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.

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.

A retrospective cohort of patients with metastatic urothelial cancer who received prior enfortumab vedotin had low efficacy when treated with sacituzumab govitecan, with the best outcomes coming from direct sequencing the two agents.

Results from the AURA trial show the survival benefits of cisplatin-based chemotherapy in combination with avelumab.

Vikram Narayan, MD, discusses the significance of the 5-year overall survival and cystectomy-free survival rates of nadofaragene firadenovec-vncg in treating patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer.

RAG-01 has received an FDA fast track designation and is being investigated for the treatment of non-muscle invasive bladder cancer.

Antoni Vilaseca Cabo, MD, discusses phase 1 data presented on TAR-210 for the treatment of patients with FGFR-altered high- and intermediate-risk non-muscle invasive bladder cancer.

In an interview with Targeted Oncology, Shilpa Gupta, MD, discussed the rationale and potential significance of the MAIN-CAV trial in patients with locally advanced/metastatic urothelial carcinoma.

Sima Porten, MD, MPH, discusses the rationale for the phase 3 SunRISe-5 study of TAR-200 in non-muscle invasive bladder cancer and unmet needs in this patient population.

Non-muscle invasive bladder cancer treatment with TAR-210 demonstrated safety and clinical activity in FGFR-altered high- and intermediate-risk patient groups.

In patients at 15 centers who had upper tract urothelial cancer, those with no evidence of disease after UGN-101 induction had a 68% rate of 3-year recurrence-free survival, and this outcome did not differ based on tumor status, method of instillation, or treatment intent.

Nadofaragene firadenovec maintained its durable clinical activity at 5 years in patients with high-risk, BCG-unresponsive non–muscle-invasive bladder cancer.

Maintenance UGN-101 therapy demonstrated good durability of response in initial responders with low-grade upper tract urothelial cancer, as evidenced by a low rate of disease progression in a multicenter, longitudinal follow-up study.

Combination therapy with nivolumab and gemcitabine-cisplatin showed promising results in treating metastatic urothelial carcinoma with significantly improved overall survival and progression-free survival rates.