Advanced Renal Cell Carcinoma: Nivolumab/Cabozantinib Approved

The FDA has approved nivolumab (Opdivo®, Bristol Myers Squibb) in combination with cabozantinib (Cabometyx®, Exelixis) for patients with advanced renal cell carcinoma (RCC) receiving their first line of therapy. "As monotherapies, nivolumab and cabozantinib have demonstrated efficacy and a manageable safety profile in advanced RCC," wrote Toni Choueiri, MD, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, and colleagues in their abstract of results from the...
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Renal Cell Carcinoma: Subtype, Site of Metastasis Impacts Survival

There are over a dozen histologic variants of renal cell carcinoma (RCC); therefore, each tumor can vary widely based on genetic, pathologic, and clinical characteristics. The most common histologic variants of RCC include clear cell RCC, papillary RCC, and chromophobe RCC. In a recent study, results of which are now published in JAMA Network Open, researchers found that disease spread for metastatic RCC may vary based on histologic variant, and the location of disease spread is associated with ...
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FDA Issues Draft Guidances for Bladder Cancer, Renal Cell Carcinoma

The FDA has issued draft guidance documents for drug and biologic development in the adjuvant treatment of renal cell carcinoma (RCC) and bladder cancer, with recommendations for clinical trials concerning eligibility criteria, methodology, and use of disease-free survival as an end point. "The FDA has actively encouraged a more uniform approach to developing clinical trials to evaluate adjuvant treatments for renal cell carcinoma and bladder cancer, including hosting a public workshop in p...
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Nivolumab/Ipilimumab for Advanced Renal Cell Carcinoma: Meredith Regan, ScD

Patients with advanced renal cell carcinoma (RCC) who receive combination PD-1/CTLA-4 blockade can experience periods of durable benefit and toxicity after treatment discontinuation. According to results of the phase 3 CheckMate 214 trial presented by Meredith Regan, ScD, at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, nivolumab/ipilimumab prolongs treatment-free survival, both with and without toxicity, in patients with previously untreated advanced clear cell RCC. In...
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Advanced Renal Cell Carcinoma: Nivolumab/Ipilimumab Improves Treatment-Free Survival

Nivolumab/ipilimumab prolongs treatment-free survival with and without toxicity in patients with untreated advanced renal cell carcinoma (RCC), according to an updated analysis of the phase 3 CheckMate 214 trial presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. "Conventional measures may not fully characterize the impact of immuno-oncology agents," comment the investigators in their presentation abstract, led by first author Meredith Regan, ScD, Associate Profe...
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