ESMO 2025 | SunRISe-4: primary and biomarker results of TAR-200 & cetrelimab in MIBC
Andrea Necchi, MD, IRCCS San Raffaele Hospital and Scientific Institute, Milan, Italy, discusses the Phase II SunRISe-4 trial (NCT04919512) of neoadjuvant cetrelimab with or without TAR-200, a gemcitabine-releasing intravesical system, in patients with muscle-invasive bladder cancer (MIBC) ineligible for cisplatin. The combination demonstrated higher rates of complete and overall pathologic responses and improved 1-year recurrence-free survival versus cetrelimab alone. Exploratory analyses highlight urinary and circulating tumor DNA as promising biomarkers for residual disease and treatment outcomes in this setting. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
SunRISe-4 trial was a trial testing the combination of gemcitabine intravesical system TAR-200 and cetrelimab or cetrelimab monotherapy for four courses every three weeks before radical cystectomy in patients with clinical T2, T3, M0, muscle-invasive bladder cancer who are ineligible for or refuse cisplatin-based chemotherapy. The interim results have been presented last year in our session at ESMO, published a few months ago in Lancet Oncology, and here we presented the primary findings and biomarker results...
SunRISe-4 trial was a trial testing the combination of gemcitabine intravesical system TAR-200 and cetrelimab or cetrelimab monotherapy for four courses every three weeks before radical cystectomy in patients with clinical T2, T3, M0, muscle-invasive bladder cancer who are ineligible for or refuse cisplatin-based chemotherapy. The interim results have been presented last year in our session at ESMO, published a few months ago in Lancet Oncology, and here we presented the primary findings and biomarker results. Primary findings actually confirm the initial findings. 38% of the patients achieved the pathological complete response with TAR-200, as compared to 28%. And the response, major pathological response, was as high as higher than 50%. So quite promising and confirming the initial findings. No new safety signals emerged at the primary analysis. And most importantly, we got the initial data on biomarkers focusing on the urinary tumor DNA, and circulating tumor DNA, that were assessed at the baseline, and at week 12, post-neoadjuvant therapy, just before cystectomy. First, urinary tumor DNA. Urinary tumor DNA at week 12, so post-treatment, emerged as a strong biomarker predicting pathological complete response in radical cystectomy. First, the clearance of the circulating tumor DNA in patients who had the pre-post comparison of the samples was also associated with pathological complete response. Interestingly, circulating tumor DNA, which was confirmed to be clearly associated with relapse-free survival, so survival outcomes, longer-term outcomes, was not associated with the interim endpoint of pathological response. So the results combined, the treatment standpoint of combination therapy and the biomarker standpoint of urinary tumor DNA and circulating tumor DNA are pretty well manageable because they are putting each one one single step towards a potential improvement in the management of these patients regarding treatment and regarding the potential for predicting pathological response with urinary tumor DNA and outcome with circulating tumor DNA. So the ideal setting, the ideal premise, I think, for the next generation bladder-sparing approaches.
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