Immutep’s Clinical Trial Reaches Critical Recruitment Milestone
07.02.2026 - 20:26:04
Immutep has reported significant progress in its late-stage clinical development program. The biotechnology firm announced that patient enrollment for its pivotal Phase III trial, known as TACTI-004, has crossed the halfway mark. This achievement keeps the company's timeline for an initial data readout within the current quarter firmly on track.
The global TACTI-004 study, also designated KEYNOTE-F91, is a cornerstone of Immutep's current pipeline. The trial is evaluating a combination therapy for first-line treatment of metastatic non-small cell lung cancer (NSCLC). It has now enrolled 378 participants, representing 50% of its total target of approximately 756 patients across more than 140 sites in 27 countries.
The therapeutic approach combines Immutep's lead candidate, Eftilagimod alpha (Efti), with MSD's established immunotherapy Keytruda and a standard chemotherapy regimen. A primary objective is to demonstrate efficacy regardless of a patient's PD-L1 status, which could substantially expand the potential addressable market for the treatment by establishing a new standard of care.
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Management has reaffirmed its projected schedule for key clinical milestones following this recruitment update. Investor attention is now turning to the first quarter of 2026, when a planned futility analysis is scheduled. This interim assessment is designed to provide an early evaluation of the study's overall viability and safety profile.
The news arrives amid positive momentum for the company's shares. Between December and early February, Immutep's stock listed on the NASDAQ recorded a gain of approximately 43%. Prior to this announcement, the share price was trading around $2.62. Adherence to this timeline is viewed as crucial, as any delays in a Phase III study can significantly increase capital expenditure. Full patient recruitment is anticipated by the third quarter of 2026.
Key Trial Metrics:
* Current Enrollment: 378 patients
* Total Recruitment Goal: ~756 patients
* Next Major Milestone: Futility analysis (Q1 2026)
* Expected Recruitment Completion: Q3 2026
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