IMM.ASX: TACTI-004 phase III trial enrolment continues at robust pace

TACTI-004 phase III trial enrolment continues at robust pace

Stock	Immutep Ltd (IMM.ASX)
Release Time	16 Dec 2025, 8:34 a.m.
Price Sensitive	Yes

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Immutep announces robust progress in TACTI-004 phase III trial

Key Points

TACTI-004 phase III trial has enrolled 289 patients globally, over 38% of the targeted enrolment
Strong operational progress with over 120 activated clinical sites and 27 countries having received full regulatory approvals
Futility analysis remains on track for Q1 2026 and completion of patient enrolment in Q3 2026

Full Summary

Immutep Limited has reported strong operational progress in the TACTI-004 (KEYNOTE-F91) phase III trial evaluating eftilagimod alfa (efti) in combination with Merck's anti-PD-1 therapy, KEYTRUDA, and chemotherapy as first-line therapy for advanced/metastatic non-small cell lung cancer. The registrational TACTI-004 trial has enrolled 289 patients, over 38% of the trial's targeted enrolment of 756 patients, and enrolment continues at a robust pace. Additionally, the number of activated clinical sites now exceeds 120 and 27 countries have received full regulatory approvals, including the United States. The futility analysis remains on track for the first quarter of 2026, and Immutep expects to complete patient enrolment in the third quarter of 2026. Immutep's CEO, Marc Voigt, expressed the company's excitement about the strong operational progress and the upcoming key milestones, including the futility analysis and completion of patient enrolment.