Bladder Cancer

Avelumab plus best supportive care improved survival vs best supportive care alone in advanced urothelial carcinoma, regardless of diabetes status.

Third-line enfortumab vedotin improved outcomes in metastatic urothelial carcinoma, per real-world data from the EV-301 trial.

Enfortumab vedotin plus pembrolizumab doubled progression-free survival vs chemotherapy in urothelial cancer.

Datopotamab deruxtecan showed promising activity in advanced urothelial cancer in a phase 1 study.

UGN-102 led to durable responses in low-grade, intermediate-risk bladder cancer, per phase 3 study findings at the 2025 Genitourinary Cancers Symposium.

An FDA application for TAR-200 to treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer is under real-time oncology review, expediting access to this potential treatment.

TYRA-300 has gained an investigational new drug application from the FDA and will be further studied in the phase 2 SURF302 trial for patients with low-grade, intermediate-risk non–muscle-invasive bladder cancer.

If approved, durvalumab will be the first and only perioperative immunotherapy regimen available for the treatment of patients with muscle-invasive bladder cancer in this curative-intent setting.

In an interview, Antoni Vilaseca Cabo, MD, discussed the clinical activity of TAR-210 in patients with non-muscle invasive bladder cancer.

The FDA is currently evaluating the application of intravesical mitomycin for low-grade intermediate-risk non–muscle-invasive bladder cancer.

TYRA-300 showed promising safety and preliminary antitumor activity in FGFR3-altered metastatic urothelial cancer, with a 54.5% partial response rate and 100% disease control in the SURF301 trial.

Gilead, manufacturer of the TROP2-directed antibody-drug conjugate sacituzumab govitecan, made the decision to withdraw the agent in consultation with the FDA.

A Prescription Drug User Fee Act target action date of June 13, 2025, has been set for the new drug application of intravesical mitomycin.

The SunRISe-2 trial evaluating TAR-200 combined with cetrelimab vs chemoradiation in muscle-invasive bladder cancer has been discontinued.

Results from cohort 2 of the TROPHY-U-01 study showed that sacitizumab govitecan led to rapid responses in patients with locally advanced or metastatic urothelial carcinoma.

Panelists discuss how overall survival and event-free survival data presented at ESMO 2024 demonstrate promising outcomes in cancer treatment.

Andrea Necchi, MD, discusses how the findings from SunRISe-4 impact other data from the SunRISe group of clinical trials.

Given as neoadjuvant treatment, TAR-200 plus cetrelimab generated responses in patients with muscle-invasive bladder cancer.

In the NIAGARA trial, significant event-free survival and overall survival gains were observed with neoadjuvant durvalumab plus chemotherapy, followed by adjuvant durvalumab in cisplatin-eligible bladder cancer.

Longer follow-up from the phase 3 AMBASSADOR trial showed adjuvant pembrolizumab to demonstrate a statistically significant and clinically meaningful improvement in disease-free survival in patients with high-risk muscle-invasive urothelial carcinoma.

A new drug application has been submitted to the FDA for UGN-102, an intravesical solution for treating low-grade, intermediate-risk non–muscle-invasive bladder cancer.

Mark D. Tyson, II, MD, MPH, discussed treatment with cretostimogene grenadenorepvec in high-risk Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ and data from the BOND-003 trial.

Vikram Narayan, MD, discussed the durable clinical activity observed with nadofaragene firadenovec in the CS-003 trial for patients with non-muscle invasive bladder cancer.

Combining durvalumab with chemotherapy in the NIAGARA trial led to significant improvements in event-free survival and overall survival for patients with muscle-invasive bladder cancer.

In this feature article, key opinion leaders look at the burgeoning use of ctDNA to dictate treatment approaches for patients with bladder cancer.

Recent data, trials, approvals, and presentations during the 2024 American Urological Association Annual Meeting paint a positive treatment landscape for patients with metastatic and non–muscle-invasive bladder cancer.

Bradley McGregor, MD, discusses background of the DAD trial evaluating sacituzumab govitecan-hziy in combination with enfortumab vedotin-ejfv for the treatment of patients with treatment-resistant metastatic urothelial carcinoma.

A high complete response rate was achieved in patients with BCG–unresponsive NMIBC using the combination of cretostimogene grenadenorepvec and pembrolizumab, according to final phase 2 CORE-001 trial results.

A study found that enfortumab vedotin with pembrolizumab significantly improves survival and maintains quality-of-life compared with chemotherapy for locally advanced or metastatic urothelial cancer.

Neoadjuvant enfortumab vedotin displayed promising outcomes for cisplatin-ineligible MIBC patients, achieving a 2-year EFS rate of 62.0%. Safety was affirmed with no treatment-related delays in surgery.