Immutep Announces Data from EFTISARC-NEO Phase II Evaluating Neoadjuvant Efti in Soft Tissue Sarcoma Accepted for Oral Presentation at CTOS 2025
Immutep (NASDAQ: IMMP) announced that data from its EFTISARC-NEO Phase II trial has been accepted for oral presentation at the CTOS 2025 Annual Meeting. The groundbreaking study evaluates eftilagimod alpha (efti) in combination with radiotherapy and KEYTRUDA® for soft tissue sarcoma (STS) patients in a neoadjuvant setting.
The presentation will be delivered by Dr. Pawel Sobczuk on November 13, 2025, focusing on the primary endpoint and translational correlates from the trial. This research addresses a significant unmet medical need, as STS affects approximately 13,520 new patients in the US annually, with an estimated 5,420 deaths in 2025.
The study is being conducted at the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland, with primary funding from the Polish government.
Immutep (NASDAQ: IMMP) ha annunciato che i dati del suo trial di Fase II EFTISARC-NEO sono stati accettati per una presentazione orale al CTOS 2025 Annual Meeting. Lo studio innovativo valuta eftilagimod alfa (efti) in combinazione con radioterapia e KEYTRUDA® nei pazienti con sarcoma dei tessuti molli (STS) in setting neoadiuvante.
La presentazione sarà tenuta dal Dr. Pawel Sobczuk il 13 novembre 2025 e si concentrerà sull'endpoint primario e sui correlati traslazionali dello studio. Questa ricerca risponde a un importante bisogno medico non soddisfatto: negli USA lo STS colpisce circa 13.520 nuovi pazienti ogni anno, con una stima di 5.420 decessi nel 2025.
Lo studio è condotto presso il Maria Skłodowska-Curie National Research Institute of Oncology di Varsavia, Polonia, con finanziamento principale da parte del governo polacco.
Immutep (NASDAQ: IMMP) anunció que los datos de su ensayo de Fase II EFTISARC-NEO han sido aceptados para una presentación oral en la Reunión Anual CTOS 2025. Este estudio innovador evalúa eftilagimod alfa (efti) en combinación con radioterapia y KEYTRUDA® en pacientes con sarcoma de tejidos blandos (STS) en un contexto neoadyuvante.
La presentación la realizará el Dr. Pawel Sobczuk el 13 de noviembre de 2025 y se centrará en el criterio de valoración primario y en los correlatos traslacionales del ensayo. Esta investigación aborda una necesidad médica significativa, ya que en EE. UU. el STS afecta aproximadamente a 13.520 nuevos pacientes al año, con una estimación de 5.420 muertes en 2025.
El estudio se está llevando a cabo en el Maria Skłodowska-Curie National Research Institute of Oncology en Varsovia, Polonia, con financiación principal del gobierno polaco.
Immutep (NASDAQ: IMMP)는 EFTISARC-NEO 2상 임상시험의 데이터가 CTOS 2025 연례회의에서 구두 발표로 채택되었다고 발표했습니다. 이 획기적인 연구는 연성 조직 육종(STS) 환자의 네오아주번트 환경에서 방사선치료 및 KEYTRUDA®와 병용한 eftilagimod alpha(efti)를 평가합니다.
발표는 Dr. Pawel Sobczuk가 2025년 11월 13일에 진행하며, 연구의 주요 평가변수와 전환적 상관분석 결과를 중심으로 다룰 예정입니다. 이 연구는 중요한 미충족 의료 수요를 해결하는데 기여하는데, 미국에서는 매년 약 13,520명의 신규 환자가 STS로 진단되며 2025년에는 약 5,420명의 사망이 예상됩니다.
해당 연구는 폴란드 바르샤바에 위치한 Maria Skłodowska-Curie 국립 암 연구소에서 수행되며, 주요 자금은 폴란드 정부가 제공합니다.
Immutep (NASDAQ: IMMP) a annoncé que les données de son essai de phase II EFTISARC-NEO ont été retenues pour une présentation orale lors de la réunion annuelle CTOS 2025. Cette étude innovante évalue l'eftilagimod alpha (efti) en combinaison avec la radiothérapie et KEYTRUDA® chez des patients atteints de sarcome des tissus mous (STS) en contexte néoadjuvant.
La présentation sera assurée par le Dr. Pawel Sobczuk le 13 novembre 2025 et portera sur le critère d'évaluation principal ainsi que sur les corrélats translationnels de l'essai. Cette recherche répond à un besoin médical important non satisfait : aux États-Unis, environ 13 520 nouveaux patients sont atteints de STS chaque année, avec une estimation de 5 420 décès en 2025.
L'étude est menée au Maria Skłodowska-Curie National Research Institute of Oncology à Varsovie, en Pologne, avec un financement principal du gouvernement polonais.
Immutep (NASDAQ: IMMP) gab bekannt, dass Daten aus der EFTISARC-NEO Phase-II-Studie zur mündlichen Präsentation auf dem CTOS 2025 Annual Meeting angenommen wurden. Die wegweisende Studie untersucht eftilagimod alpha (efti) in Kombination mit Strahlentherapie und KEYTRUDA® bei Patienten mit Weichteilsarkom (STS) im neoadjuvanten Setting.
Die Präsentation wird am 13. November 2025 von Dr. Pawel Sobczuk gehalten und fokussiert sich auf den primären Endpunkt sowie auf translationsbezogene Korrelate der Studie. Die Forschung adressiert einen bedeutenden ungedeckten medizinischen Bedarf: In den USA erkranken jährlich etwa 13.520 neue Patienten an STS, mit geschätzten 5.420 Todesfällen im Jahr 2025.
Die Studie wird am Maria Skłodowska-Curie National Research Institute of Oncology in Warschau, Polen, durchgeführt und primär vom polnischen Staat finanziert.
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Insights
Immutep's Phase II EFTISARC-NEO trial data acceptance for oral presentation suggests promising results for efti in sarcoma treatment.
The acceptance of Immutep's EFTISARC-NEO Phase II trial data for oral presentation at the CTOS 2025 Annual Meeting represents a potentially significant milestone for the company's cancer immunotherapy program. Oral presentations at major medical conferences are typically reserved for studies with meaningful results, suggesting the data may be promising, though no specific efficacy outcomes are disclosed in this announcement.
This trial is exploring eftilagimod alpha (efti) in a novel triple combination with radiotherapy and Merck's KEYTRUDA® (pembrolizumab) as a neoadjuvant treatment for soft tissue sarcoma (STS). The neoadjuvant setting—treatment before surgery—is particularly interesting as it could potentially improve surgical outcomes and reduce recurrence rates for STS patients.
Soft tissue sarcoma represents a significant unmet medical need with approximately 13,520 new cases and 5,420 deaths expected in the US in 2025. The mortality-to-incidence ratio exceeds
Immutep's efti is a soluble LAG-3 protein that activates antigen-presenting cells to stimulate CD8+ T cells, potentially enhancing immune responses against tumors. The combination with pembrolizumab (an anti-PD-1 therapy) plus radiotherapy represents a multi-modal approach that could overcome immune resistance mechanisms in the tumor microenvironment.
Investors should note that while this announcement confirms data presentation, it doesn't provide efficacy results. The full data disclosure on November 13th will be crucial for assessing efti's potential in this indication and its broader implications for Immutep's clinical development strategy.
- Data to be presented in the Immunotherapy & Cell Therapy in Sarcoma: Emerging Frontiers session at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting
SYDNEY, AUSTRALIA, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces an abstract for the EFTISARC-NEO Phase II investigator-initiated trial has been accepted for oral presentation at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting taking place 12-15 November 2025, in Boca Raton, Florida.
EFTISARC-NEO is the first study to evaluate eftilagimod alpha (efti) in a neoadjuvant setting (prior to surgery) administered in combination with radiotherapy plus KEYTRUDA® (pembrolizumab) for patients with soft tissue sarcoma (STS).
| Presentation Details | |
| Title: | Primary endpoint and translational correlates from EFTISARC-NEO: phase II trial of neoadjuvant eftilagimod alpha (efti), pembrolizumab, and radiotherapy in patients with resectable soft tissue sarcoma |
| Session: | Immunotherapy & Cell Therapy in Sarcoma: Emerging Frontiers |
| Presenter: | Pawel Sobczuk, M.D., Ph.D., Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of Oncology |
| Date: | Thursday, 13 November 2025, 1:30 PM – 3:00 PM ET |
| Format: | Oral Presentation |
STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.1
EFTISARC-NEO is is being conducted by the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland. The study is primarily funded with an approved grant from the Polish government awarded by the Polish Medical Research Agency program. For more information on the trial visit clinicaltrials.gov (NCT06128863).
The presentation slides will be available on the Posters & Publications section of Immutep’s website after the presentation at CTOS 2025.
About Immutep
Immutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3’s ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com.
1. American Cancer Society statistics: https://www.cancer.org/cancer/types/soft-tissue-sarcoma/about/key-statistics.html
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Australian Investors/Media:
Eleanor Pearson, Sodali & Co.
+61 2 9066 4071; eleanor.pearson@sodali.com
U.S. Investors/Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
FAQ
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