Immutep Surpasses Enrollment Milestone in Pivotal Lung Cancer Trial
Immutep Limited has enrolled over 170 patients in its global Phase III TACTI-004 trial for advanced non-small cell lung cancer, surpassing the threshold needed for a futility analysis expected in early 2026.
- TACTI-004 Phase III trial exceeds 170 patient enrollment
- Over 100 clinical sites activated across 24 countries
- Futility analysis scheduled for first quarter of 2026
- Eftilagimod alfa combined with KEYTRUDA and chemotherapy
- Previous studies show promising efficacy regardless of PD-L1 status
Trial Progress and Significance
Immutep Limited, a biotechnology company focused on immunotherapies, has announced a key milestone in its Phase III TACTI-004 trial targeting first-line treatment for advanced or metastatic non-small cell lung cancer (NSCLC). The trial has now enrolled and randomized over 170 patients, surpassing the number required to conduct a futility analysis. This analysis, which will be performed by an independent data monitoring committee, is on track for completion in the first quarter of 2026.
NSCLC represents the majority of lung cancer cases worldwide and remains a leading cause of cancer mortality. Current treatment options are limited, especially for patients diagnosed at advanced stages, making the development of effective therapies a critical unmet need.
Global Reach and Trial Design
The TACTI-004 trial is a large-scale, randomized, double-blind study involving over 100 activated clinical sites across 24 countries. It evaluates the combination of Immutep’s novel immunotherapy eftilagimod alfa (efti) with Merck’s anti-PD-1 therapy KEYTRUDA and chemotherapy. The trial aims to enroll approximately 756 patients regardless of PD-L1 expression, reflecting a broad patient population.
Efti is designed to activate antigen-presenting cells through the MHC Class II pathway, stimulating a robust immune response against cancer cells. Previous Phase II studies, including TACTI-002 and INSIGHT-003, have demonstrated that efti enhances the efficacy of KEYTRUDA, leading to higher response rates and improved progression-free survival.
Expert Commentary and Outlook
Immutep’s CEO Marc Voigt highlighted the rapid enrollment pace as a positive indicator of the trial’s potential impact on the NSCLC treatment landscape. The company’s Chief Medical Officer, Dr. Stephan Winckels, noted strong engagement with the lung cancer medical community and favorable feedback on the trial design and efti’s innovative mechanism.
With lung cancer incidence projected to rise globally, the successful development of new therapies like efti could address significant gaps in treatment efficacy and patient survival. The upcoming futility analysis will be a critical checkpoint to assess whether the trial should continue as planned.
Bottom Line?
As Immutep advances toward its futility analysis, the oncology community watches closely for signs of a breakthrough in lung cancer treatment.
Questions in the middle?
- Will the futility analysis confirm efti’s added benefit to KEYTRUDA and chemotherapy?
- How might enrollment trends influence the trial’s timeline and data robustness?
- What are the competitive implications if TACTI-004 delivers positive overall survival results?
