Immutep Limited (ASX: IMM; NASDAQ: IMMP) has announced that new data from the EFTISARC-NEO Phase II trial, evaluating eftilagimod alpha (efti) in combination with radiotherapy and KEYTRUDA® (pembrolizumab) for patients with soft tissue sarcoma (STS), will be presented at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting in San Diego, California.
The EFTISARC-NEO trial is a Phase II investigator-initiated study and the first to evaluate efti in a neoadjuvant setting for STS. This approach allows researchers to access tumor tissue before and after treatment, providing valuable insights into efti's impact on the tumor microenvironment.
Promising Initial Efficacy Data
Initial efficacy data from the novel triple combination, reported in May 2024, demonstrated encouraging results in the first six patients. The majority of these patients experienced deep responses, which are rarely observed in STS patients treated with standard therapeutic approaches.
Soft Tissue Sarcoma: An Unmet Need
STS is a rare orphan disease with a poor prognosis and significant unmet medical needs. The incidence of STS varies across Europe, with approximately 23,400 cases reported annually, according to the RARECARE project. In the United States, the American Cancer Society estimates that there will be approximately 13,590 new STS cases and 5,200 deaths in 2024.
Trial Design and Funding
The open-label EFTISARC-NEO Phase II study will enroll up to 40 patients and is being conducted by the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw. The trial is primarily funded by a grant from the Polish government awarded by the Polish Medical Research Agency program. The trial is registered on clinicaltrials.gov (NCT06128863).
Presentation Details
The preliminary results from the Phase 2 EFTISARC-NEO trial will be presented in a poster presentation by Pawel Sobczuk, M.D., Ph.D., from the Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, on Thursday, November 14, 2024.
Immutep plans to announce the data to the ASX and make the poster presentation available on its website following the CTOS 2024 presentation.
