June Genitourinary Cancer Highlights: Top 5 Updates Patients Should Know

June brought genitourinary cancer updates, and CURE is sharing the latest in kidney cancer treatment, as well as FDA approvals, cancer vaccines and more.

As June draws to a close, it offers an opportunity to reflect on the month’s key advances in cancer care, including notable FDA approvals and notable research shared during the 2025 ASCO Annual Meeting, particularly in genitourinary (GU) cancers.

Several updates stood out across the landscape, particularly in kidney and bladder cancer, with findings that may help shape the future of patient care. These included data showing that monotherapy with Fotivda (tivozanib) may match or outperform combination therapy in previously treated metastatic renal cell carcinoma (RCC), and encouraging insights from a personalized vaccine trial in advanced kidney cancer, which showed durable immune responses. Experts also emphasized the vital role of clinical trial enrollment in RCC.

These advancements, combined with commentary from physicians and survivors throughout the month, underscore the continued momentum in cancer care that these developments bring to patients and families, as well as providers.

Monotherapy Treatment Had Efficacy in Previously Treated Metastatic RCC

In a subgroup analysis of the TiNivo-2 phase 3 trial, researchers explored Fotivda treatment, either alone or combined with Opdivo (nivolumab), for patients with metastatic RCC whose disease had worsened after initial treatment with immune checkpoint inhibitors (ICI). Findings suggested that Fotivda by itself offered comparable or even better outcomes in terms of progression-free survival and objective response rates when compared to the combination therapy.

Dr. Alexander Chehrazi-Raffle from City of Hope sat down in an interview with CURE to discuss these results, emphasizing that the study helps clarify whether Fotivda as a monotherapy or in combination is the better second-line treatment for mRCC patients who have already undergone immunotherapy.

"Yeah, I think the subgroup analysis reiterates what we found in the phase 3 trial: the combination of immunotherapy plus VEGF is not superior to VEGF alone after patients have already progressed on an immunotherapy regimen," he said.

Chehrazi-Raffle is an assistant professor in the Department of Medical Oncology & Therapeutics Research, at City of Hope, located in Duarte, California.

What Patients With GU Cancers Need to Know After ASCO 2025

The 2025 ASCO Annual Meeting provided a wealth of knowledge in oncology, particularly for GU cancers like prostate and bladder cancer, offering updates that could redefine patient care. To dissect these significant advancements, Dr. Joshua K. Sabari and Dr. Daniel V. Araujo engaged in a discussion, sharing their insights on practice-changing developments from the meeting. Their conversation aimed to illuminate how these new standards and treatment updates will influence future clinical practice for genitourinary cancer patients.

"ASCO, as you know, is always a great meeting to attend, where numerous abstracts are presented, and data is consolidated. This year, particularly in genitourinary cancers, we saw some interesting developments," Araujo explained.

Sabari is the editor in chief of CURE, as well as an assistant professor in the Department of Medicine at NYU Grossman School of Medicine and director of High Reliability Organization Initiatives at Perlmutter Cancer Center. Araujo serves as a medical oncologist at the University of Florida Health (UF) Health.

Why is Clinical Trial Enrollment Important for Those With Kidney Cancer?

During an interview with CURE, Dr. Michael Serzan highlighted the importance of clinical trial enrollment for patients with RCC and discussed recent findings from the phase 1b STELLAR-002 study, presented at the 2025 ASCO Annual Meeting. This study investigated zanzalintinib, a new VEGF TKI with a shorter half-life than similar drugs like Cabometyx (cabozantinib), in combination with Opdivo, and in a triplet arm adding Opdualag (relatlimab-rmbw), for patients with metastatic kidney cancer.

“If you are eligible for a clinical trial, it's important to discuss the potential benefits of enrolling… We are firm believers that it's the only way we advance the science of the field. Many times, patients receive even better care while on clinical trials because we are actively trying to move the field forward and using tomorrow's treatments today,” Serzan, a medical oncologist in the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and an instructor of medicine at Harvard Medical School, located in Boston, said in the interview.

Dr. Serzan emphasized that while the bar for new kidney cancer treatments is high due to many existing effective therapies, a future phase 2 study would be needed to further assess efficacy and potentially compare these combinations against current standards of care.

FDA Approves UGN-102 For Some With Bladder Cancer

On June 12, the U.S. Food and Drug Administration approved UGN-102 (mitomycin intravesical solution) for adult patients suffering from recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). This approval was based on data from the phase 3 ENVISION trial, which enrolled 240 patients whose low-grade NMIBC had returned after previous surgical removal of bladder tumors (TURBT).

Of the 223 patients whose responses could be evaluated, an impressive 78% achieved a complete response, meaning no cancer remained in their bladder as confirmed by internal visual examination, urine tests, and, if necessary, biopsy. Furthermore, among those who responded to the treatment, 79% remained cancer-free for at least one year. Patients eligible for the study had specific characteristics, including multiple tumors, a single tumor larger than 3 cm, or a cancer recurrence within one year.

Personalized Vaccine Elicits Responses in Patients With Kidney Cancer

Dr. David Braun, an assistant professor at Yale School of Medicine and a member of Yale Cancer Center, served as the principal investigator and first author of a significant trial published in Nature. This research delved into the potential of vaccines for patients with cancer. In this study, all nine patients with advanced kidney cancer who received a personalized vaccine developed successful anticancer immune responses and remained cancer-free for approximately three years.

Dr. Braun emphasized that while kidney cancer vaccines are still in the experimental phase and not yet regulatory-approved, the initial findings are encouraging and have led to larger clinical trials. The concept behind these therapeutic vaccines is to ‘steer’ the immune system precisely towards tumor cells by identifying their unique ‘fingerprint,’ a crucial difference from current, less precise immunotherapies. This personalized approach aims to address the high risk of recurrence in patients with high-risk kidney cancer.

“Kidney cancer vaccines really are still at the experimental phase, meaning they’re still in clinical trials. There’s no vaccine that’s standardly available for kidney cancer that’s approved by any regulatory agency, so they’re still under investigation, and they’re in their early stages. I always want to caution that these are initial studies that have come out, but I would say the initial data is promising,” Braun said.

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