Immutep Discontinues TACTI-004 Phase III Trial Due to Futility
Immutep announced the discontinuation of its TACTI-004 Phase III trial for first-line non-small cell lung cancer (1L NSCLC) following an independent data monitoring committee's recommendation due to futility. The eftilagimod alfa arm unexpectedly underperformed the control arm, leading to an orderly wind-down of the study. A root cause analysis is underway to understand the outcome and its implications for the broader eftilagimod alfa development program. Despite this setback, the company's IMP761 Phase I trial for autoimmune diseases is progressing with a favorable safety profile, and other efti trials continue. Immutep reported a strong cash position of A$110.6 million as of March 31, 2026, providing an expected cash reach into H1 CY2028, though it faces a US$10 million payment obligation to Dr. Reddy's related to the trial discontinuation and has initiated cost reduction measures.
Key Highlights
- Immutep discontinued the TACTI-004 Phase III trial for 1L NSCLC due to futility after interim analysis.
- Patients in the efti arm underperformed compared to the control arm in TACTI-004.
- Root cause analysis for TACTI-004 is ongoing, with implications for the broader eftilagimod alfa program under review.
- IMP761 Phase I trial for autoimmune diseases demonstrated a favorable safety profile and is progressing to multiple ascending dose phase.
- Cash, cash equivalents, and term deposits totaled A$110.6 million as of March 31, 2026.
- The company expects its cash runway to extend into H1 CY2028 based on current assumptions.
- Immutep has a US$10 million payment obligation to Dr. Reddy's by June 2026 due to the TACTI-004 discontinuation.
- Cost reduction measures, including headcount reduction, have been initiated to preserve capital.