Karim Chamie, MD, discusses the design of the phase 2/3 QUILT-3.032 trial in patients with Bacillus Calmette-Guerín–unresponsive, non–muscle invasive bladder cancer carcinoma in situ.
Karim Chamie, MD, associate professor, Urology, UCLA Health, discusses the design of the phase 2/3 QUILT-3.032 trial (NCT0302282) in patients with Bacillus Calmette-Guerín (BCG)–unresponsive, non–muscle invasive bladder cancer carcinoma in situ.
BCG-unresponsive bladder cancer is not a disease that is common, and because of this, the FDA approves drugs that have achieved certain milestones, according to Chamie. For example, phase 3 trials where patients are randomized to placebo or the study drug are not necessary in the patient population. Instead, the FDA has allowed companies to develop single-arm studies in which every patient receives the investigational agent, Chamie adds.
As such, in the single-arm QUILT-3.032 study, every patient received N-803 plus BCG, Chamie concludes. At the 2021 AUA Annual Meeting, data from the interim analysis of cohort A of the trial, which was comprised of patients with BCG-unresponsive NMIBC carcinoma in situ (CIS). The primary end point of this cohort was incidence of complete response of CIS at any time, and it was met.