Urothelial Cancer

See this full list of regulatory decisions from 2024 regarding withdrawn agents, label updates, and new drug formulations.

Experts highlight the top presentations to watch for at the 2025 Genitourinary Cancers Symposium.

Vikram M. Narayan, MD, details updates in the bladder cancer field, including effects of the BCG shortage and upcoming therapies/tools of interest.

The EMA has accepted for review an MAA seeking the approval of nogapendekin alfa inbakicept plus BCG for BCG-unresponsive NMIBC with CIS.

Durable responses with UGN-102 signal its viability as a nonsurgical alternative to TURBT in low-grade, intermediate-risk NMIBC.

Rohan Garje, MD, discusses the unmet needs for patients with small cell bladder cancer.

John K. Lee, MD, PhD, discusses the EV-302 trial of frontline enfortumab vedotin plus pembrolizumab in locally advanced or metastatic urothelial cancer.

An NDA has been submitted to the FDA seeking the approval of TAR-200 for BCG-unresponsive high-risk NMIBC with CIS, with or without papillary tumors.

First-line nivolumab plus chemotherapy numerically improved survival vs chemotherapy alone in Asian patients with unresectable/metastatic urothelial cancer.

Neal Shore, MD, FACS, discusses implications of data for sasanlimab plus BCG in BCG-naive, high-risk non–muscle-invasive bladder cancer.

Sasanlimab plus BCG improved event-free survival in BCG-naive, high-risk non–muscle-invasive bladder cancer.

Yair Lotan, MD, discusses the benefits and complications associated with radical cystectomy for patients with BCG-unresponsive NMIBC.

Yair Lotan, MD, discusses the evolving treatment paradigm for Bacillus Calmette-Guérin–unresponsive non–muscle-invasive bladder cancer.

Durvalumab plus vaccine therapy demonstrated evidence of preliminary antitumor activity without substantial additive toxicity in BCG-unresponsive NMIBC.

Enfortumab vedotin-efjv plus has received NMPA approval for patients with locally advanced or metastatic urothelial cancer.

Tremelimumab plus paclitaxel induced responses in metastatic urothelial cancer after progression on platinum and an immune checkpoint inhibitor.

Benjamin Garmezy, MD, discusses the rationale for developing zelenectide pevedotin in metastatic urothelial carcinoma.

The phase 3 TROPiCS-04 study missed its primary end point of improved OS with sacituzumab govitecan vs chemotherapy in patients with urothelial cancer.

Thomas Powles, MBBS, MRCP, MD, discusses how according to the ESMO guidelines, enfortumab vedotin plus pembrolizumab (EV+P) has become the new standard of first-line therapy in advanced urothelial carcinoma, and if there are patients who are ineligible for EV+P, alternatives are available such as nivolumab plus cisplatin/gemcitabine or platinum-based chemotherapy followed by maintenance avelumab.

Thomas Powles, MBBS, MRCP, MD, discusses how antibody-drug conjugates have demonstrated improvement over chemotherapy. Data from the EV-301 trial shows that the antibody-drug conjugate enfortumab vedotin decreased the risk of death by 30% versus chemotherapy. Later trial data showed that treatment using enfortumab vedotin plus pembrolizumab (EV+P) reduced the risk of patient death by 53%.

Guru P. Sonpavde, MD, discusses the AMBASSADOR trial of pembrolizumab in muscle-invasive and locally advanced urothelial carcinoma.

Thomas Powles, MBBS, MRCP, MD, discusses how avelumab maintenance in bladder cancer has been challenging. Specifically in sequenced immune therapy, there was a 25% decrease in patient deaths, but only 50% of the patients survived. Powles also introduces the anatomy of an antibody-drug conjugate (ADC).

Thomas Powles, MBBS, MRCP, MD, discusses how the KEYNOTE-361 trial failed because of the trial’s design. Data show that the maintenance phase of the trial is what was driving the benefit and that the longest survival with this trial was 17 months with both pembrolizumab and chemotherapy treatment rather than just chemotherapy.

Guru P. Sonpavde, MD, discusses the implications of treatment with the NIAGARA trial regimen in cisplatin-eligible muscle-invasive bladder cancer.

Janaki Neela Sharma, MD, discusses how data from EV-302 further defined the role of frontline enfortumab vedotin plus pembrolizumab in bladder cancer.