic malignancy, originating from the ductal cells of the pancreas. When metastatic, the cancer has spread beyond the pancreas to distant organs, such as the liver, lungs, or peritoneum, and is typically classified as stage IV. mPDAC accounts for approximately
About Actuate Therapeutics, Inc.
Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate’s lead investigational drug, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy through the inhibition of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and DNA Damage Response (DDR). Elraglusib may also mediate anti-tumor immunity through the regulation of multiple immune checkpoints and immune cell function. For additional information, please visit the Company’s website at http://www.actuatetherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements about us, including our and other parties’ clinical trials and development plans, and our industry. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements related to present facts or current conditions or of historical facts, contained in this press release are forward-looking statements. Accordingly, these statements involve estimates, assumptions, substantial risks and uncertainties which could cause actual results to differ materially from those expressed in them, including but not limited to that preliminary and unpublished data may be subject to change and further interpretation following the availability of more data or following a more comprehensive review of the data and should not be relied upon as a final analysis; clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes, results of prior preclinical studies, early clinical trials and sub-group studies are not necessarily predictive of future results and may not correlate with improved responses, and elraglusib may not achieve positive clinical results or favorable preclinical results or receive regulatory approval on a timely basis, if at all; that we may not successfully enroll additional patients or establish or advance plans for further development, including through conversations with the FDA or EMA and the standards such bodies may impose for such development; that elraglusib could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude regulatory approval, cause us to suspend or discontinue clinical trials or result in other negative consequences; our reliance on third parties to conduct our non-clinical studies and our clinical trials; our reliance on third-party licensors and ability to preserve and protect our intellectual property rights; that we face significant competition from other biotechnology and pharmaceutical companies; our ability to fund development activities, including because our financial condition raises substantial doubt as to our ability to continue as a going concern and we require additional capital to finance our operations beyond the second quarter of fiscal year 2025, and a failure to obtain this necessary capital in the near term on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations. In addition, any forward-looking statements are qualified in their entirety by reference to the factors discussed under the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 13, 2025, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 15, 2025, and other filings with the SEC. Because the risk factors referred to above could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Unless legally required, we do not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.
Investor Contact
Mike Moyer
Managing Director
LifeSci Advisors, LLC
mmoyer@lifesciadvisors.com
Media Contact
Ignacio Guerrero-Ros, Ph.D., or David Schull
Russo Partners, LLC
Ignacio.guerrero-ros@russopartnersllc.com
David.schull@russopartnersllc.com
(858) 717-2310 or (646) 942-5604
Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/63b3837b-5be5-416e-a671-237a3f155773
https://www.globenewswire.com/NewsRoom/AttachmentNg/7c9dc33e-cd62-4cc5-b3a0-e8660eefc9a8
FAQ
What were the key results of Actuate Therapeutics (ACTU) Phase 2 elraglusib trial in pancreatic cancer?
How did elraglusib affect liver metastasis patients in ACTU's Phase 2 trial?
What were the disease control and response rates for ACTU's elraglusib in the Phase 2 trial?
What is the mechanism of action for Actuate Therapeutics' elraglusib?
How long did patients need to be treated with elraglusib to show survival benefits?
