The year 2024 has been pivotal for bladder cancer research and treatment, with several key developments offering new hope to patients. Among the highlights is the FDA approval of N-803 (Anktiva, nogapendekin alfa inbakicept-pmln), a first-in-class IL-15 receptor agonist immunotherapy, for use in combination with BCG for treating BCG-unresponsive NMIBC with carcinoma in situ. This approval marks a significant step forward in immunotherapy for bladder cancer.
Another promising development is the exploration of TAR-200, a novel investigational treatment for NMIBC, discussed by Mark D. Tyson, MD, MPH. Additionally, the potential of Apalutamide in NMIBC was highlighted by Edward M. Messing, MD, based on a randomized trial presented at the 2024 American Urological Association Annual Meeting.
Blue light cystoscopy has also shown to decrease the risk of recurrence and progression in NMIBC, according to data from the BRAVO study. Furthermore, the phase 3 EV-302 trial results, published in the New England Journal of Medicine, demonstrated that the combination of enfortumab vedotin-ejfv (Padcev, EV) and pembrolizumab (Keytruda) extended overall survival and progression-free survival in patients with previously untreated locally advanced or metastatic urothelial carcinoma.
The FDA's acceptance of an investigational new drug application for RAG-01, a small activating RNA therapy for BCG-unresponsive NMIBC, and the initial promise shown by photodynamic therapy TLD-1433 in a phase 2 study, further underscore the year's advancements in bladder cancer treatment. These developments collectively represent a significant leap forward in the fight against bladder cancer, offering new avenues for treatment and hope for patients.
