Urothelial Cancer

The FDA has accepted the resubmission of a biologics license application seeking the approval of N-803 in combination with Bacillus Calmette-Guérin for the treatment of patients with BCG-unresponsive, non–muscle-invasive bladder cancer with carcinoma in situ with or without Ta or T1 disease.

The intravesical chemotherapy delivery system TAR-200 provided sustained and durable responses in patients with Bacillus Calmette-Guérin–unresponsive, high-risk, non–muscle-invasive bladder cancer.

Frontline treatment with the combination of enfortumab vedotin-ejfv and pembrolizumab led to a statistically significant improvement in overall survival vs chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma.

Concurrent frontline nivolumab and gemcitabine-cisplatin followed by nivolumab maintenance therapy elicited OS and PFS benefits vs gemcitabine-cisplatin alone in patients with previously untreated, metastatic or unresectable urothelial carcinoma.

Lance C. Pagliaro, MD, discusses the efficacy of first-line avelumab maintenance therapy, as seen in the phase 3 JAVELIN Bladder 100 trial in patients with advanced urothelial carcinoma.

Marijo Bilusic, MD, PhD, discusses updates seen in the treatment armamentarium for patients with urothelial carcinoma, as presented at the 2023 Sylvester Annual Oncology Updates Meeting.

Daniel S. Childs, MD, and colleagues spotlight future innovations in the management of metastatic hormone-sensitive prostate cancer, treatment sequencing for metastatic urothelial carcinoma, and key data with PARP inhibitor combinations in metastatic castration-resistant prostate cancer.

Jue Wang, MD, discusses how to approach testing for molecular alterations in patients with relapsed or refractory urothelial carcinoma.

Jue Wang, MD, discusses the importance of personalized treatment approaches in patients with relapsed or refractory urothelial carcinoma.

Pembrolizumab as adjuvant therapy led to a statistically significant and clinically meaningful improvement in disease-free survival compared with observation in patients with localized muscle invasive urothelial cancer and locally advanced urothelial cancer.

Neil Desai, MD, discusses the potential benefits and limitations of utilizing chemoradiation or triple modality therapy for bladder preservation in the upfront management of patients with locally advanced, nonmetastatic muscle-invasive bladder cancer.

Treatment with the combination of enfortumab Vedotin and pembrolizumab led to an improvement in overall survival and progression-free survival compared with chemotherapy in previously untreated patients with locally advanced or metastatic urothelial cancer who were eligible for cisplatin- or carboplatin-containing chemotherapy.

Daniel P. Petrylak, MD, discusses the potential uses for erdafitinib, highlighting key studies evaluating the use of the agent in patients with metastatic urothelial cancer.

The Safety Monitoring Committee determined that prespecified criteria for pathologic complete response were met with the use of the PD-1 inhibitor tislelizumab alone or in combination with APL-1202 as neoadjuvant therapy in patients with muscle invasive bladder cancer.

A marketing authorization application has been submitted to the European Medicines Agency seeking the approval of erdafitinib for the treatment of adult patients with locally advanced, unresectable or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations who experienced disease progression during or following at least 1 line of therapy containing a PD-1/PD-L1 inhibitor.

Jue Wang, MD, professor, Department of Internal Medicine, member, Division of Hematology and Oncology, UT Southwestern Medical Center, discusses the benefits of switch maintenance therapy and individualized treatment strategies in patients with relapsed or refractory urothelial carcinoma.

Treatment with neoadjuvant durvalumab plus gemcitabine and cisplatin followed by radical surgery and adjuvant durvalumab for patients with muscle-invasive urothelial carcinoma resulted in 2-year event-free survival rates that met the primary end point of the phase 2 SAKK 06/17 trial.

Jue Wang, MD, highlights key takeaways regarding treatment sequencing for patients with relapsed/refractory urothelial carcinoma and the key factors that could help inform decisions for individual patients.

A supplemental new drug application seeking the full approval of erdafitinib for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations who progressed during or following at least 1 line of a PD-1/PD-L1 inhibitor in the locally advanced or metastatic setting or within 12 months of neoadjuvant or adjuvant therapy, has been submitted to the FDA.

Neil Desai, MD, MHS, expands on the need for further research regarding potential treatment strategies for patients with locally advanced, nonmetastatic muscle-invasive bladder cancer who may not benefit from standard approaches.

Daniel P. Petrylak, MD, discusses sequencing treatment selections in patients with FGFR2/3-altered metastatic urothelial cancer.

Guru P. Sonpavde, MD, discusses the importance of utilizing precision medicine in bladder cancer, and highlights the rationales and designs of the ongoing phase 3 EV-302 and AMBASSADOR trials.

Shilpa Gupta, MD, expands on the updated results from EV-103 in patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin, and details the next steps for investigating the combination of enfortumab vedotin plus pembrolizumab in the ongoing phase 3 EV-302 trial.

Petros Grivas, MD, PhD, discusses several unmet needs within urothelial cancer, as well as how to potentially ameliorate them.

Guru P. Sonpavde, MD, discusses the future of bladder cancer treatment, including potential novel targets and further research with immunotherapy and antibody-drug conjugates.