The OncLive Genitourinary Cancer condition center page is a comprehensive resource for clinical news and expert insights across genitourinary (GU) malignancies, including renal cell carcinoma, urothelial carcinoma, and prostate cancer. This section features news articles, interviews in written and video format, and podcasts that focus on the evolving treatment paradigm of GU cancers and emerging research.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of single-agent pembrolizumab for use as an adjuvant treatment in adult patients with renal cell carcinoma who are at increased risk of recurrence after nephrectomy, or following nephrectomy and the resection of metastatic lesions.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion in favor of the approval of enfortumab vedotin as a monotherapy in the treatment of adult patients with locally advanced or metastatic urothelial cancer.
Pembrolizumab demonstrated a statistically significant and clinically meaningful improvement in disease-free survival vs placebo as a postnephrectomy adjuvant therapy in patients with renal cell carcinoma at intermediate-high or high risk of recurrence, and in those who are M1 with no evidence of disease.
The combination of pembrolizumab and axitinib demonstrated comparable activity and safety vs sunitinib in Japanese patients vs the global population of patients with newly diagnosed metastatic renal cell carcinoma enrolled in the phase 3 KEYNOTE-426 trial.
Manojkumar Bupathi, MD, MS, shares the main highlights from the meeting, which centered on frontline, second, and later-line treatment of metastatic urothelial carcinoma and metastatic renal cell carcinoma.
The FDA has approved pembrolizumab for the adjuvant treatment of patients with renal cell carcinoma who are at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
For patients with advanced clear cell renal cell carcinoma, it will be of utmost importance to recognize the variation in response and type of progression with first-line therapy, the patient’s characteristics and motivations, and the promise of new agents and combinations.
Treatment selection and sequencing in genitourinary cancers, such as metastatic bladder cancer and metastatic renal cell carcinoma, have become more complicated and require nuanced decision making.
The FDA has greenlit an investigation new drug application to expand the ongoing phase 1/2 ABILITY trial, which is evaluating the beta-only IL-2 superagonist MDNA11 in patients with solid tumors, to clinical trial sites in the United States.