Patient Enrolment Completed for EFTISARC-NEO Phase II Trial
Immutep (IMMP) has completed patient enrollment for its Phase II EFTISARC-NEO trial, reaching the target of 40 patients. The trial evaluates eftilagimod alpha (efti) in combination with radiotherapy plus KEYTRUDA® for patients with resectable soft tissue sarcoma (STS).
Preliminary data presented at the CTOS Annual Meeting in November 2024 showed promising results. Among 21 patients assessed, the triple combination achieved a median tumor hyalinization/fibrosis of 50%, representing a three-fold increase compared to the historical median of 15% from radiotherapy alone. This early surrogate endpoint is associated with improved survival for STS patients.
The treatment has demonstrated a favorable safety profile with no grade ≥3 toxicities related to efti and pembrolizumab. Further data updates are expected in 2025.
Immutep (IMMP) ha completato l'arruolamento dei pazienti per il suo trial di Fase II EFTISARC-NEO, raggiungendo l'obiettivo di 40 pazienti. Lo studio valuta eftilagimod alpha (efti) in combinazione con radioterapia e KEYTRUDA® per pazienti con sarcoma dei tessuti molli (STS) resecabile.
I dati preliminari presentati durante il Meeting Annuale CTOS a novembre 2024 hanno mostrato risultati promettenti. Tra 21 pazienti valutati, la combinazione tripla ha raggiunto un median tumor hyalinization/fibrosis del 50%, rappresentando un aumento triplo rispetto al mediano storico del 15% della sola radioterapia. Questo primo endpoint surrogato è associato a una migliore sopravvivenza per i pazienti con STS.
Il trattamento ha dimostrato un profilo di sicurezza favorevole, senza tossicità di grado ≥3 correlate a efti e pembrolizumab. Ulteriori aggiornamenti sui dati sono attesi nel 2025.
Immutep (IMMP) ha completado el reclutamiento de pacientes para su ensayo de Fase II EFTISARC-NEO, alcanzando el objetivo de 40 pacientes. El ensayo evalúa eftilagimod alpha (efti) en combinación con radioterapia y KEYTRUDA® para pacientes con sarcoma de tejidos blandos (STS) resecable.
Los datos preliminares presentados en la Reunión Anual CTOS en noviembre de 2024 mostraron resultados prometedores. Entre 21 pacientes evaluados, la combinación triple logró un median tumor hyalinization/fibrosis del 50%, lo que representa un aumento triple en comparación con la mediana histórica del 15% de la radioterapia sola. Este primer punto final sustituto está asociado con una mejor supervivencia para los pacientes con STS.
El tratamiento ha demostrado un perfil de seguridad favorable, sin toxicidades de grado ≥3 relacionadas con efti y pembrolizumab. Se esperan más actualizaciones de datos en 2025.
Immutep (IMMP)는 40명의 환자 모집 목표를 달성하며 Phase II EFTISARC-NEO 시험에 참가자를 모집 완료하였습니다. 이 시험은 수술 가능한 연부조직 육종(STS) 환자를 대상으로 eftilagimod alpha (efti)와 방사선 요법, KEYTRUDA®의 병용 치료를 평가합니다.
2024년 11월 CTOS 연례 회의에서 발표된 초기 데이터는 유망한 결과를 보여주었습니다. 평가받은 21명의 환자 중 세 가지 조합이 50%의 종양 하이알리니제이션/섬유화 중간값을 달성하여, 방사선 요법만을 이용한 과거의 15% 중앙값에 비해 세 배 증가한 결과를 나타냈습니다. 이 초기 대리 지표는 STS 환자의 생존 개선과 관련이 있습니다.
이 치료는 efti와 pembrolizumab과 관련된 3등급 이상의 독성이 없는 안정적인 안전성 프로필을 보였습니다. 추가 데이터 업데이트는 2025년에 있을 예정입니다.
Immutep (IMMP) a terminé le recrutement des patients pour son essai de Phase II EFTISARC-NEO, atteignant l'objectif de 40 patients. L'essai évalue eftilagimod alpha (efti) en combinaison avec la radiothérapie et KEYTRUDA® pour les patients atteints de sarcome des tissus mous (STS) resecables.
Les données préliminaires présentées lors de la réunion annuelle de la CTOS en novembre 2024 ont montré des résultats prometteurs. Parmi les 21 patients évalués, la combinaison triple a atteint une médiane d'hyalinisation/fibrose tumorale de 50%, représentant une augmentation triple par rapport à la médiane historique de 15% de la radiothérapie seule. Ce premier critère d'évaluation substitut est associé à une amélioration de la survie des patients atteints de STS.
Le traitement a démontré un profil de sécurité favorable, sans toxicités de grade ≥3 liées à efti et pembrolizumab. D'autres mises à jour de données sont attendues en 2025.
Immutep (IMMP) hat die Patientenrekrutierung für seine Phase-II-Studie EFTISARC-NEO abgeschlossen und das Ziel von 40 Patienten erreicht. Die Studie bewertet eftilagimod alpha (efti) in Kombination mit Strahlentherapie und KEYTRUDA® für Patienten mit resezierbarem Weichgewebesarkom (STS).
Vorläufige Daten, die auf dem CTOS-Jahrestreffen im November 2024 präsentiert wurden, zeigten vielversprechende Ergebnisse. Unter 21 bewerteten Patienten erreichte die dreifache Kombination eine median Tumor-Hyalinization/Fibrose von 50%, was einem dreifachen Anstieg im Vergleich zum historischen Median von 15% der alleinigen Strahlentherapie entspricht. Dieser frühe surrogate Endpunkt ist mit einer verbesserten Überlebensrate für STS-Patienten verbunden.
Die Behandlung hat ein günstiges Sicherheitsprofil gezeigt, ohne Grad ≥3-Toxizitäten im Zusammenhang mit efti und Pembrolizumab. Weitere Datenaktualisierungen werden für 2025 erwartet.
- Trial reached full enrollment target of 40 patients
- Triple combination showed 50% median tumor hyalinization vs 15% historical data
- No significant safety concerns observed (no grade ≥3 toxicities)
- Complete trial results not available until 2025
- Data based on interim analysis of 21 patients out of 40
Insights
The completion of patient enrollment in the EFTISARC-NEO Phase II trial marks a important advancement in Immutep's clinical program. The study combines three treatment modalities: eftilagimod alpha (Immutep's lead drug), radiotherapy and KEYTRUDA® - Merck's blockbuster immunotherapy - for patients with soft tissue sarcoma (STS).
The preliminary data is particularly encouraging, showing a median 50% tumor hyalinization/fibrosis rate compared to just 15% with radiotherapy alone. In simple terms, this means the combination therapy is more effectively turning active cancer tissue into harmless scar tissue - a strong indicator of treatment success. This three-fold improvement suggests the triple combination could potentially transform the standard of care for STS patients.
The clean safety profile, with no serious adverse events linked to efti and KEYTRUDA, is equally significant. This suggests the potential for broad clinical adoption if the treatment proves successful in later stages. The collaboration with KEYTRUDA is strategically valuable, as positive results could position efti as a complementary therapy to this
Looking ahead, investors should monitor several key aspects: 1) Complete efficacy data expected in 2025, particularly survival outcomes 2) Potential expansion into other sarcoma subtypes 3) Regulatory interactions regarding the path to approval, given the significant unmet need in STS treatment.
- Phase II trial evaluating efti in combination with radiotherapy plus KEYTRUDA® (pembrolizumab) in patients with soft tissue sarcoma reaches enrolment target of 40 patients
- Data updates from EFTISARC-NEO expected in 2025
SYDNEY, AUSTRALIA, Jan. 22, 2025 (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 that patient enrolment has been completed in the investigator-initiated EFTISARC-NEO trial. EFTISARC-NEO is evaluating eftilagimod alpha (efti) in combination with radiotherapy plus KEYTRUDA® (pembrolizumab) in the neoadjuvant setting for patients with resectable soft tissue sarcoma (STS).
The Phase II trial conducted by the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre for STS in Poland, has reached its enrolment target of 40 patients.
As previously announced, positive data from EFTISARC-NEO was presented at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2024. Among 21 patients available for primary endpoint assessment, the triple combination achieved a greater than three-fold increase in tumour hyalinization/fibrosis (median
Additionally, the treatment has been safe with no grade ≥3 toxicities related to efti and pembrolizumab.
Data updates from EFTISARC-NEO are expected in 2025. For more information on the trial, please visit clinicaltrials.gov (NCT06128863).
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.
1. Schaefer IM et al. 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.
2. Rao SR et al. 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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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
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