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ESMO 2025 | Molecular correlates of response to TAR-200 in BCG-unresponsive NMIBC

Felix Guerrero-Ramos, MD, PhD, Hospital Universitario 12 de Octubre in Madrid, Spain, discusses the Phase IIb SunRISe-1 trial (NCT04640623) of TAR-200 monotherapy in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. Analyses assessed baseline tumor genomic alterations, PD-L1 expression, tumor mutational burden, microsatellite instability, and urine tumor DNA minimal residual disease. Clinical responses to TAR-200 were observed across all molecular subtypes, with high rates of complete response and durable outcomes. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.

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Transcript

Well, we have presented this year a poster here at ESMO about the molecular markers predictors of response for CIS patients, which is cohort 2 of the SunRISe-1 trial, treated with TAR-200 only and who harbored BCG and responsive CIS with or without papillary disease. It is true that it is not a very large cohort, it’s a small cohort, and we found that over 85% of the patients have some kind of genomic alteration, although we didn’t find any association of any of the alterations with the clinical outcomes...

Well, we have presented this year a poster here at ESMO about the molecular markers predictors of response for CIS patients, which is cohort 2 of the SunRISe-1 trial, treated with TAR-200 only and who harbored BCG and responsive CIS with or without papillary disease. It is true that it is not a very large cohort, it’s a small cohort, and we found that over 85% of the patients have some kind of genomic alteration, although we didn’t find any association of any of the alterations with the clinical outcomes. The most frequent alteration was 50% of the patients with TP53, but as I said, probably the small sample has not led us to find differences and predictors of response. Probably in the future, with the Sunrise 3 trial, which has over 600 patients treated with TAR-200, we might be able to find molecular predictors of response.

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