Actuate Therapeutics Announces Positive Interim Phase 2 Data of Elraglusib in First Line Treatment of Metastatic Pancreatic Cancer
Actuate Therapeutics (NASDAQ: ACTU) announced positive interim Phase 2 data for elraglusib combined with gemcitabine/nab-paclitaxel (GnP) in first-line treatment of metastatic pancreatic cancer. The trial met statistical significance on primary endpoints, showing a 43.6% one-year survival rate versus 22.5% in the control group (p=0.002) and a 37% reduction in death risk. Median overall survival increased to 9.3 months compared to 7.2 months in the control arm.
The study demonstrated favorable safety profile with treatment-emergent adverse events similar to the control group. The objective response rate was 27.7% and disease control rate 42.6% in the combination arm versus 20.5% and 33.3% in the control arm. The trial enrolled 286 patients and continues with topline data expected in 1H 2025.
Actuate Therapeutics (NASDAQ: ACTU) ha annunciato dati interim positivi della fase 2 per l'elraglusib combinato con gemcitabina/nab-paclitaxel (GnP) nel trattamento di prima linea del cancro pancreatico metastatico. Lo studio ha raggiunto la significatività statistica sui punti finali primari, mostrando un tasso di sopravvivenza a un anno del 43,6% rispetto al 22,5% nel gruppo di controllo (p=0,002) e una riduzione del 37% del rischio di morte. La sopravvivenza mediana complessiva è aumentata a 9,3 mesi rispetto ai 7,2 mesi nel braccio di controllo.
Lo studio ha dimostrato un profilo di sicurezza favorevole con eventi avversi emergenti da trattamento simili a quelli del gruppo di controllo. Il tasso di risposta obiettiva era del 27,7% e il tasso di controllo della malattia del 42,6% nel braccio combinato rispetto al 20,5% e 33,3% nel braccio di controllo. Lo studio ha arruolato 286 pazienti e continua con dati preliminari attesi nel primo semestre del 2025.
Actuate Therapeutics (NASDAQ: ACTU) anunció datos interinos positivos de la fase 2 para elraglusib combinado con gemcitabina/nab-paclitaxel (GnP) en el tratamiento de primera línea para el cáncer de páncreas metastásico. El ensayo alcanzó significación estadística en los puntos finales primarios, mostrando una tasa de supervivencia a un año del 43,6% frente al 22,5% en el grupo de control (p=0,002) y una reducción del 37% en el riesgo de muerte. La supervivencia global mediana aumentó a 9,3 meses en comparación con 7,2 meses en el grupo de control.
El estudio demostró un perfil de seguridad favorable con eventos adversos emergentes del tratamiento similares al grupo de control. La tasa de respuesta objetivo fue del 27,7% y la tasa de control de la enfermedad del 42,6% en el brazo combinado frente al 20,5% y 33,3% en el brazo de control. El ensayo inscribió a 286 pacientes y continúa, con datos preliminares esperados en la primera mitad de 2025.
Actuate Therapeutics (NASDAQ: ACTU)는 전이성 췌장암의 1차 치료에서 엘라글루시브와 젬시타빈/납-탁세롤(GnP)을 병용한 긍정적인 2상 임상시험 중간 데이터를 발표했습니다. 이 시험은 주요 평가 지점에서 통계적 유의성을 달성했으며, 1년 생존율이 43.6%로, 대조군의 22.5% (p=0.002)에 비해 우수한 결과를 보였고, 사망 위험을 37% 감소시켰습니다. 중앙 전체 생존 기간은 대조군의 7.2개월에 비해 9.3개월로 증가했습니다.
이 연구는 대조군과 유사한 치료에서 발생한 불리한 사건을 포함한 유리한 안전성 프로필을 보여주었습니다. 병용 요법의 객관적 반응률은 27.7%, 질병 조절률은 42.6%였으며, 대조군은 각각 20.5%와 33.3%였습니다. 이 임상시험에는 286명이 등록되었으며, 2025년 상반기에 주요 데이터가 예상됩니다.
Actuate Therapeutics (NASDAQ: ACTU) a annoncé des données intermédiaires positives de la phase 2 pour l'elraglusib combiné avec gemcitabine/nab-paclitaxel (GnP) dans le traitement en première ligne du cancer du pancréas métastatique. L'essai a atteint une signification statistique sur les critères principaux, montrant un taux de survie à un an de 43,6% contre 22,5% dans le groupe de contrôle (p=0,002) et une réduction de 37% du risque de décès. La survie médiane globale a augmenté à 9,3 mois par rapport à 7,2 mois dans le bras de contrôle.
L'étude a démontré un profil de sécurité favorable avec des événements indésirables liés au traitement similaires à ceux du groupe de contrôle. Le taux de réponse objectif était de 27,7% et le taux de contrôle de la maladie de 42,6% dans le bras combiné contre 20,5% et 33,3% dans le bras de contrôle. L'essai a recruté 286 patients et se poursuit, avec des données préliminaires attendues au premier semestre 2025.
Actuate Therapeutics (NASDAQ: ACTU) hat positive Zwischenresultate der Phase 2 für Elraglusib in Kombination mit Gemcitabin/Nab-Paclitaxel (GnP) zur erstlinigen Behandlung von metastasiertem Pankreaskrebs bekannt gegeben. Die Studie erreichte statistische Signifikanz bei den primären Endpunkten und zeigte eine Eins-Jahres-Überlebensrate von 43,6% im Vergleich zu 22,5% in der Kontrollgruppe (p=0,002) und eine 37%ige Risiko-reduktion für den Tod. Das mediane Gesamtüberleben erhöhte sich auf 9,3 Monate im Vergleich zu 7,2 Monaten in der Kontrollgruppe.
Die Studie zeigte ein günstiges Sicherheitsprofil mit behandlungsbedingten unerwünschten Ereignissen, die dem der Kontrollgruppe ähnlich waren. Die objektive Ansprechrate betrug 27,7% und die Krankheitskontrollrate 42,6% in der Kombinationstherapie im Vergleich zu 20,5% und 33,3% in der Kontrollgruppe. In der Studie wurden 286 Patienten eingeschlossen, und es werden weiterhin Daten mit den Ergebnissen im ersten Halbjahr 2025 erwartet.
- Statistically significant 43.6% one-year survival rate vs 22.5% in control group
- 37% reduction in risk of death with 9.3 months median survival vs 7.2 months
- Higher objective response rate (27.7% vs 20.5%) and disease control rate (42.6% vs 33.3%)
- Favorable safety profile with adverse events similar to control group
- Two patients with inoperable metastatic lesions achieved surgical eligibility
- None.
Insights
The interim Phase 2 data for elraglusib shows remarkable efficacy in metastatic pancreatic cancer treatment. The doubling of 1-year survival rate (43.6% vs 22.5%, p=0.002) and 37% reduction in death risk are statistically significant improvements. The median overall survival increased by 2.1 months (9.3 vs 7.2 months), which is clinically meaningful for this aggressive cancer type. The drug's favorable safety profile, combined with improved objective response rates and disease control rates, suggests strong commercial potential. The complete responses and 100% reduction in target lesions in some patients are particularly noteworthy, as such outcomes are rare in pancreatic cancer.
These positive Phase 2 results significantly enhance Actuate's market position and potential valuation. With pancreatic cancer's poor survival rates and treatment options, elraglusib's demonstrated efficacy could translate into substantial market opportunity. The planned FDA engagement in 1H 2025 and potential Phase 3 trial represent key catalysts for
- Statistical Significance Met on Primary Endpoints of 1 Year Survival Rate and Median Overall Survival
- Doubling of 1 Year Survival Rate and
37% Reduction in Risk of Death - Two Month (
29% ) Increase in Median Overall Survival - Multiple Patients with Complete Responses (CRs) and/or Partial Response (PR) with
100% Reduction in Target Lesions - Elraglusib in Combination with GnP Demonstrated a Favorable Risk-Benefit Profile
- Trial Continues with Topline Data Anticipated in 1H 2025
CHICAGO and FORT WORTH, Texas, Dec. 17, 2024 (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 announced new positive data from its ongoing and fully enrolled randomized Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in first line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) (Actuate-1801 Part 3B).
A pre-specified analysis was triggered by reaching >
“These interim results are highly encouraging and underscore the transformative potential of elraglusib in the treatment of metastatic pancreatic cancer,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “The improvement in median and overall long-term survival, disease control rate and overall response rate compared to GnP alone, combined with elraglusib’s favorable risk-benefit profile, offers the possibility of improved outcomes for patients with limited treatment alternatives. We are excited to continue evaluating the potential of elraglusib, a novel immune-oncology GSK-3 targeted approach for mPDAC, and look forward to engaging with the FDA in 1H 2025 to share topline data and discuss next steps, including a proposed phase 3 registration trial.”
Inhibition of GSK-3β may inhibit tumor growth and improve survival through several complimentary mechanisms that include enhancement of chemotherapy activity, activation of innate anti-tumor immunity and regulation of gene expression, leading to alterations in tumor metabolism and Epithelial-to-Mesenchymal Transition (EMT).
Study highlights include:
- The interim data met the trial primary endpoint with a 1-year survival rate of
43.6% in the elraglusib-GnP combination arm versus22.5% in the GnP control arm (p=0.002);- Eighteen and twenty-four month survival rates also demonstrated benefit of
20.9% vs0% and16.7% vs0% in the elraglusib-GnP combination vs GnP arms, respectively.
- Eighteen and twenty-four month survival rates also demonstrated benefit of
- As of the November 15, 2024 cutoff,
38% of subjects were still alive in the elraglusib-GnP combination arm vs19% in the GnP control arm. - A statistically significant
37% reduction in risk of death and increased median overall survival were observed in the elraglusib-GnP combination arm (mOS 9.3 months) vs the GnP control arm (mOS 7.2 months), (HR=0.63 p=0.016). - The trial also met its primary safety endpoint. Treatment-emergent adverse events (TEAEs) and Serious Adverse Events (SAEs) in the elraglusib-GnP combination arm were similar to those observed in the GnP arm, indicating a favorable risk-benefit profile for the elraglusib-GnP combination.
- At the interim cutoff of November 15, 2024, the ORR was
27.7% , DCR was 42.6 %, and PFS was 5.6 months in the elraglusib-GnP combination arm versus20.5% ,33.3% and 4.9 months in the GnP arm, respectively. - To date, there have been 2 patients in the elraglusib/GnP combination arm with previously inoperable metastatic lesions with noted reductions in target lesions and referred for successful resection, 1 of which resulted in
100% reduction in total tumor burden after surgery. In addition, there have been 1 Complete Response and 1 Partial Response with100% reduction in target lesions in the elraglusib GnP combination arm versus 0 in the control arm to date.
“Pancreatic cancer is one of the most aggressive and lethal cancers with less than
The ongoing Actuate-1801 Part 3B study (NCT03678883) is a randomized, controlled Phase 2 trial of elraglusib with GnP versus GnP alone in first line mPDAC. The trial enrolled 286 mPDAC patients with no prior systemic treatment for metastatic disease, who were randomized 2:1 to the elraglusib treatment arm (elraglusib + GnP) or the control arm (GnP alone). Elraglusib is administered at a dose of 9.3 mg/kg by IV infusion on Day 1 of each week of a 28-day cycle. The primary endpoint is 1-year survival rate, with mOS the primary parameter for summarization of survival data at the end of the study. Secondary endpoints are DCR, ORR, PFS and AE.
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 product, 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 including several DNA Damage Response (DDR) pathways. Elraglusib is designed to act as a mediator of anti-tumor immunity through the inhibition of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and regulates 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 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 clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes, results of prior preclinical studies and early clinical trials are not necessarily predictive of future results, and elraglusib may not achieve favorable results or expected impacts on tumor growth in clinical trials or preclinical studies 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; 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; preliminary and unpublished data may be subject to change 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; 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; and our ability to fund development activities. 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 filed with the SEC on November 13, 2024 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
FAQ
What are the key Phase 2 results for Actuate's (ACTU) elraglusib in pancreatic cancer?
When will Actuate Therapeutics (ACTU) release topline data for the elraglusib Phase 2 trial?
What is the safety profile of elraglusib in combination with GnP?
How many patients were enrolled in Actuate's (ACTU) Phase 2 trial for elraglusib?
What are the objective response rates for elraglusib in the Phase 2 trial?
