Immutep Limited announced the Independent Data Monitoring Committee recommended discontinuation of the TACTI-004 Phase III study evaluating eftilagimod alfa in first-line NSCLC following a futility analysis. Enrollment will halt with an orderly wind down, data review underway, extending cash runway beyond prior Q2 CY2027 guidance.
Key takeaways
IDMC recommended discontinuation of TACTI-004 Phase III trial for futility after interim analysis
Trial evaluated eftilagimod alfa + pembrolizumab + chemotherapy vs placebo + pembrolizumab + chemotherapy in 1L NSCLC
Planned enrollment of approximately 756 patients at over 150 sites in over 25 countries
Enrollment halted; orderly wind down including patient follow-up and site close-out
Cash runway extended well beyond previously guided Q2 CY2027 timeframe
Comprehensive data review to determine next steps for efti program