zalifrelimab + imiquimod

Zalifrelimab + imiquimod is a combination investigational therapy comprised of zalifrelimab (UGN-301), a fully human monoclonal antibody targeting CTLA-4, and imiquimod (UGN-201), a small molecule Toll-like receptor 7 (TLR7) agonist. The combination is being developed for intravesical administration (directly into the bladder) to treat recurrent non-muscle invasive bladder cancer (NMIBC), particularly in patients who are unresponsive to or unsuitable for Bacillus Calmette-Guérin (BCG) therapy. The therapeutic rationale is to pair immune checkpoint inhibition (via anti-CTLA-4 action) with innate immune activation and local antitumor responses (via TLR7 agonism), aiming to enhance the immune-mediated elimination of bladder cancer cells.[3]