Immutep Accelerates Phase III TACTI-004 Trial, Enrolling Over 38% of Patients and Securing Approvals Across 27 Countries

Patient Enrolment Hits 38% Milestone Amid Broad Regulatory Success

Immutep Limited (ASX: IMM, NASDAQ: IMMP) has reached a significant checkpoint in its global Phase III TACTI-004 (KEYNOTE-F91) trial for advanced or metastatic non-small cell lung cancer. As of the latest update, the company has enrolled 289 out of its targeted 756 patients—more than 38%—while expanding operations to over 120 activated clinical sites in 27 countries. Notably, the United States is among the nations with full regulatory approvals, reflecting strong global interest and efficient site activation.

Futility Analysis and Full Enrolment Expected on Track for 2026

Progress has been marked not just by pace but also by clear planning. With 170 patients enrolled for the critical futility analysis, Immutep remains on schedule to deliver these interim results in the first quarter of 2026. Full trial enrolment is projected for the third quarter of 2026, signaling potential key readouts ahead that could reshape first-line treatment strategies for non-small cell lung cancer. The broad participation—across squamous and non-squamous subtypes and irrespective of PD-L1 expression—reflects the company’s ambition to address an expansive patient population.

Eftilagimod Alfa: Fast Track Status and Flexible Combination Therapy

The TACTI-004 trial investigates eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with MSD’s KEYTRUDA® (pembrolizumab) and chemotherapy. Efti has gained FDA Fast Track status for both head and neck squamous cell carcinoma and first-line NSCLC, emphasizing regulatory confidence in the asset’s potential. Efti’s novel mechanism—direct activation of antigen-presenting cells—aims to mobilize the body’s immune response more robustly against cancer, while its favorable safety profile allows for flexible use alongside immunotherapy, chemotherapy, and even radiotherapy.

CEO Highlights Strategic Partnerships and Robust Operational Momentum

Marc Voigt, Immutep’s CEO, underscored the positive impact of strategic deals, such as the recent efti licensing arrangement in emerging markets with Dr Reddy’s, and praised the operational momentum fueling continued site activation and rapid patient enrolment. He also emphasized upcoming milestones, including the highly anticipated futility analysis and eventual full enrolment.

What Investors Should Watch: Key Milestones Ahead

For those tracking the company, the combination of regulatory progress, rapid patient recruitment, and expanded clinical reach positions Immutep well for the next stages. The upcoming futility analysis in Q1 2026, followed by full enrolment in Q3 2026, represent major catalysts. The evolving clinical landscape—particularly with the TACTI-004 trial spanning more than 150 planned sites in 27+ countries—signals Immutep’s intent to be a prominent contender in immuno-oncology. Investors and observers will be watching closely for interim efficacy and safety results as the study progresses.

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