Dr Necchi on Final Data From SunRISe-2 in Muscle-Invasive Bladder Cancer

“Overall, the study did not meet the primary end point of improving BI-EFS. In both arms, the estimates with chemoradiotherapy and experimental therapy at 1 year were particularly promising and higher than expected.”

Andrea Necchi, MD, associate professor of oncology at Vita-Salute San Raffaele University and director of Genitourinary Medical Oncology at IRCCS San Raffaele Hospital, discussed the data from the final analysis of the phase 3 SunRISe-2 study (NCT04658862), which were presented during the 2026 Genitourinary Cancers Symposium.

SunRISE-2 evaluated the gemcitabine intravesical system (Gem-iDRS; Inlexzo; previously TAR-200) in combination with cetrelimab (JNJ-63723283) for the treatment of patients with muscle-invasive bladder cancer (MIBC) not receiving radical cystectomy. The primary end point was bladder-intact event-free survival (BI-EFS); secondary end points included 18-week overall response rate, metastasis-free survival, overall survival, and safety.

Findings from the final analysis revealed that the median BI-EFS among patients who received Gem-iDRS plus cetrelimab (n = 262) was not reached (NR; 95% CI, 22.93-not evaluable [NE]) compared with NR (95% CI, 26.58-NE) in patients treated with concurrent chemoradiotherapy (n = 256). The 6-month BI-EFS rates were 73.5% (95% CI, 66.6%-79.3%) and 86.9% (95% CI, 80.9%-91.2%), respectively; the 12-month BI-EFS rates were 65.5% (95% CI, 57.9%-72.1%) and 79.9% (95% CI, 72.3%-85.6%), respectively.

Necchi noted that these data did not meet the primary end point of the study. However, the 12-month BI-EFS rates in both arms were higher than expected and particularly promising, he added. Patients in the chemoradiotherapy arm specifically outperformed the expected results when the trial was initially conceived. Due to the promising complete rates and other signals of activity, Gem-iDRS plus cetrelimab should be further investigated in this patient population, he concluded.

Disclosures: Necchi reported being employed by Bayer, holding stock and other ownership interests in Bayer; holding a consulting or advisory role with AstraZeneca, Bicycle Therapeutics, Bristol-Myers Squibb, Catalym, Genenta Science, Gilead Sciences, Incyte, Johnson & Johnson/Janssen, Merck Serono, Merck Sharp & Dohme, Peerview, PeerVoice, Samsung Bioepis, and Seattle Genetics/Astellas; receiving research funding from Bristol-Myers Squibb/Celgene (Inst), Gilead Sciences (Inst), and Merck Sharp & Dohme (Inst); and receiving travel, accommodations, and/or expenses from AstraZeneca, Gilead Sciences, Janssen, and Merck Sharp & Dohme.