Immutep Limited (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotechnology company, has announced significant progress in its LAG-3 immunotherapy program, particularly with its lead product candidate, eftilagimod alfa (efti). The company's Q2 FY25 activities report highlights advancements across multiple clinical trials and regulatory milestones.
Phase III Transition with TACTI-004 in 1L NSCLC
A major highlight is the initiation of the pivotal TACTI-004 Phase III clinical trial of efti for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC). The Australian Therapeutic Goods Administration's regulatory approval marks Immutep's transition into a Phase III company. This global trial, involving over 25 countries, is expected to enroll its first patient in Q1 CY2025.
INSIGHT-003: Impressive Survival Data in 1L NSCLC
Mature data from the investigator-initiated INSIGHT-003 trial, evaluating efti in combination with KEYTRUDA (pembrolizumab) and doublet chemotherapy for 1L NSCLC, demonstrated a median overall survival (OS) of 32.9 months and a 24-month OS rate of 81.0% (N=21), significantly exceeding historical controls. Data from all evaluable patients (N=40) also showed a marked improvement in objective response rate (ORR) compared to historical controls, with a favorable safety profile.
TACTI-003: Promising Results in Head and Neck Cancer
Further positive results were reported from Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial, evaluating efti in combination with pembrolizumab as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (1L HNSCC) patients with PD-L1 negative tumors (CPS <1). Presented at the ESMO Immuno-Oncology (IO) Annual Congress 2024, the data showed that median overall survival (OS) has not yet been reached, and the 12-month OS rate is 67%. Additional findings included a progression-free survival (PFS) of 5.8 months, an interim median duration of response (DOR) of 9.3 months, a 35.5% objective response rate (ORR), and a 58.1% disease control rate (DCR).
EFTISARC-NEO: Efficacy in Soft Tissue Sarcoma
New data from the EFTISARC-NEO Phase II trial of efti in combination with radiotherapy plus pembrolizumab for soft tissue sarcoma (STS) were presented at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting. Preliminary analysis suggests significant efficacy in the neoadjuvant setting for resectable STS, with a greater than three-fold increase in tumor hyalinization/fibrosis (median 50%) compared to historical data from radiotherapy alone (median 15%). The trial also showed that 71.4% of patients achieved a pathologic response, defined as ≥35% of hyalinization/fibrosis, and 9.5% of patients achieved a complete pathologic response. The triple combination therapy was safe, with no grade ≥3 toxicities related to efti and KEYTRUDA.
IMP761: Advancing Autoimmune Disease Treatment
Immutep is also advancing its IMP761 program for autoimmune diseases. Initial safety data from the Phase I study evaluating IMP761 showed favorable results, with no treatment-related adverse events in the first three single ascending dose cohorts in healthy participants. Further safety data and pharmacokinetic/pharmacodynamic (PK/PD) assessments are expected in the first half of CY2025.
Financial Position
Immutep reported a strong financial position with A$159.26 million in cash, cash equivalents, and term deposits as of December 31, 2024, providing an expected cash reach to the end of CY2026.
