Logo image
Back
IP20-17 INTERIM ANALYSIS OF LIGHT-ACTIVATED TLD-1433 IN A PHASE II CLINICAL STUDY OF BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER CARCINOMA IN-SITU
Abstract   Peer reviewed

IP20-17 INTERIM ANALYSIS OF LIGHT-ACTIVATED TLD-1433 IN A PHASE II CLINICAL STUDY OF BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER CARCINOMA IN-SITU

Girish S. Kulkarni, Peter C. Black, Kyle Richards, Gautam Jayram, Ricardo Rendon, Piyush K. Agarwal, Neal Shore, Brant Inman, Daniel Saltzstein, Eugene Kramalowsky, …
The Journal of urology, Vol.215(5S), p.e425
05/2026
DOI: 10.1097/01.JU.0001191388.74345.c9.17

View Online

Abstract

INTRODUCTION AND OBJECTIVES: Bladder sparing therapies are actively being investigated for BCG-Unresponsive, Non-Muscle Invasive Bladder Cancer (NMIBC). We report on the interim results of a Phase II clinical study of a light-activated small molecule, Ruvidar® (Photodynamic Therapy, PDT), in patients with BCG-Unresponsive NMIBC Carcinoma In-Situ (+/- papillary disease). METHODS: Patients were accrued at 11 centers in Canada and the United States. Therapy consisted of an intravesical instillation of Ruvidar® (0.70 mg/cm2) followed by intravesical laser light activation (520 nm, 90 J/cm2) under anesthesia. Early in the study, PDT was administered at Day 0 and at Day 180 regardless of recurrence; however, the clinical protocol was revised to provide a single PDT at Day 0 and up to two additional PDT procedures should a high risk NMIBC recurrence occur. The primary endpoint was Complete Response (CR) at any point in time. The secondary endpoint was duration of CR after initial CR. The tertiary endpoint was safety. All AEs were tracked for resolution. All CR analyses, for who the Sponsor received pathology samples, have been validated by central pathology. RESULTS: A total of 87/90 patients have been enrolled and treated in the study (Day 0). Of these patients, 82% were ≥ 65 years of age, 82% male and 83% white. Tumour stage was distributed as follows: pure 81% CIS; 13% CIS + T1; and 6% CIS + Ta. 94% were classified as BCG-Unresponsive with 6% BCG-Intolerant. The median number of BCG instillations was 15.5. CR at any time point occurred in 54/84 (64.3%; 95% CI 47.1-81.4) patients with at least one evaluation after treatment. One year duration of response beyond CR was noted in 18/45 (40%; 95% CI 23.1-56.9) patients with at least 450 days of follow up. The median duration of response was 14.2 months [95% CI: 11.1, 17.3]. Extended follow up demonstrated duration of CR of 22.2% (10/45) at 2 years and 20.0% (9/45) at 3 years. On Kaplan-Meier analysis, if CR is obtained, the long term estimated probability of remaining cancer free at 1, 2 and 3 years was 48.7%, 35.9% and 25.2%, respectively. Treatment Emergent Adverse Events were noted but did not meet the SAE criteria. These included urinary frequency (65%), hematuria (62.5%) and urinary urgency (53.8%) which usually resolved within 1 month of treatment. 21 (24%) reported Serious Adverse Events have been documented: 1 x Grade I, 3 x Grade II, 12 x Grade III, 3 x Grade IV (all resolved from between 1 to 82 days) and 1 x Grade V, most of which were not Treatment Emergent. CONCLUSIONS: The interim results support light-activated Ruvidar® as a viable treatment option for patients with BCG-Unresponsive NMIBC CIS (+/- papillary disease) with an acceptable safety profile.

Details

Metrics

1 Record Views
Logo image