Status:
Completed
Clinicaltrials.gov identifier:
Sponsor:
Janssen Research & Development, LLC
Study Design:
Phase 2b, multi-center study randomizing BCG-unresponsive high risk non-muscle invasive bladder cancer with CIS with or without papillary disease randomized 2:1:1 (by presence or absence of papillary disease) to TAR-200 + cetrelimab, TAR-200 alone, or cetrelimab alone.
Rationale:
Patients with BCG unresponsive disease have limited treatment options. They may respond to the sustained release of gemcitabine through the use of a novel intravesical delivery system, TAR-200, either alone or in combination with a PD-1 antibody, cetrelimab. In addition, the trial evaluates the effect of cetrelimab alone as well.
Endpoints:
The primary endpoint was complete response (CR) rate. The secondary endpoints were duration of response, overall survival, pharmacokinetics, and safety/tolerability.
Comments:
The cetrelimab alone response rates are in line with what has been seen with pembrolizumab alone. However, TAR-200 responses were impressive and higher than seen with gemcitabine dosed in a usual intravesical fashion. However, toxicity was worse but consisted of local symptoms that are grade 1-2 in nature.
Results:
The data from the two monotherapy arms was presented from a planned interim analysis. Seventy-three (73%) of patients in the TAR-200 arm achieved a CR while the CR rate was 38% in the cetrelimab arm. Grade greater than or equal to 3 adverse events (AEs) in TAR-200 group was 30% compared to 8% in the cetrelimab group. Of note, 15 of the 16 CRs in the TAR-200 group were still ongoing at the median follow-up of 11 months.
