WCLC 2025 - Posters & ePosters-P3.18.34 TACTI-004, a Phase 3 Trial of Eftilagimod Alfa Plus Pembrolizumab (P) + Chemotherapy (C) vs Placebo + P + C in 1St Line NSCLC

P3.18.34 TACTI-004, a Phase 3 Trial of Eftilagimod Alfa Plus Pembrolizumab (P) + Chemotherapy (C) vs Placebo + P + C in 1St Line NSCLC

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The TACTI-004 trial (NCT06726265; KEYNOTE-F91) is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study evaluating the efficacy and safety of eftilagimod alfa (efti) combined with pembrolizumab (P) plus chemotherapy (C) versus placebo with P plus C in first-line treatment of advanced/metastatic non-small cell lung cancer (NSCLC). Efti is an antigen-presenting cell (APC) activator that enhances immune responses by activating T cells and other immune effectors, promoting tumor cell destruction.<br /><br />Building on encouraging safety and efficacy data from earlier studies (TACTI-002, INSIGHT-003), which showed promising antitumor activity regardless of PD-L1 expression levels, TACTI-004 aims to confirm these effects in a larger cohort. The study plans to enroll about 756 subjects across 25 countries, including patients with squamous and non-squamous advanced NSCLC who are naive to systemic therapy, have ECOG performance status 0-1, and lack targetable mutations (EGFR, ALK, ROS1).<br /><br />Participants will be randomized 1:1 to receive either efti plus pembrolizumab and chemotherapy or placebo with pembrolizumab and chemotherapy. Efti is administered subcutaneously at 30 mg every two weeks for six months, then every three weeks up to two years; pembrolizumab at 200 mg intravenously every three weeks for up to two years; chemotherapy is platinum-based, histology-specific.<br /><br />The dual primary endpoints are progression-free survival (PFS) and overall survival (OS), assessed by RECIST 1.1. Secondary endpoints include objective response rate (ORR), safety, duration of response, disease control rate, time to response, and quality of life. Exploratory objectives involve detailed immunogenic and pharmacokinetic evaluations.<br /><br />This trial investigates whether adding efti—a novel APC activator—can enhance the anti-tumor efficacy of pembrolizumab plus chemotherapy, potentially improving clinical outcomes for NSCLC patients across all PD-L1 expression levels. The study is currently enrolling participants, with interim analyses planned and final evaluation to assess superiority primarily on OS. For further details, the trial is registered at clinicaltrials.gov (NCT06726265).

Asset Subtitle

Martin Sebastian

Meta Tag

Speaker Martin Sebastian

Topic Clinical Trials in Progress

Keywords

TACTI-004 trial

eftilagimod alfa

pembrolizumab

chemotherapy

non-small cell lung cancer

antigen-presenting cell activator

immune response

phase 3 clinical trial

progression-free survival

overall survival