Oncology Experts Highlight the Key Data and Top Abstracts From AUA 2025

Colin P.N. Dinney, MD

Following the 2025 American Urological Association (AUA) Annual Meeting, OncLive® asked oncology experts to highlight some of the top data and key abstracts they saw presented over the course of the conference.

In our exclusive recap, hear insights from the following experts on the top findings from AUA 2025:

• Joseph Jacob, MD, MCR, an associate professor of urology at Upstate University Hospital in Syracuse, New York
• Alireza Ghoreifi, MD, a Society of Urologic Oncology fellow at Duke University in Durham, North Carolina
• Felix Guerrero-Ramos, MD, PhD, an attending urologist at Hospital Universitario 12 de Octubre in Madrid, Spain
• Colin P.N. Dinney, MD, chairman and W.A. "Tex" & D. Moncrief, Jr. Distinguished Chair in Urology of the Department of Urology in the Division of Surgery, and co-chair of the Genitourinary Steering Committee - Bladder Task Force, at The University of Texas MD Anderson Cancer Center

“In the plenary session [on Saturday], there was some exciting work [presented] on non–muscle-invasive bladder cancer [NMIBC],” Dinney said. “[Data on] a lot of new agents in NMIBC were reported on [during the meeting].”

Guerrero-Ramos’ Top Highlights

Felix Guerrero-Ramos, MD, PhD

Sasanlimab in combination with Bacillus Calmette-Guérin improves event-free survival versus Bacillus Calmette-Guérin as standard of care in high-risk non–muscle-invasive bladder cancer: phase 3 CREST study results1

“For me, one of the most important abstracts presented has been the [phase 3] CREST trial [NCT04165317]. This is the first time in 50 years that we have a therapy that beats BCG alone. We have seen that the combination of sasanlimab with classical BCG induction plus maintenance over 2 years has beat classical BCG induction and maintenance. Along with the event-free survival [EFS] data, duration of response [DOR] data were very relevant for those [patients with] CIS.

Findings from the phase 3 study showed that the addition of sasanlimab to BGC reduced the risk of an EFS event by 32% vs BCG alone (stratified HR, 0.68; 95% CI, 0.49-0.94; 1-sided P = .0095). The 24-month EFS rates were 84.7% for sasanlimab plus BCG induction and maintenance therapy (n = 352) vs 79.9% with BCG induction and maintenance therapy alone (n = 351); the respective 36-month rates were 82.1% and 74.8%.

TAR-200 monotherapy in patients with Bacillus Calmette-Guerin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-12

TAR-200 monotherapy in patients with bacillus Calmette-Guerin–unresponsive papillary disease–only high-risk non–muscle-invasive bladder cancer: first results from Cohort 4 of SunRISe-13

“Being focused on bladder cancer, because this is the pathology I treat every day, I am excited with all the data from cohort 4 of SunRISe-1, but we also have the data from cohort 2 of SunRISe-1, [which showed] an impressive complete response [CR] rate for [patients with NMIBC with] carcinoma in situ [CIS] and a very significant duration of response [DOR], which is good for our patients.”

Data from cohort 4 showed that patients with high-risk, BCG-unresponsive NMIBC with papillary only disease (n = 52) achieved a median disease-free survival that was not reached (95% CI, 12.1-not estimable) at a median follow-up of 12.8 months. Notably, only 5.8% of patients underwent cystectomy during the study.

In cohort 2 of SunRISe-1, patients with high-risk, BCG-unresponsive NMIBC with CIS with or without papillary disease (n = 82) experienced a CR rate of 82.4% (95% CI, 72.6%-89.8%) when treated with TAR-200 monotherapy. The 12-month CR rate was 45.9%.

Treatment of recurrent non-muscle invasive bladder cancer with UGN-301 (zalifrelimab): Results of a phase 1 dose-escalation study4

BOND-003 cohort C: a phase-3, single-arm study of intravesical cretostimogene grenadenorepvec for high-risk BCG-unresponsive NMIBC with CIS5

“I also liked the data from the [phase 1] trial [NCT05375903] evaluating UGN-301. [Cretostimogene grenadenorepvec] also had impressive data on those BCG-unresponsive patients with NMIBC with CIS [in the phase 3 BOND-003 trial (NCT04452591)].

In the phase 1 study of UGN-301 in patients with recurrent NMIBC (n = 20), data showed that the agent was well tolerated. Regarding efficacy, 46% of patients with Ta/T1 disease (n = 13) achieved a CR at week 12 or were free from recurrence free. This rate was 33% among patients with CIS with or without Ta/T1 disease (n = 6).

In BOND-003, cretostimogene grenadenorepvec generated a CR rate of 75.5% (95% CI, 66.3%-83.2% in patients with high-risk, BCG-unresponsive NMIBC with CIS. The 12-month CR rate was 46.4% (95% CI, 36.9%-56.1%), and the 12-month Kaplan-Meier–estimated CR rate was 50.7% (95% CI, 40.9%-59.8%). The 24-month CR rate was 33.7% (95% CI, 24.8%-43.8%).

Jacobs’ Top Highlights

Joseph Jacob, MD, MCR

“I’m partial to the plenary session. It would be worth watching the recordings or looking at the abstracts. There are a lot of new data coming out [in NMIBC].

Sasanlimab in combination with Bacillus Calmette-Guérin improves event-free survival versus Bacillus Calmette-Guérin as standard of care in high-risk non–muscle-invasive bladder cancer: phase 3 CREST study results

BOND-003 cohort C: a phase-3, single-arm study of intravesical cretostimogene grenadenorepvec for high-risk BCG-unresponsive NMIBC with CIS

“We did not know the [full] data for the CREST trial prior to [AUA]. The BOND-003 trial was presented as well. Bladder cancer is probably the most exciting disease state right now, but I’m biased.”

Ghoreifi’s Top Highlights

Alireza Ghoreifi, MD

Consolidative Surgery for Advanced Urothelial Carcinoma Following Induction Enfortumab Vedotin and/or Immune Checkpoint Inhibitor Therapy: A Multicenter Analysis6

Perioperative outcomes of consolidative surgery following immunotherapy with pembrolizumab plus enfortumab vedotin for advanced urothelial cancer7

“There were data from the Mayo Clinic, [which] showed outcomes of consolidative surgery following [enfortumab vedotin-ejfv (Padcev) and/or checkpoint inhibitor–containing regimens] in [advanced urothelial cancer]. Interestingly, even though the cohort [from Mayo Clinic] might be somehow different from [our study] in terms of demographics or geographical area, the pathologic CR [pCR] rate was similar to ours. This gives us more confidence to talk about the conclusion of our study [regarding] the pCR rate, the [tumor] down staging, and the nodal response. When you have multiple studies showing the same results, it gives us more confidence about the validity of our study.”

Findings from the Mayo Clinic study showed that 52.2% of patients treated with enfortumab vedotin and/or a checkpoint inhibitor–containing regimen (n = 23) experienced a radiographic CR during induction therapy. The rates of pT downstaging and pN downstaging were 82.6% and 76.9%, respectively.

References

1. Shore ND, Powles T, Bedke J, et al. Sasanlimab in combination with Bacillus Calmette-Guérin improves event-free survival versus Bacillus Calmette-Guérin as standard of care in high-risk non–muscle-invasive bladder cancer: Phase 3 CREST study results. Presented at: 2025 American Urological Association Annual Meeting; April 26-29, 2025; Las Vegas, NV.
2. Maruzzo M, Padron O, Ribal MJ, et al. Treatment of recurrent non-muscle invasive bladder cancer with UGN-301 (zalifrelimab): Results of a phase 1 dose-escalation study. Presented at: American Urological Association Annual Congress; April 26-29, 2025; Las Vegas, NV. IP02-34.
3. Guerrero-Ramos F, Jacob JM, Van der Heijden MS, et al. TAR-200 monotherapy in patients with bacillus Calmette-Guerin–unresponsive papillary disease–only high-risk non–muscle-invasive bladder cancer: first results from Cohort 4 of SunRISe-1. Presented at: 2025 American Urological Association Annual Meeting; April 26-29, 2025; Las Vegas, NV.
4. Jacob JM, Guerrero-Ramos F, Necchi A, et al. TAR-200 monotherapy in patients with Bacillus Calmette-Guerin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1. Presented at: American Urological Association Annual Congress; April 26-29, 2025; Las Vegas, NV. P2s.
5. Tyson M. BOND-003 cohort C- a phase-3, single-arm study of intravesical cretostimogene grenadenorepvec for high-risk BCG-unresponsive NMIBC with CIS. Presented at: American Urological Association Annual Congress; April 26-29, 2025; Las Vegas, NV.
6. Roberson D, Nguyen M, Reitano G, et al. Consolidative Surgery for Advanced Urothelial Carcinoma Following Induction Enfortumab Vedotin and/or Immune Checkpoint Inhibitor Therapy: A Multicenter Analysis. Presented at: American Urological Association Annual Congress; April 26-29, 2025; Las Vegas, NV. Abstract PD37-07.
7. Ghoreifi A, Hoimes C, Ramalingham S, et al. Perioperative outcomes of consolidative surgery following immunotherapy with pembrolizumab plus enfortumab vedotin for advanced urothelial cancer. Presented at: 2025 American Urological Association Annual Meeting. April 26-29, 2025. Las Vegas, NV. Abstract MP05-20.