Bladder Cancer

The FDA’s Oncologic Drug Advisory Committee voted 10 to 1 to continue the accelerated approval of atezolizumab for the frontline treatment of patients with urothelial cancer who are ineligible for cisplatin.

The FDA’s Oncologic Drugs Advisory Committee voted 5 to 3 in favor of continued approval of pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

During a virtual Targeted Oncology Case-Based Roundtable event, Daniel P. Petrylak, MD, discussed the case of a 66-year-old woman with metastatic bladder cancer.

Avelumab is considered a new standard-of-care treatment for patients with advanced urothelial carcinoma who have not progressed on frontline platinum-containing chemotherapy after the agent demonstrated overall survival improvement for this patient population in a phase 3 clinical trial setting.

Findings from a A phase 3 trial evaluating adjuvant nivolumab following surgery versus placebo demonstrated an improvement in median disease-free survival in patients with muscle-invasive urothelial cancer, according to results from the CheckMate 274 trial presented at the 2021 Genitourinary Cancers Symposium.

The FDA has granted priority review for 2 supplemental biologics license applications for enfortumab vedotin-ejfv for the treatment of a subset of patients with locally advanced or metastatic urothelial cancer.

It is not uncommon to have studies of nearly identical agents in nearly identical settings yield conflicting results, says Arjun V. Balar, MD.

An accelerated approval was granted by the FDA to sacituzumab govitecan for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor.

Thomas Hutson, DO, PharmD, discussed the case of a 66-year-old patient with bladder cancer during a virtual Targeted Oncology Case-Based Roundtable event.

During a virtual Targeted Oncology Case-Based Roundtable event, Anish B. Parikh, MD, discussed front-line treatment options for metastatic urothelial cancer as well as the data supporting avelumab maintenance.

Atezolizumab (is being voluntarily withdrawn from the US market by Roche for its indication as a treatment for patients with prior-platinum treated metastatic urothelial carcinoma.

The FDA has granted an Orphan Drug Designation to Padeliporfin Immune Photo Activated Cancer Therapy for the treatment of adult patients with upper tract urothelial cancer.

A promising efficacy signal was observed when the immune checkpoint inhibitor durvalumab was added concurrently to radiation followed by adjuvant durvalumab as treatment of patients with localized urothelial bladder cancer.

In an interview with Targeted Oncology, Shaakir Hasan, DO, discussed the results found when diagnostic and treatment information from patients with bladder cancer was prospectively assessed. He also discussed future work on disparities in health care in an interview with Targeted Oncology.

The durvalumab indication as a treatment for previously treated adult patients with locally advanced or metastatic bladder cancer has been voluntarily withdrawn in the United States by AstraZeneca, the developer of the PD-L1 inhibitor, the company announced in a press release.

The submission of 2 Biologic License Applications for enfortumab vedotin-ejfv have been made to the FDA for consideration as treatment of patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and who are ineligible for cisplatin.

The FDA has accepted a Biologic License Application for Vicineum as a treatment option for patients with high-risk, Bacillus Calmette-Guerin-unresponsive non–muscle invasive bladder cancer, and granted it Priority Review,.

In patients with non-muscle invasive bladder cancer carcinoma in-situ who were unresponsive to Bacillus Calmette-Guerin, the addition of N-803 induced a high rate of complete responses, findings from a cohort of the phase 2/3 QUILT-3.032 study showed.

Results from the phase 3 CheckMate-274 trial showed that nivolumab following surgery improved disease-free survival compared with placebo for patients with muscle-invasive urothelial carcinoma, according a presentation given during the 2021 ASCO Genitourinary Cancer Symposium.

Enfortumab vedotin demonstrated superior efficacy compared with chemotherapy in patients with advanced urothelial carcinoma who had previously received platinum-based chemotherapy and PD-1/L1 inhibition, according to results from a primary analysis of the phase 3 EV-301 clinical trial.

Response rates to enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors were the highest numerically observed for any regimen, according to findings from study EV-201 presented at the 2021 American Society of Clinical Oncology Genitourinary Cancer Symposium.

A subgroup analysis from the phase 3 JAVELIN Bladder 100 trial demonstrated that Japanese patients with advanced urothelial cancer whose disease did not progress on frontline chemotherapy benefited from the addition of avelumab to best supportive care in the first-line maintenance setting.

Response rates in patients with metastatic urothelial carcinoma were boosted when the novel PI3K-y inhibitor eganelisib was added to nivolumab, according to recent research presented during the American Society of Clinical Oncology 2021 Genitourinary Cancers Symposium.

Optimal therapy in the treatment of metastatic urothelial cancer has evolved over time with regulatory changes pulling back frontline indications.

An exploratory analysis of the phase 3 IMvigor130 trial demonstrated that the benefit of frontline atezolizumab added to gemcitabine and platinum chemotherapy was maintained in patients with urothelial cancer, regardless of the site of the primary tumor.

During a Targeted Oncology Case-Based Peer Perspectives Roundtable, two Mayo Clinic experts, Alan H. Bryce, MD, and Roxana S. Dronca, MD, discuss treatment options for a 66-year-old woman with urothelial carcinoma.

Eganelisib, an investigational PI3K-gamma inhibitor in combination with nivolumab, demonstrated promising efficacy compared with nivolumab alone as treatment of platinum-refractory, immunotherapy naïve patients with advanced metastatic urothelial cancer, according to updated findings from the phase 2 MARIO-275 clinical trial.

After decades of dormancy, the therapeutic landscape of locally advanced/metastatic urothelial cancer underwent a paradigm shift—with multiple regulatory approvals of immune checkpoint inhibitors as second-line treatment—leading to changes in guideline-recommended management of patients in this setting.

Neal Shore, MD, discusses the current outlook for the treatment landscape in advanced or metastatic urothelial carcinoma.

Neal D. Shore, MD, FACS, discusses the current treatment landscape and upcoming drugs being reviewed by the FDA for the treatment of patients with bladder cancer.