Immutep Hits Midpoint in NSCLC Trial, Eyes Key Milestones
Event summary
- Immutep's TACTI-004 Phase III trial in 1L NSCLC reaches 50% enrollment with 378 patients across 27 countries.
- Futility analysis scheduled for Q1 2026, full enrollment expected by Q3 2026.
- Trial evaluates eftilagimod alfa (efti) combined with KEYTRUDA and chemotherapy.
- Over 140 clinical sites activated globally for the study.
The big picture
Immutep's progress in the TACTI-004 trial positions eftilagimod alfa as a potential game-changer in 1L NSCLC, a high-mortality indication with significant unmet needs. The combination therapy's ability to expand anti-PD-1 response across PD-L1 levels could redefine treatment standards. Success here would validate Immutep's MHC Class II agonist platform, opening doors to broader applications in oncology.
What we're watching
- Trial Execution
- Whether the robust enrollment pace can be sustained through Q3 2026.
- Regulatory Pathway
- How the FDA's Fast Track designation will influence potential approval timelines.
- Competitive Dynamics
- The impact of TACTI-004's results on the 1L NSCLC treatment landscape.
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