Videos

Mark D. Tyson II, MD, MPH, contextualizes the cretostimogene data within the broader BCG-unresponsive NMIBC treatment landscape, addresses the methodologic limitations of cross-trial comparison, discusses the heavily pretreated nature of the BOND-003 population, reviews his approach to treatment sequencing across available bladder-sparing options, and offers his central take-home message for urologists managing high-risk BCG-unresponsive disease.

Mark D. Tyson II, MD, MPH, reviews the safety and tolerability profile of cretostimogene in BOND-003, including the absence of grade 3 or higher treatment-related adverse events, a 97% protocol completion rate, and the practical workflow considerations that would govern administration of cretostimogene in a urology practice if the agent receives FDA approval.

The phase 3 CAPItello-281 trial (NCT04493853) met its primary end point by showing that the addition of capivasertib (Truqap) to abiraterone (Zytiga) and prednisone significantly improved radiographic progression-free survival (rPFS) vs abiraterone and prednisone alone in patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC).

Mark D. Tyson II, MD, MPH, presents the efficacy results from BOND-003, Cohort C, including the 75.5% complete response rate at any time point, durability outcomes at 12 and 24 months, a median duration of response of 27.9 months, re-induction conversion data, and cystectomy-free survival rates of 89.2% and 81.3% at 12 and 24 months, respectively.

Mark D. Tyson II, MD, MPH, describes the design of the phase 3 BOND-003 trial, Cohort C, including the patient eligibility criteria, induction and maintenance dosing schedule, the clinical rationale and immunologic basis for allowing reinduction in patients with persistent disease at 3 months, and the definition and significance of the primary end point.