Johnson & Johnson announces interim data from SunRISe-4 study

Johnson & Johnson announced interim data from the ongoing Phase 2 SunRISe-4 study showing neoadjuvant treatment with investigational TAR-200 plus cetrelimab, or CET, achieved nearly double the pathological complete response, or pCR, rate compared to CET alone in patients with muscle-invasive bladder cancer, or MIBC, who are ineligible or refuse neoadjuvant platinum-based chemotherapy and scheduled for radical cystectomy, or RC. These data were featured as a late-breaking oral presentation at the European Society of Medical Oncology. In the interim analysis of the SunRISe-4 study, neoadjuvant TAR-200 plus CET showed overall efficacy with a centrally confirmed pathologic complete response with CET alone in patients with histologically proven, non-metastatic MIBC. The pathological overall response rate was 60 percent compared to 36 percent, respectively. In a subgroup analysis of patients with organ-confined disease, or cT2, those treated with TAR-200 plus CET showed a 48% pCR rate compared to 23 percent pCR with CET alone and 68% were downstaged at the time of radical cystectomy, potentially improving surgical outcomes and reducing risk of recurrence. Treatment-related adverse events, or TRAEs, occurred in 72% of patients treated with TAR-200 combined with CET and 44% of patients treated with CET alone, with the majority being Grade 1-2. Nine percent of patients discontinued treatment with TAR-200 and eight percent discontinued treatment with CET in the combined treatment cohort due to TRAEs; no patients discontinued treatment due to TRAEs when treated with CET alone.