Genitourinary Cancers

Best approaches to sequencing therapy for patients with favorable-risk metastatic renal cell carcinoma following first-line therapy with novel combinations such as ipilimumab and nivolumab.

Hans Hammers, MD, PhD, discusses the efficacy of lenvatinib plus pembrolizumab in patients with advanced renal cell carcinoma.

In our exclusive interview, Dr. Choueiri and Dr. Motzer discuss the clinical implications of the phase 3 CheckMate-9ER trial in advanced renal cell carcinoma and how to best use the combination in practice.

Data from the phase 3 CheckMate-9ER trial has not only confirmed the advantage of cabozantinib plus nivolumab in terms of progression-free survival, overall survival, and responses vs sunitinib in the frontline treatment of patients with advanced renal cell carcinoma, but it has served as additional incentive to push the needle even further with research aimed at evaluating triplet regimens in the frontline setting and response-guided sequencing strategies.

The European Commission has approved the combination of cabozantinib plus nivolumab for use as a frontline treatment in patients with advanced renal cell carcinoma.

Current treatment approaches that can be used to treat favorable-risk metastatic renal cell carcinoma in the first-line setting and implications for individualizing therapy despite guidance provided by the IMDC criteria.

Bradley A. McGregor, MD, of the Dana-Farber Cancer Institute, reacts to the emergence of new treatment gaps associated with novel combination regimens as first-line therapy for patients with metastatic renal cell carcinoma.

The National Comprehensive Cancer Network has updated its Clinical Practice Guidelines to include tivozanib as a recommended regimen for subsequent therapy in patients with clear cell renal cell carcinoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion in favor of recommending that the label for pembrolizumab in Europe be updated to include findings from the phase 3 KEYNOTE-361 trial.

The European Medicines Agency has validated its type II variation application for nivolumab as an adjuvant treatment for patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.

The European Medicines Agency has accepted a marketing authorization application for enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant or adjuvant, locally advanced or metastatic setting.

The FDA has granted 2 breakthrough device designations to cover new intended uses of the Signatera molecular residual disease test developed by Natera, Inc.

Ashish M. Kamat, MD, discusses the process of meeting the needs for TICE Bacillus Calmette–Guérin in the treatment of patients with bladder cancer.

Immunotherapy is now incorporated into National Comprehensive Cancer Network guidelines as maintenance therapy and in a sequencing strategy for the treatment of patients with metastatic urothelial carcinoma and in the setting of superficial UC-carcinoma in situ with prior intravesical therapy.

Toni K. Choueiri, MD, discusses results from an exploratory analysis of the phase 3 CheckMate-9ER trial in patients with advanced renal cell carcinoma.

Robert J. Motzer, MD, discusses the efficacy of cabozantinib in patients with renal cell carcinoma.

Michael B. Atkins, MD, discusses the FDA approval of tivozanib in relapsed/refractory advanced renal cell carcinoma.

The FDA has granted priority review to the new drug application for the HIF-2α inhibitor belzutifan for the potential treatment of patients with von Hippel-Lindau–associated renal cell carcinoma that does not require immediate surgery.

Michael Devitt, MD, discusses the recent withdrawals of immunotherapy agents used to treat patients with bladder cancer.

The emergence of multiple combination regimens with immunotherapy and TKIs has been welcome for the frontline treatment of patients with metastatic renal cell carcinoma; however, without head-to-head comparative data, treatment selection has become individualized based on available patient characteristics.

Treatment options for patients with metastatic urothelial cancer have rapidly expanded as FDA approvals of immunotherapeutics push the boundaries of a once stagnant treatment landscape. Combination regimens and the addition of targeted approaches, further demonstrate progress in areas that have been tough to crack.

Six indications for immune checkpoint inhibitors granted under the FDA’s accelerated approval process that later failed confirmatory clinical trials are being reassessed as the agency continues an industry-wide evaluation of the pathway.

The FDA has approved tivozanib (Fotivda) for the treatment of adult patients with relapsed/refractory advanced renal cell carcinoma following 2 or more prior systemic therapies.

Roche has withdrawn atezolizumab from the US market for the treatment of patients with metastatic urothelial carcinoma who had previously received platinum-based therapy.

The combination of nivolumab and cabozantinib showcased significant benefit in terms of progression-free survival, overall survival, and responses vs sunitinib in the frontline treatment of patients with advanced renal cell carcinoma, as was underscored in data from the phase 3 CheckMate-9ER trial.