Urothelial Cancer

The FDA has accepted for review a biologics license application for the IL-15 superagonist N-803 for the treatment of patients with Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer carcinoma in situ.

Enfortumab vedotin-ejfv plus pembrolizumab induced encouraging responses when used in the frontline treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-based chemotherapy.

The clinical development of Vicineum for use as a potential therapeutic option in patients with high-risk, Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.

Neil Desai, MD, discusses the variety of options available for patients with localized urothelial cancer who are ineligible for cisplatin-based chemoradiation.

Benjamin Garmezy, MD, discussed the positive trajectory of antibody-drug conjugates and immunotherapy in urothelial carcinoma, highlighting the importance of considering individual patient eligibility for treatments like first-line chemotherapy.

Pedro C. Barata, MD, MSc, discusses challenges associated with treating advanced urothelial carcinoma.

The FDA has granted a fast track designation to belzupacap sarotalocan for the treatment of patients with non–muscle invasive bladder cancer, representing the first virus-like drug conjugate candidate therapy from Aura Biosciences, Inc., the drug developer.

The addition of tislelizumab to nab-paclitaxel demonstrated efficacy and safety in patients with high-risk non–muscle invasive bladder cancer.

Enfortumab vedotin extended overall survival by 3.97 months compared with chemotherapy for patients with locally advanced or metastatic urothelial carcinoma.

Disitamab vedotin demonstrated promising efficacy with a tolerable safety profile in patients with HER2-negative metastatic urothelial carcinoma.

Shilpa Gupta, MD, discusses the results of the PARADIGM study in locally advanced or metastatic urothelial cancer.

Tian Zhang, MD, discusses the benefits of multidisciplinary collaboration, how to select the best agents for each patient, and how treatments such as radiation in RCC and bladder-sparing chemoradiation in urothelial cancer fit into the overall treatment paradigms for these diseases.

Shilpa Gupta, MD, discusses the methodologies utilized in the PARADIGM study in locally advanced or metastatic urothelial cancer.

Shilpa Gupta, MD, discusses the design of the PARADIGM study in locally advanced or metastatic urothelial cancer.

Vignesh Packiam, MD, discusses the adverse effects associated with cabazitaxel and gemcitabine with pembrolizumab in patients who are unresponsive to docetaxel with non-muscle invasive urothelial carcinoma.

The addition of maintenance avelumab to best supportive care demonstrated improved outcomes for patients with advanced urothelial carcinoma including those who went on to receive second-line therapy.

Tumor mutational burden served as a prognostic indicator of the efficacy of toripalimab among Chinese patients with urothelial carcinoma.

Cabozantinib plus atezolizumab demonstrated promising clinical activity and a suitable safety profile as first-line therapy in patients with cisplatin- eligible and -ineligible, inoperable locally advanced or metastatic urothelial cancer and as second- or later-line therapy in those who received a prior immune checkpoint inhibitor, according to findings from the phase 1b COSMIC-021 trial.

Results of the ATLANTIS study do not support further investigation of cabozantinib alone as a maintenance therapy after platinum-based chemotherapy in unselected patients with advanced urothelial cancer.

Matthew Galsky, MD, discusses the design and findings of the phase 3 CheckMate 274 trial in urothelial cancer.

Neoadjuvant administration of the antibody drug conjugate enfortumab vedotin-ejfv represents a potential future treatment option for patients with muscle invasive bladder cancer who are ineligible for cisplatin-based chemotherapy.

Vignesh Packiam, MD, discusses the investigation of cabazitaxel and gemcitabine with pembrolizumab in patients who are unresponsive to docetaxel with non-muscle invasive urothelial carcinoma.

Matthew Galsky, MD, discusses the rationale of the phase 3 CheckMate 274 trial in urothelial cancer.

A biologics license application seeking the approval of N-803 in combination with Bacillus Calmette-Guérin in patients with BCG-unresponsive, non–muscle invasive bladder cancer carcinoma in situ with or without Ta or T1 disease has been submitted to the FDA.

Sacituzumab govitecan will be further evaluated in patients with locally advanced unresectable or metastatic urothelial cancer that has progressed after prior platinum or checkpoint inhibitor therapy, as a part of the phase 3 TROPiCS-04 trial.