Immutep Completes Enrolment Of 40 Patients In Phase II EFTISARC-NEO Trial Evaluating Efti With Radiotherapy And KEYTRUDA For Soft Tissue Sarcoma; Data Updates Expected In 2025; Achieved A Three-Fold Increase In Tumour Hyalinization/Fibrosis; No Grade ≥3 Toxicities Reported

Benzinga·01/22/2025 13:08:16

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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 50%) at the time of surgical resection as compared to a historical median 15% from radiotherapy alone. This is an early surrogate endpoint at the time of surgery as tumour hyalinization/fibrosis has been associated with improved survival for STS patients.1,2

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).

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