Advancing Bladder Cancer Care Through Education and Awareness

From the debut of non-platinum perioperative regimens in muscle-invasive disease to the first FDA approval of an immune checkpoint inhibitor combined with BCG in the non-muscle-invasive setting, the bladder cancer treatment landscape is evolving at a pace that experts describe as transformative.

In honor of Bladder Cancer Awareness Month, which is celebrated annually in May, OncLive® spoke with the following experts to get their perspectives on the present and future of the bladder cancer treatment paradigm and to discuss unmet needs in the space:

• Ashish M. Kamat, MD, MBBS, FACS, an endowed professor and the Wayne B. Duddlesten Sr. Professorship in Cancer Research in the Department of Urology, Division of Surgery, at The University of Texas MD Anderson Cancer Center in Houston.
• Matthew Galsky, MD, the director of Genitourinary Medical Oncology, co-director of the Center of Excellence for Bladder Cancer, the deputy director, and a professor of medicine (Hematology and Medical Oncology) at the Mount Sinai Tisch Cancer Center in New York, New York.
• Timothy N. Clinton, MD, associate surgeon at Brigham and Women’s Hospital, as well as a surgical oncologist at Dana-Farber Cancer Institute, both in Boston, Massachusetts. 
• Stephanie A. Berg, DO, medical oncologist for the Lank Center of Genitourinary Oncology at Dana-Farber Cancer Institute and an instructor in medicine at Harvard Medical School in Boston, Massachusetts.

“[Since] May is Bladder Cancer Awareness Month, every year we reach out to our community to raise awareness around [the disease],” Kamat said. “We were fortunate to [hold] an event prior to the 2026 American Urological Association [AUA] Annual Meeting where we announced the results of the Global Bladder Burden Survey. Raising awareness amongst patients and physicians of the mental health impact that the diagnosis and treatment of bladder cancer has on patients, carers, and even physicians is very important as we look to the future.”

What were the key findings from the 2026 Global Bladder Burden Survey?

The Global Bladder Burden Survey was conducted by The Harris Poll on behalf of Johnson & Johnson in collaboration with the International Bladder Cancer Group (IBCG), the World Bladder Cancer Patient Coalition, and the Bladder Cancer Advocacy Network (BCAN).^1,2 The survey collected data from 817 patients with non–muscle-invasive bladder cancer (NMIBC) and 802 urologists from the United States, Mexico, Brazil, Japan, Germany, and France. It was conducted from November 25, 2025, to December 29, 2025; each country was combined with a post weight to give them an equal proportion of the total.

Findings from the survey revealed that approximately 90% of patients who underwent radical cystectomy or received BCG reported negative effects on their physical, emotional, and mental health; more than 50% of these effects were labeled as moderate or significant. Nearly all the respondents (95%) reported missing important life moments due to treatment, and over 50% of respondents indicated that they hide their feelings about the emotional impact of bladder cancer from their urologist.

“[We want to] raise awareness [around] bladder cancer from the perspective of how we can alleviate not only the disease end points but [also] the psychological, financial, economic, and social toxicity,” Kamat, who is also the founding president of the IBCG, commented.

Further data from the survey revealed that 45% of patients reported experiencing depression and anxiety as a primary driver of missed or avoided life moments. Approximately 33% of patients cited limiting life disruption as a top priority when making treatment decisions, with 47% of urologists agreeing with this priority.

Notably, patients and urologists were aligned in a shared interest in progress in the treatment of bladder cancer, with approximately 90% of urologists indicating that they wished there were better ways to address the emotional and mental effects of the disease. A strong majority of patients and urologists indicated a desire for more innovative treatment approaches beyond those that are currently in use.

How have targeted therapies and novel agents shifted the treatment landscape of MIBC?

During the 2026 Genitourinary Cancers Symposium (ASCO GU), investigators presented data from the phase 3 KEYNOTE-905/EV-303 (NCT03924895) and KEYNOTE-B15/EV-304 trial (NCT04700124) studies, which marked a “new era” in the treatment of muscle-invasive bladder cancer (MIBC) with non–platinum-containing systemic regimens, Galsky said. KEYNOTE-905 evaluated perioperative enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) in cisplatin-ineligible MIBC while KEYNOTE-B15 examined the approach in cisplatin-eligible MIBC.^3,4

In KEYNOTE-B15, the median event-free survival (EFS) was not reached (NR; 95% CI, NR-NR) in patients who were treated with enfortumab vedotin plus pembrolizumab (n = 405) compared with 48.5 months (95% CI, 43.3-NR) among patients who received cisplatin plus gemcitabine (n = 403; HR, 0.53; 95% CI, 0.41-0.70; 1-sided P < .0001).³ The 24-month EFS rates were 79.4% and 66.2%, respectively; the respective 12-month EFS rates were 86.0% and 75.4%.

Data from KEYNOTE-905 demonstrated that the median disease-free survival (DFS) was NR (95% CI, NR-NR) in patients who received enfortumab vedotin plus pembrolizumab (n = 135) vs 23.6 months (95% CI, 13.7-NR) with pembrolizumab alone (n = 129; HR, 0.37; 95% CI, 0.23-0.59).⁴ The respective pathologic complete response (pCR) rates were 57.1% and 8.6%, representing an estimated difference of 48.3% (95% CI, 39.5%-56.5%; 1-sided P < .000001).

“Both studies showed higher pCR rates, higher EFS and higher overall survival, marking a new era in the treatment of MIBC with a non–platinum-containing systemic therapy regimen,” Galsky commented.

In November 2025, the FDA approved enfortumab vedotin in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) as neoadjuvant treatment followed by adjuvant treatment after cystectomy in cisplatin-ineligible patients with MIBC. The approval was supported by data from KEYNOTE-905.⁵

In April 2026, data from KEYNOTE-B15 supported the FDA’s decision to grant priority review to 2 supplemental biologics license applications seeking the approval of pembrolizumab or pembrolizumab and berahyaluronidase alfa, each in combination with enfortumab vedotin, for the perioperative treatment of patients with MIBC who are eligible for cisplatin-based chemotherapy.⁶ The Prescription Drug User Fee Act target action date is August 17, 2026.

More recently, expanded efficacy and safety analyses of the phase 3 POTOMAC trial (NCT03528694) demonstrated that the addition of durvalumab (Imfinzi), another immune checkpoint inhibitor, to BCG induction and maintenance therapy significantly reduced the risk of high-risk disease recurrence or death vs BCG induction and maintenance alone in patients with BCG-naive, high-risk NMIBC.⁷ Results presented during the 2026 American Urological Association (AUA) Annual Meeting showed that the study met its primary end point of DFS, demonstrating a HR of 0.68 (95% CI, 0.50-0.93; P = .0154) in favor of the investigational arm at a median follow-up of 60.7 months. Additionally, the DFS HR among patients with papillary-only tumors also favored the durvalumab arm (HR, 0.56; 95% CI, 0.37-0.84; P = .0046).

In May 2026, the FDA approved durvalumab in combination with BCG for the treatment of adult patients with BCG-naive, high-risk NMIBC.⁸ The approval was supported by data from POTOMAC.

“The introduction of antibody-drug conjugates plus immune checkpoint blockade combination regimens has really transformed the way we treat bladder cancer, both in the metastatic setting and now in the muscle-invasive setting. There are still unmet needs related to not only increasing the likelihood of eradicating bladder cancer but also doing so while optimally maintaining patients' quality of life and survivorship. Multiple ongoing efforts are aimed at achieving those goals,” Galsky noted.

Beyond checkpoint inhibition, intravesical gene therapies such as detalimogene voraplasmid have shown promise in NMIBC and could fill an unmet need for patients who are ineligible for or relapsed/refractory to standard agents. During the 2026 AUA Annual Meeting, investigators presented interim data from the pivotal phase 2 LEGEND trial (NCT04752722) which evaluated detalimogene voraplasmid in patients with BCG-unresponsive NMIBC with carcinoma in situ.⁹

At a median follow-up of 5.5 months (range, 1.0-25.8 months), evaluable patients (n = 125) experienced a complete response (CR) rate at any time of 54.0% (95% CI, 44.9%-63.0%) with detalimogene voraplasmid. The median time to onset of CR was 2.1 months (range, 1.5-6.2 months), and the estimated 12-month CR rate was 25% (95% CI, 11%-41%).

“In this interim analysis, [detalimogene voraplasmid] was safe and very well tolerated. The durability data [are] encouraging, but it's important to remember that they are preliminary. It's also encouraging to note that 96.8% of patients were free of progression to muscle-invasive or greater disease,” Kamat noted during the presentation.

How do gender differences affect bladder cancer diagnosis and management?

Although the emergence of targeted therapies and other recent clinical advances have greatly bolstered the bladder cancer treatment armamentarium, a major remaining underserved area in the space is the diagnosis and management of the disease in female patients, Timothy N. Clinton, MD, and Stephanie A. Berg, DO, argued.

“This is an underrecognized topic, and I’m glad we’re shedding some light on it. [During] ASCO GU, there was an entire panel on gender differences within bladder cancer.¹⁰ I believe there’s a lot more coming to light in [terms of] bladder cancer and gender differences,” Clinton said.

Berg and Clinton noted that bladder cancer can often be underdiagnosed in female patients because some of the most common symptoms of the disease, such as hematuria and urinary frequency or urgency, can be initially treated as a urinary tract infection (UTI). “The psychological burden is real. Women can experience significant anxiety and depression in this context. Coming into the primary care office month after month with UTI symptoms, getting antibiotics each time, and not having an explanation, that accumulates. I agree that part of our job is empowering patients to advocate for themselves while also working with primary care to lower the threshold for referral,” Berg explained.

“Awareness is the number 1 priority,” Clinton said. “Whether it’s through BCAN or other foundations and support groups, getting the message out is critical. This increases the likelihood that primary care providers and internists will recognize the risk factors, signs, and symptoms more closely linked with bladder cancer in women.”

References

1. Groundbreaking global survey captures the significant patient burden experienced with current standard-of-care bladder cancer treatments, underscoring urgency for continued innovation. News release. Johnson & Johnson. May 14, 2026. Accessed May 29, 2026. https://www.investor.jnj.com/investor-news/news-details/2026/Groundbreaking-global-survey-captures-the-significant-patient-burden-experienced-with-current-standard-of-care-bladder-cancer-treatments-underscoring-urgency-for-continued-innovation/default.aspx
2. Beyond the diagnosis: what living with bladder cancer really looks like. News release. Johnson & Johnson. May 14, 2026. Accessed May 29, 2026. https://www.jnj.com/oncology/bladderburdensurvey
3. Galsky MD, Valderrama BP, Maruzzo M, et al. Neoadjuvant and adjuvant enfortumab vedotin (EV) plus pembrolizumab (pembro) for participants with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin: randomized, open-label, phase 3 KEYNOTE-B15 study. J Clin Oncol. 2026;44(suppl 7):LBA630. doi: 10.1200/JCO.2026.44.7_suppl.LBA630
4. Ullén A, Vulsteke C, Bedke J, et al. Pathological outcomes and disease-free survival (DFS) in KEYNOTE-905: neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible. J Clin Oncol. 2026;44(suppl 7):638. doi:10.1200/JCO.2026.44.7_suppl.638
5. FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer. FDA. November 21, 2025. Accessed May 29, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer
6. FDA grants priority review for Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each with Padcev (enfortumab vedotin-ejfv), for cisplatin-eligible patients with muscle-invasive bladder cancer. News release. Merck. April 20, 2026. Accessed May 29, 2026. https://www.merck.com/news/fda-grants-priority-review-for-keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-with-padcev-enfortumab-vedotin-ejfv-for-cisplati/
7. Shore ND, De Santis M, Palou Redorta J, et al. Durvalumab in combination with BCG induction and maintenance therapy for BCG-naive, high-risk non–muscle-invasive bladder cancer: expanded efficacy and safety analyses from POTOMAC. J Urol. 2026;215(5S2):e3. doi:10.1097/01.JU.0001192572.07890.f8.05
8. FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer. FDA. May 28, 2026. Accessed May 29, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-bacillus-calmette-guerin-high-risk-non-muscle-invasive-bladder
9. Kamat AM, Tyson M, Rendon R, et al. A non-viral intravesical gene therapy for BCG-unresponsive NMIBC with CIS, with or without papillary disease: pivotal phase 2 interim results of detalimogene voraplasmid. J Urol. 2026;215(5S2):e2. doi:10.1097/01.JU.0001192572.07890.f8.04
10. Ingersoll M. Biological differences underlying sex and gender disparities in bladder cancer. Presented at: 2026 Genitourinary Cancers Symposium; February 26-28, 2026; San Francisco, CA.