Optimal Management of Bacillus Calmette-Guérin–Refractory No Photodynamic Therapy
In 2023, interim findings were released, detailing the outcomes of a phase 2 clinical study on intravesical photodynamic therapy for patients with BCG-unresponsive CIS with or without papillary disease (NCT03945162) [42]. The study involved intravesical instillation of the photosensitizer TLD-1433 (0.70 mg/cm2), followed by activation using a 520-nm intravesical laser (Study Device TLC-3200) and consequently delivering a total of 90 J/cm2 of laser light under general anesthesia. Among the 45 enrolled patients, the data showed CR rates of 50% at 90 days, 35% at 360 days, and 21% at 450 days. Eight serious adverse events were identified in the study. The study is currently ongoing, with recruitment in progress, and the estimated completion date is December 2025.
Optimal Management of Bacillus Calmette-Gurin–Refractory Non–Muscle-Invasive Bladder Cancer in 2023 (e-juo.org)