UGN-101 shows promise in low-grade upper tract urothelial cancer
In this open-label, single-arm, phase 3 trial, patients with primary or recurrent low-grade upper tract urothelial cancer (measuring 5–15 mm in maximum diameter) received 6 once-weekly instillations UGN-101 via retrograde catheter to the renal pelvis and calyces.
Of the 71 patients who received at least 1 dose of UGN-101, 42 had a complete response at the primary disease evaluation visit 4 to 6 weeks after the completion of initial therapy. The median follow-up for patients with a complete response was 11 months
All-cause adverse events included ureteric stenosis in 44% of patients, urinary tract infection in 32%, haematuria in 31%, flank pain in 30%, and nausea in 24%.
Study drug-related or procedure-related serious adverse events were reported in 27% of patients. No deaths were regarded as related to treatment
The authors concluded that UGN-101 has the potential to offer a kidney-sparing treatment alternative for patients with low-grade upper tract urothelial cancer
Kleinmann N, Matin SF, Pierorazio PM, et al. Primary chemoablation of low-grade upper tract urothelial carcinoma using UGN-101, a mitomycin-containing reverse thermal gel (OLYMPUS): an open-label, single-arm, phase 3 trial. Lancet Oncology. 2020; DOI:https://doi.org/10.1016/S1470-2045(20)30147-9