UroGen Pharma says ATLAS results show ‘robust’ UGN-102 durability

UroGen Pharma announced results from a new analysis of the ATLAS trial, which estimates using Kaplan Meier methods the probabilities of remaining in complete response for both new and recurrent low-grade intermediate-risk non- muscle invasive bladder cancer patients following treatment with investigational drug UGN-102 as primary therapy, with or without subsequent transurethral resection of the bladder tumor at three months. In the Phase 3 ATLAS study, 282 patients with new or recurrent LG-IR-NMIBC were randomized to primary treatment with UGN-102 +/- TURBT or TURBT alone. In the overall study population, disease free survival and durability of response Rates favored primary treatment with UGN-102 +/- TURBT compared to TURBT alone. Complete response rates at the 3-month disease assessment were similar in both arms. While DFS and DOR rates were previously shared for both arms of the study, these are the first data specifically looking at the rates among new and recurrent patients within the UGN-102 +/- TURBT arm, the company said. In this analysis using Kaplan Meier methods, DOR at 12 months after achieving CR at 3 months was 87.5% and 69.1% in new and recurrent patients, respectively. Also, patients achieved similar probabilities of DFS rates for UGN-102 at 15 months from randomization.