Dr. Daneshmand highlights positive TAR-200 data in BCG-unresponsive NMIBC
Siamak Daneshmand, MD, discusses initial findings from the phase 2b SUNRISE-1 trial exploring the novel intravesical chemotherapy delivery system TAR-200 in non–muscle-invasive bladder cancer.
Siamak Daneshmand, MD, discusses initial findings from the phase 2b SUNRISE-1 trial, which he presented at the 2023 AUA Annual Meeting. The results showed that the novel intravesical chemotherapy delivery system TAR-200 elicited complete responses (CRs) in nearly three-fourths of patients with BCG-unresponsive, high-risk non–muscle-invasive bladder cancer (NMIBC).
TAR-200 works by providing continuous low-doses of localized gemcitabine via insertion into the bladder. The SUNRISE-1 data shared at AUA showed that TAR-200 achieved a CR rate of 72.7% (95% CI, 49.8-89.3), consisting of 16 CRs in 22 evaluable patients.
Further, at a median follow-up of 10.6 months, 15 of the 16 CRs remained ongoing and the median duration of response was not reached. Of the complete responders, 6 maintained their response for more than 12 months, and none of the complete responders had disease recurrence or progression.
SUNRISE-1 is also assessing the PD-1 inhibitor cetrelimab in this setting, and the initial data showed that the CR rate with single-agent cetrelimab was 38.1% (95% CI, 18.1-61.6), consisting of 8 CRs among 21 evaluable patients.
Overall, patients in SUNRISE-1 are being randomized to 3 treatment arms: cohort 1 is TAR-200 dosed every 3 weeks for up to 24 weeks, then every 12 weeks until week 96 (year 2) plus cetrelimab dosed every 3 weeks through week 78; cohort 2 is TAR-200 alone at the same dose as cohort 1; and cohort 3 is cetrelimab alone dosed at the same dose as cohort 1.
Daneshmand is a professor of Urology, director of Clinical Research, Keck Medicine of USC.
Advancing bladder cancer care: The importance of integrating mental health support
September 9th 2024"I think the fact that we're having these conversations, that they are being talked about at national meetings, and that we are bringing the patient voice into this is hugely important," says Mary W. Dunn, MSN, NP-C, OCN, RN.
Speaking of Urology Podcast: Dr. Ritch and Dr. Katz discuss new bladder cancer management app
December 7th 2021“It's not a replacement for clinical judgment, obviously. But at the end of the day, the idea is that it shows you what your next steps are based on what the American Urological Association and [Society of Urologic Oncology] guidelines are for non-muscle invasive bladder cancer,” Chad R. Ritch, MD, MBA, FACS.
