Urothelial Cancer

China’s National Medical Products Administration has approved enfortumab vedotin for adult patients with locally advanced or metastatic urothelial cancer.

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

The Nectin-4–directed antibody-drug conjugate 9MW2821 has received breakthrough therapy designation in China for pretreated, advanced urothelial carcinoma.

Enfortumab vedotin plus pembrolizumab improved survival vs chemotherapy with no QOL detriment in previously untreated metastatic urothelial cancer.

Drs Park and Grivas discuss bladder cancer treatment updates, including results from the SunRISe-1 trial of TAR-200 plus cetrelimab in NMIBC.

Roger Li, MD, discusses the efficacy of bladder-sparing therapy after progression on pembrolizumab in patients with BCG-unresponsive, high-risk NMIBC.

First-line avelumab maintenance demonstrated efficacy and manageable toxicity in patients with low tumor burden advanced urothelial carcinoma.

The CHMP has recommended pembrolizumab plus enfortumab vedotin-ejfv in frontline unresectable or metastatic urothelial carcinoma.

Drs Park and Sonpavde discuss findings from the phase 1 DAD trial, as well as a schema for the frontline management of metastatic urothelial carcinoma. 

Antonio Cigliola, MD, discusses the phase 2 SURE-01 study of neoadjuvant sacituzumab govitecan in muscle-invasive bladder cancer.

IDE937 produced responses in patients with advanced urothelial cancer or non–small cell lung cancer harboring MTAP deletions.

Rohan Garje, MD, discusses the benefits of a multimodal approach for patients with small cell bladder cancer.

Brian I. Rini, MD, FASCO, on findings from a biomarker analysis of the KEYNOTE-426 trial of pembrolizumab/axitinib vs sunitinib in renal cell carcinoma.

Antonio Cigliola, MD, discusses the evaluation of neoadjuvant sacituzumab govitecan in patients with muscle-invasive bladder cancer.

Laurence Albigès, MD, PhD, discusses the potential predictive and prognostic value of circulating KIM-1 in patients with renal cell carcinoma.

Tazemetostat plus pembrolizumab was tolerable in platinum-exposed or -ineligible advanced urothelial carcinoma.

The EMA's CHMP has adopted a positive opinion regarding erdafitinib in patients with FGFR3+ unresectable or metastatic urothelial carcinoma.

Antonio Cigliola, MD, discusses interim efficacy data from the SURE-01 study investigating neoadjuvant sacituzumab govitecan in patients with MIBC.

Bradley McGregor, MD, on the ongoing evaluation of sacituzumab govitecan plus enfortumab vedotin with or without pembrolizumab in urothelial carcinoma.

Perioperative durvalumab demonstrated a statistically significant improvement in EFS and OS in muscle-invasive bladder cancer.

David Braun, MD, PhD, discusses findings from the molecular analysis of the HCRN GU16-260-Cohort A study.

Fernando C. Maluf, MD, PhD discusses the efficacy of platinum-based chemotherapy plus pembrolizumab in advanced penile squamous cell carcinoma.

Michael Serzan, MD, discusses the use of botensilimab/balstilimab in the treatment of patients with advanced renal cell carcinoma.

Roger Li, MD, discusses patient outcomes from the KEYNOTE-057 trial in BCG–unresponsive, high-risk non–muscle-invasive bladder cancer.

Joaquim Bellmunt, MD, PhD discusses findings from a post-hoc analysis for avelumab maintenance in advanced urothelial carcinoma with low tumor burden.