Immutep (ASX: IMM) has achieved a significant milestone, announcing 50% patient enrolment in its global Phase III TACTI-004 trial for first-line non-small cell lung cancer (NSCLC).
This landmark, coupled with confirmed timelines for a key futility analysis and enrolment completion, de-risks the path towards pivotal data readouts.
Immutep has successfully enrolled 378 patients, reaching 50% of its 756-patient target for the global trial, which is active across over 140 sites in 27 countries.
This milestone demonstrates strong operational execution and indicates significant patient interest in the eftilagimod alfa combination therapy.
Futility Analysis and Enrolment Timelines Confirmed
The crucial futility analysis for the TACTI-004 trial is on track for Q1 CY2026. Furthermore, completion of patient enrolment is anticipated by Q3 CY2026.
These confirmed timelines provide clarity and de-risk the pathway to the availability of pivotal data, which is an important step in clinical development.
TACTI-004 evaluates eftilagimod alfa (efti) in combination with KEYTRUDA and chemotherapy for 1L NSCLC. Previous coverage has shown positive efficacy signals for efti combinations in various cancer indications.
A strategic collaboration with Dr. Reddy's (announced on 29 January 2026) previously provided Immutep with an upfront payment of AUD 30.2 million, extending the company's cash runway and supporting ongoing development.
Ongoing Risks and Funding Needs
Like many biotechnology companies, Immutep continues to incur substantial operating losses, requiring ongoing financing to fund its clinical programs.
Clinical trial success remains a significant risk, as there is no guarantee of efficacy or regulatory approval for any product candidate.
The company has faced recruitment challenges in some trials, highlighted by the discontinuation of the INSIGHT-005 urothelial cancer trial.
These factors underscore the inherent risks in drug development and the need for continued prudent financial management.
Immutep's Path to Data Readout
The 50% enrolment milestone in TACTI-004 is a significant de-risking event for Immutep, providing tangible progress towards pivotal data.
While the confirmed timelines for futility analysis and enrolment completion are positive, investors will remain focused on the company's continued ability to manage its substantial funding needs and navigate the inherent clinical and regulatory risks.
