KEY TAKEAWAYS
- The SunRISe-1 trial evaluates the efficacy and safety of TAR-200 + CET (Cohort 1 [C1]), TAR-200 alone (C2), or CET alone (C3) in BCG-unresponsive pts with HR NMIBC.
- The primary endpoint is the overall CR at any time point, the secondary endpoints being DOR, OS, PK, QoL, safety, and tolerability.
- The study shows a promising CR rate and safety profile with TAR-200 monotherapy, and CET results align with other anti-PD(L)1 tx in this setting.
The ongoing phase 2 SunRISe-1 study enrolled patients (pts) ≥18 y who had confirmed CIS±papillary disease (T1, high-grade Ta), had received appropriate bacillus calmette-guerin (BCG) ≤12 mo before enrollment, and had an ECOG performance status of 0-2. The pts were randomized to TAR-200 + CET (Cohort 1 [C1]), TAR-200 alone (C2), or Cetrelimab (CET) alone (C3). TAR-200 was administered Q3W through Wk 24, then Q12W until Wk 96. CET was given through Wk 78.The study assessed disease response using cystoscopy, centrally read urine cytology, CT/MRI, and TURBT (bladder biopsy) at baseline and prespecified time points. The primary objective was to determine the complete response (CR) rate at any time point. The secondary endpoints were duration of response (DOR), overall survival (OS), PK, quality of life (QoL), safety, and tolerance.
According to the data cutoff on May 25, 2022, 13 pts in C2 and 13 in C3 (median 71.5 y [range 51-88]) received treatment. The efficacy evaluable set included 8 pts in C2 and 8 in C3. Moreover, the centrally confirmed CR by urine cytology and/or biopsy was 88% (95% CI 47-100) in C2 and 38% (9-76) in C3. After a median follow-up of 13.6 and 12.0 weeks, the median CR duration of response for C2 and C3 was not reached. At the data cutoff, 7 out of 8 pts in C2 remained in CR, with three ongoing responses lasting more than six months (ranging from 7.7-9.4 months).
In the study, 11 pts (85%) in C2 and 8 pts (62%) in C3 experienced tx-emergent adverse events (TEAEs). However, most of these events were classified as Gr 1-2. The most common TEAEs in C2 were pollakiuria, micturition urgency, and noninfective cystitis, each occurring in 39% of patients. In C3, the most common TEAEs were fatigue and lipase increased, each occurring in 23% of patients. Gr ≥3 TEAEs were reported in 1 patient (8%) in C2 and 2 pts (15%) in C3, which were tx-related. Additionally, one serious TEAE (myocarditis) was reported in C3.
The initial findings from SunRISe-1 indicated a promising CR rate and a safe profile when using TAR-200 as a monotherapy. Additionally, the CET results were consistent with other anti-PD(L)1 treatments in this setting. Based on the preliminary data on both efficacy and safety, further studies on NMIBC are warranted.
Source: https://www.auajournals.org/doi/10.1097/JU.0000000000003361.03
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04640623
Daneshmand, Siamak; van der Heijden, Michiel S; Jacob, Joseph M; Necchi, Andrea; Xylinas, Evanguelos; Morris, David S; Spiegelhalder, Philip; Zainfeld, Daniel; Kang, Taek Won; Matulay, Justin T; Belkoff, Laurence H; Decaestecker, Karel; Arentsen, Harm; Hampras, Shalaka; Jin, Shu; Cutie, Christopher J; Sweiti, Hussein; Stromberg, Katherine; Martin, Jason; Simone, Giuseppe LBA02-03 FIRST RESULTS FROM SunRISE-1 IN PATIENTS WITH BCG UNRESPONSIVE HIGH-RISK NON–MUSCLE-INVASIVE BLADDER CANCER RECEIVING TAR-200 IN COMBINATION WITH CETRELIMAB, TAR-200, OR CETRELIMAB ALONE, Journal of Urology: April 2023 – Volume 209 – Issue Supplement 4
doi: 10.1097/JU.0000000000003361.03
