Immutep Limited reported that its pivotal Phase III TACTI‑004 trial has enrolled 289 patients, a 38 % completion of the 756‑patient target for first‑line non‑small cell lung cancer. The milestone demonstrates the company’s ability to recruit at a pace that supports the planned futility analysis and full enrollment schedule.
The trial now operates at 120 clinical sites in 27 countries, with 27 U.S. sites having received full regulatory clearance under the FDA’s Project Optimus initiative. Project Optimus required early dose‑optimization studies, and Immutep’s agreement on a 30 mg optimal biological dose for eftilagimod alfa de‑risks the U.S. regulatory pathway and enables the opening of U.S. sites.
The 170‑patient threshold for the futility analysis is on track for completion in the first quarter of 2026, and full enrollment is expected by the third quarter of 2026. Meeting these timelines is essential for the trial’s primary endpoints—progression‑free survival and overall survival—and for positioning the combination of eftilagimod alfa, KEYTRUDA, and chemotherapy for potential regulatory approval.
The enrollment progress is a key component of Immutep’s broader strategy to bring a first‑in‑class soluble LAG‑3 agonist to market. The recent licensing agreement with Dr Reddy’s for emerging‑market commercialization provides upfront cash and milestone payments that support the company’s cash runway while the trial advances. The deal also validates the commercial potential of eftilagimod alfa and allows Immutep to retain rights in major markets such as North America, Europe, and Japan.
Chief Executive Officer Marc Voigt said the company is “very pleased with the strong operational progress of TACTI‑004 globally and the robust pace of recruitment.” He added that the enrollment momentum, coupled with the Dr Reddy’s partnership, “positions Immutep to demonstrate the efficacy of eftilagimod alfa in a first‑line setting and to move closer to regulatory approval and partnership milestones.”
The milestone brings Immutep closer to the critical data points that will determine the commercial viability of its flagship platform and supports the company’s long‑term growth strategy in oncology.
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