Media Release Novel triple combination of efti with radiotherapy and anti-PD-1 therapy is well tolerated and has led to encouraging initial efficacy data in EFTISARC-NEO Phase II trialFour of six patients treated have very good, near-complete pathologic responses (primary endpoint of study) that are rarely observed with standard therapiesSoft tissue sarcoma is a hard-to-treat orphan disease with poor prognosis & high unmet medical needAdditional data from EFTISARC-NEO planned for a medical conference in H2 CY2024 SYDNEY, AUSTRALIA, May 02, 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 initial encouraging data from EFTISARC-NEO, a Phase II investigator-initiated trial of eftilagimod alpha (efti) in combination with radiotherapy, a standard-of-care treatment, plus KEYTRUDA® (pembrolizumab) for patients with soft tissue sarcoma (STS).

媒体发布efti与放疗和抗PD-1治疗的新型三联疗法耐受性良好，并在EFTISARC-NEO II期临床试验中取得了令人鼓舞的初步疗效数据。六名接受治疗的患者的病理反应非常好，接近完全（研究的主要终点），在标准治疗中很少观察到。软组织肉瘤是一种预后不良且未满足医疗需求的难治性孤儿疾病。EFTISARC-NEO的其他数据计划于2024年5月2日在澳大利亚悉尼举行的医学会议（环球通讯社）——Immutep Limited（ASX:IMM；NASDAQ:IMMP）（“Immutep”或“the Company”），一个临床阶段生物技术公司开发了针对癌症和自身免疫性疾病的新型LAG-3免疫疗法，今天宣布了EFTISARC-NEO的初步令人鼓舞的数据，EFTISARC-NEO是eftilagimod alpha（efti）与放疗（一种标准治疗方法）以及KEYTRUDA®（pembrolizumab）联合进行的II期研究者发起的试验对于软组织肉瘤（STS）患者。

The EFTISARC-NEO study is the first to evaluate efti in a neoadjuvant setting, which takes place before intended surgery, and the first to combine efti with radiotherapy. Importantly, the neoadjuvant setting allows for the impact of this novel combination to be assessed in the tumour microenvironment (TME).

EFTISARC-NEO研究是第一个在新辅助治疗中评估efti的研究，该研究发生在预期手术之前，也是第一个将efti与放疗相结合的研究。重要的是，新辅助设置允许在肿瘤微环境（TME）中评估这种新型组合的影响。

The triple combination has revealed no new safety findings and has been well tolerated in the first six patients who have completed the 10 weeks of treatment followed by surgery 2-3 weeks later. Initial efficacy data is very encouraging with 4 of 6 patients (67%) having near-complete responses according to EORTC-STBSDG, which measures responses via tissue pathology after surgery.

三联疗法没有发现新的安全性发现，并且在完成10周治疗并在2-3周后进行手术的前6名患者中耐受性良好。根据EORTC-STBSDG，最初的疗效数据非常令人鼓舞，其中6名患者中有4名（67%）具有接近完全的反应，EORTC-STBSDG通过手术后的组织病理学测量反应。

These deep responses are rarely seen in STS patients with standard therapeutic appr.

这些深度反应在标准治疗appr的STS患者中很少见。