Risk Stratification of Patients with Advanced Renal Cell Carcinoma

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EP: 1.Risk Stratification of Patients with Advanced Renal Cell Carcinoma

EP: 2.Comparing Approved First-Line IO-TKI and IO-IO Combination Treatment Regimens in Advanced Clear Cell RCC

EP: 3.Case Presentation: A Patient with Favorable Risk Advanced Clear Cell RCC

EP: 4.Selecting a Treatment Regimen for Favorable Risk Advanced Clear Cell RCC

EP: 5.Single-Agent TKI Therapy in Favorable Risk Advanced Clear Cell RCC

EP: 6.Frontline Therapy in Advanced Clear Cell RCC: The CLEAR Trial

EP: 7.Rationale for Lenvatinib plus Pembrolizumab Therapy in Frontline Setting in Advanced Clear Cell RCC

EP: 8.Dosing Strategies for Lenvatinib in Advanced Clear Cell RCC

EP: 9.IO-TKI Combination Therapies: Are They Synergistic or Additive?

EP: 10.Managing Adverse Effects During a Lenvatinib plus Pembrolizumab Combination Therapy Regimen

EP: 11.Treatment Regimens for Patients with Advanced Clear Cell RCC and Bone or Liver Metastasis

EP: 12.Advanced Clear Cell RCC with Intermediate-Risk and the CHECKMATE-214 Trial

EP: 13.Advanced Clear Cell RCC and the KEYNOTE 426 Trial

EP: 14.Advanced Clear Cell RCC and the CHECKMATE 9ER Trial

EP: 15.Tolerability of IO/TKI Combination Therapy for Advanced Clear Cell RCC

EP: 16.Tolerability of IO/TKI versus IO/IO Combination Treatments in Advanced Clear Cell RCC

EP: 17.Selecting an Appropriate Combination Therapy for Patients with Advanced Clear Cell RCC

EP: 18.Switching Therapies in Advanced Clear Cell RCC without Dose Reduction

EP: 19.Adjuvant Therapy in Clear Cell RCC

EP: 20.Clear Cell RCC and the KEYNOTE 564 Trial

EP: 21.Design, Criteria, and Endpoints of KEYNOTE 564

EP: 22.Adjuvant Therapy Treatment Approaches for Patients with Advanced Clear Cell RCC

EP: 23.DFS vs OS Primary Endpoints in KEYNOTE 564

Nizar Tannir, MD: Hello, and welcome to our Targeted Oncology™ Virtual Tumor Board, which is focused on advances in frontline therapy of advanced clear cell renal cell carcinoma. I’m Nizar Tannir. I’m a professor in the department of genitourinary medical oncology at The University of Texas MD Anderson Cancer Center. I’m joined by my esteemed colleagues Dr Scott Tykodi, an associate professor of oncology at the University of Washington and Fred Hutchinson Cancer Center; and Dr Moshe Ornstein, a genitourinary medical oncologist at the Cleveland Clinic Taussig Cancer Institute.

In this presentation, my colleagues and I will review clinical cases, discuss approaches to treating patients with advanced renal cell carcinoma, and share our perspectives on key clinical trial data that may impact our treatment decisions. Let’s get started.

You’re all familiar with the IMDC [International Metastatic Renal Cell Carcinoma Database Consortium] risk categorization. There are 4 laboratory factors and 2 clinical factors that independently influence survival of patients with advanced renal cell carcinoma. There are 6 risk factors. The 2 clinical risk factors are: less than 1 year from time of diagnosis to systemic therapy, and a Karnofsky Performance Score of less than 80%. The 4 laboratory factors are anemia, neutrophilia, elevated corrected serum calcium level, and thrombocytosis. Fit patients with favorable risk won’t have any of these risk factors. Patients with intermediate risk will have 1 or 2 of these risk factors.

Patients with poor risk will have 3 or more. The median survival for patients with favorable risk, intermediate risk, and poor risk is 43.2 months, 22.5 months, and 7.8 months, respectively. I’d like to note that these survival data are from the era of targeted therapies. This is now in flux. It’s changing, as we now have immune checkpoint therapy in the first-line therapy of these patients.

These are the NCCN [National Comprehensive Cancer Network] Guidelines. You’re all familiar with NCCN Guidelines. We refer to them. This is a summary of therapies in the first-line setting for advanced clear cell renal cell carcinoma. I’d like to point out that our focus on this program is on the most common type of renal cell carcinoma: clear cell or conventional type renal cell carcinoma.

I’d like to draw our attention to the first column, which is the preferred regimens for favorable risk as we have defined them by IMDC. The 3 regimens that have received category 1 by the NCCN are axitinib plus pembrolizumab, cabozantinib plus nivolumab, and lenvatinib plus pembrolizumab. For patients with poor and intermediate risk, the 5 therapies that have been selected as preferred regimens for patients with advanced renal cell carcinoma are axitinib plus pembrolizumab, cabozantinib plus nivolumab, ipilimumab plus nivolumab, lenvatinib plus pembrolizumab, and cabozantinib. Note that 4 of these have received category 1 based on high-level evidence based on randomized phase 3 trials. Cabozantinib was based on a randomized phase 2 trial, CABOSUN.

Transcript edited for clarity.