Positive Data from Phase II Trial in Soft Tissue Sarcoma Presented at CTOS 2024 Annual Meeting
Immutep announced positive data from EFTISARC-NEO, a Phase II trial evaluating eftilagimod alpha (efti) combined with radiotherapy and KEYTRUDA® in soft tissue sarcoma (STS) patients. The preliminary analysis of 21 patients showed the triple combination achieved a three-fold increase in tumor hyalinization/fibrosis (median 50%) compared to standard radiotherapy's historical 15%. 71.4% of patients achieved pathologic response (≥35% hyalinization/fibrosis) and 9.5% achieved complete pathologic response. The treatment demonstrated safety with no grade ≥3 toxicities related to efti and pembrolizumab. The study aims to enroll 40 patients by Q1 2025.
Immutep ha annunciato risultati positivi da EFTISARC-NEO, uno studio di Fase II che valuta l'efficacia dell'eftilagimod alfa (efti) in combinazione con radioterapia e KEYTRUDA® in pazienti affetti da sarcoma dei tessuti molli (STS). L'analisi preliminare di 21 pazienti ha mostrato che la combinazione tripla ha raggiunto un aumento di tre volte nell'iperemia/fibrosi tumorale (mediana 50%) rispetto al 15% storico della radioterapia standard. Il 71,4% dei pazienti ha ottenuto una risposta patologica (≥35% di iperemia/fibrosi) e il 9,5% ha raggiunto una risposta patologica completa. Il trattamento ha dimostrato sicurezza senza tossicità di grado ≥3 correlate a efti e pembrolizumab. Lo studio prevede di arruolare 40 pazienti entro il primo trimestre del 2025.
Immutep anunció datos positivos del EFTISARC-NEO, un ensayo de Fase II que evalúa eftilagimod alfa (efti) combinado con radioterapia y KEYTRUDA® en pacientes con sarcoma de tejidos blandos (STS). El análisis preliminar de 21 pacientes mostró que la combinación triple logró un aumento de tres veces en la hialinización/fibrosis tumoral (mediana 50%) en comparación con el 15% histórico de la radioterapia estándar. El 71.4% de los pacientes logró una respuesta patológica (≥35% hialinización/fibrosis) y el 9.5% logró una respuesta patológica completa. El tratamiento demostró seguridad sin toxicidades de grado ≥3 relacionadas con efti y pembrolizumab. El estudio tiene como objetivo inscribir a 40 pacientes para el primer trimestre de 2025.
Immutep는 연부조직육종(STS) 환자에서 방사선 요법 및 KEYTRUDA®와 결합된 eftilagimod alpha (efti)의 효능을 평가하는 2상 시험 EFTISARC-NEO의 긍정적인 데이터를 발표했습니다. 21명의 환자에 대한 초기 분석 결과, 삼중 조합이 종양의 유리화/섬유증에서 세 배 증가 (중앙값 50%)를 달성했으며, 이는 표준 방사선 요법의 역사적 평균 15%에 비해 상당한 증가입니다. 71.4%의 환자가 병리학적 반응을 달성했습니다 (≥35% 유리화/섬유증) 및 9.5%는 완전 병리학적 반응을 보였습니다. 치료는 efti와 pembrolizumab에 관련된 3도 이상의 독성을 보이지 않아 안전성을 입증했습니다. 이 연구는 2025년 1분기까지 40명의 환자를 등록할 계획입니다.
Immutep a annoncé des données positives concernant EFTISARC-NEO, un essai de phase II évaluant l'eftilagimod alpha (efti) en combinaison avec la radiothérapie et KEYTRUDA® chez des patients atteints de sarcome des tissus mous (STS). L'analyse préliminaire de 21 patients a montré que la combinaison triple a obtenu une augmentation de trois fois de l'hyalinisation/fibrose tumorale (médiane 50%) par rapport à 15% historiques de la radiothérapie standard. 71,4% des patients ont obtenu une réponse pathologique (≥35% d'hyalinisation/fibrose) et 9,5% ont obtenu une réponse pathologique complète. Le traitement a montré une sécurité sans toxicités de grade ≥3 liées à efti et pembrolizumab. L'étude vise à recruter 40 patients d'ici le premier trimestre 2025.
Immutep hat positive Daten aus EFTISARC-NEO bekannt gegeben, einer Phase-II-Studie, die die Wirksamkeit von eftilagimod alpha (efti) in Kombination mit Radiotherapie und KEYTRUDA® bei Patienten mit Weichgewebesarkomen (STS) bewertet. Die vorläufige Analyse von 21 Patienten zeigte, dass die dreifache Kombination eine dreißigfache Steigerung der Tumorhyalinisation/Fibrose (Median 50%) im Vergleich zu den historischen 15% der Standardradiotherapie erreichte. 71,4% der Patienten erreichten eine pathologische Reaktion (≥35% Hyalinisation/Fibrose) und 9,5% erreichten eine vollständige pathologische Reaktion. Die Behandlung zeigte Sicherheit ohne Grad ≥3 toxische Nebenwirkungen im Zusammenhang mit efti und Pembrolizumab. Die Studie zielt darauf ab, bis zum 1. Quartal 2025 40 Patienten zu rekrutieren.
- Triple combination achieved 50% median tumor hyalinization vs 15% historical baseline
- 71.4% of patients achieved pathologic response
- 9.5% of patients achieved complete pathologic response
- No grade ≥3 toxicities related to treatment
- Efficacy observed across different STS subtypes
- Study still ongoing with preliminary results from only 21 of planned 40 patients
Insights
The Phase II EFTISARC-NEO trial results demonstrate significant clinical progress for Immutep's efti in treating soft tissue sarcoma (STS). The key findings show a three-fold increase in tumor hyalinization (
The
This positive clinical data strengthens Immutep's market position in oncology immunotherapy. The trial's success in STS, a difficult-to-treat indication, could expand efti's potential market opportunities beyond its current development programs. The Polish government grant funding support reduces the company's R&D burden while advancing clinical development.
For investors, these results represent a significant de-risking event for efti's development program. The triple combination therapy's efficacy data could support future partnership discussions or licensing opportunities. With a market cap of
Media Release
- Efti in combination with pembrolizumab and radiotherapy demonstrates significant efficacy in the neoadjuvant setting in patients with soft tissue sarcoma
- Over three-fold increase in tumour hyalinization, the primary endpoint of the study and an important predictor of overall survival, as compared to historical results from radiotherapy alone
SYDNEY, AUSTRALIA, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the presentation of new data from EFTISARC-NEO, a Phase II investigator-initiated trial of eftilagimod alpha (efti) in combination with radiotherapy plus KEYTRUDA® (pembrolizumab) for patients with soft tissue sarcoma (STS), at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting. Based on preliminary analysis among 21 patients available for primary endpoint assessment, the triple combination therapy demonstrates significant efficacy in the neoadjuvant setting for resectable STS.
Katarzyna Kozak, M.D., Ph.D., and Paweł Sobczuk, M.D., Ph.D., medical oncologists at the Department of Soft Tissue/Bone Sarcoma and Melanoma at MSCNRIO (Warsaw) and the trial’s principal investigators, stated: “Our belief in efti’s unique mechanism of action to complement radiotherapy and pembrolizumab in order drive better outcomes for patients with this rare aggressive disease was the foundation of the EFTISARC-NEO trial. These very encouraging results we are presenting today build our confidence in the synergistic effects of this new therapeutic approach and its potential to treat these patients in dire need of more effective therapies. In particular, the high level of hyalinization/fibrosis achieved with this novel combination therapy, three-times above historical results from standard radiotherapy, demonstrates remarkable efficacy in patients with resectable soft tissue sarcomas.”
In the neoadjuvant setting for patients with resectable STS, the combination achieved a greater than three-fold increase in tumour hyalinization/fibrosis (median
The EFTISARC-NEO trial, with a data cut-off of 20 October 2024, also showed
Dr. Frédéric Triebel, CSO of Immutep, said: “We are pleased with the strength of these preliminary results in this difficult-to-treat cancer. To see
The ongoing open-label EFTISARC-NEO Phase II study, conducted by the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, is expected to reach the planned enrolment of 40 patients in Q1 CY2025. The trial is primarily funded with an approved grant from the Polish government awarded by the Polish Medical Research Agency program. For more information, visit clinicaltrials.gov (NCT06128863).
The CTOS poster is available on the Posters & Publications section of Immutep’s website.
About Immutep
Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique 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.
Australian Investors/Media:
Catherine Strong, Sodali & Co
+61 (0)406 759 268; catherine.strong@sodali.com
U.S. Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
- Schaefer IM, Hornick JL, Barysauskas CM, Raut CP, Patel SA, Royce TJ, Fletcher CDM, Baldini EH. Histologic Appearance After Preoperative Radiation Therapy for Soft Tissue Sarcoma: Assessment of the European Organization for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group Response Score. Int J Radiat Oncol Biol Phys. 2017 Jun 1;98(2):375-383. doi: 10.1016/j.ijrobp.2017.02.087. Epub 2017 Feb 24. PMID: 28463157.
- Rao SR, Lazarides AL, Leckey BL, Lane WO, Visgauss JD, Somarelli JA, Kirsch DG, Larrier NA, Brigman BE, Blazer DG, Cardona DM, Eward WC. Extent of tumor fibrosis/hyalinization and infarction following neoadjuvant radiation therapy is associated with improved survival in patients with soft-tissue sarcoma. Cancer Med. 2022 Jan;11(1):194-206. doi: 10.1002/cam4.4428. Epub 2021 Nov 27. PMID: 34837341; PMCID: PMC8704179.
FAQ
What are the key results of Immutep's (IMMP) Phase II EFTISARC-NEO trial?
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