Immutep Limited announced that its Independent Data Monitoring Committee has recommended discontinuing the TACTI‑004 Phase III study in first‑line non‑small cell lung cancer, ending enrollment and initiating a structured wind‑down of the trial.
TACTI‑004 was a randomized, double‑blind, controlled study that enrolled approximately 756 patients across more than 150 sites in 25 countries. The trial evaluated eftilagimod alfa (efti) in combination with MSD’s KEYTRUDA® and chemotherapy, with dual primary endpoints of progression‑free survival and overall survival. At the time of the halt, enrollment had reached roughly 50% of the target population.
The decision to stop the trial reduces Immutep’s research and development expenditures and is expected to extend the company’s cash runway beyond the previously guided Q2 2027. The company’s cash and term deposits were $99.1 million at the end of 2025, and an additional $29.9 million upfront payment from a licensing agreement with Dr. Reddy’s Laboratories in January 2026 further strengthens liquidity.
CEO Marc Voigt expressed disappointment and surprise at the outcome, noting that efti had performed well in other clinical programs. He said the company will conduct a comprehensive review of the data and reassess capital allocation priorities.
Investors reacted negatively to the announcement, and the company’s shares were suspended on March 6 pending the outcome of the futility analysis. Analysts have expressed concerns about the impact of the trial’s discontinuation on Immutep’s valuation and future prospects.
The TACTI‑004 trial was the company’s flagship program; its discontinuation removes the primary value driver and has pushed Immutep’s market capitalization below its net cash position. The setback also adds to the challenges facing the LAG‑3 therapeutic class, which has seen recent clinical failures.
Immutep remains focused on advancing its pipeline, including the Phase III TACTI‑3 program and earlier‑stage studies in head and neck cancer, breast cancer, soft tissue sarcoma, and autoimmune diseases. The company will evaluate the data from the halted trial and determine the next steps for its remaining programs, while the extended cash runway provides a buffer for continued development.
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