Immutep Reports Strong Global Progress and Ongoing Enrolment in TACTI-004 Phase III Trial
Reuters
Dec 16, 2025
Immutep Reports Strong Global Progress and Ongoing Enrolment in TACTI-004 Phase III Trial
Immutep Ltd. announced strong operational progress in its global TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD's KEYTRUDA® (pembrolizumab) and chemotherapy as first-line therapy for advanced/metastatic non-small cell lung cancer. As of December 16, 2025, the trial has enrolled 289 patients, representing over 38% of the targeted enrolment of 756 patients. The number of activated clinical sites now exceeds 120, and 27 countries, including the United States, have received full regulatory approvals. The necessary 170 patients for the futility analysis have been enrolled, with the analysis scheduled for the first quarter of calendar year 2026. Completion of patient enrolment is expected in the third quarter of calendar year 2026.
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