IKCS 2022: Real-world Clinical Outcomes of Patients with Metastatic Renal Cell Carcinoma Receiving Pembrolizumab + Axitinib vs Ipilimumab + Nivolumab

(UroToday.com) The 2022 IKCS North American annual meeting featured a presentation by Dr. Neil Shah discussing real-world clinical outcomes of patients with metastatic renal cell carcinoma (RCC) receiving pembrolizumab + axitinib versus ipilimumab + nivolumab. IO based therapies have changed the treatment paradigm in the first-line metastatic RCC in the last few years with robust clinical trial data. Dr. Shah and colleagues performed a comparison of real-world data for pembrolizumab + axitinib with ipilimumab + nivolumab for clinical outcomes among metastatic RCC patients in a community oncology setting.


This retrospective cohort study used structured and chart review data from iKnowMed, a US community Oncology electronic health record database, to identify adult clear cell metastatic RCC patients initiating first-line pembrolizumab + axitinib or ipilimumab + nivolumab from April 1, 2019 to December 31, 2020 who were followed through March 31, 2021. Treatment pattern and physician-recorded response (real-world overall response rate and real-world disease control rate) were assessed descriptively. Real-world time on treatment, real-world time to next treatment, overall survival (OS) and progression-free survival (PFS) were estimated using Kaplan-Meier method. Definitions of clinical outcomes are as follows:

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The study included 331 eligible patients (pembrolizumab + axitinib 44% [n = 145], ipilimumab + nivolumab 56% [n=186]). The median age was 65 years (range, 59-73), 76% (n=250) were male, and 82% (pembrolizumab + axitinib 76%, ipilimumab + nivolumab 88%) had intermediate/poor IMDC risk score. Additionally, the median follow-up was 10.1 (range, 5.8 - 14.7) for pembrolizumab + axitinib and 10.7 (range, 5.2 - 15.4) months for ipilimumab + nivolumab. Overall, 25% (n = 83) and 11% (n = 35) patients received second-line and third-line treatments, respectively. Cabozantinib (52%) was the most common second-line treatment. The real-world overall response rate and real-world disease control rate were 71%, 80% and 45%, 59% for pembrolizumab + axitinib and ipilimumab + nivolumab, respectively. The 12-month OS rate was 82.5% for pembrolizumab + axitinib and 71.1% for ipilimumab + nivolumab. The 12-month real-world time to next treatment, real-world time on treatment and real-world PFS rate was 61.9%, 47.2%, and 55.0% for pembrolizumab + axitinib and 47.0%, 26.3% and 44.9% for ipilimumab + nivolumab, respectively. As follows is the Kaplan-Meier curves for PFS in the overall study cohort and intermediate/poor IMDC risk score:

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As follows is the Kaplan Meier curves for real-world time on treatment in the overall study cohort and intermediate/poor IMDC risk score:

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Finally, as follows is the Kaplan Meier curves for real-world time to next treatment in the overall study cohort and intermediate/poor IMDC risk score:

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Dr. Shah concluded his presentation discussing real-world clinical outcomes of patients with metastatic RCC receiving pembrolizumab + axitinib versus ipilimumab + nivolumab with the following concluding statements:

  • This real-world study of treatment exposure (real-world time to next treatment, real-world time on treatment, and PFS) of IO based metastatic RCC treatments in the US community oncology setting provides insights into their effectiveness, tolerability, and/or compliance
  • Pembrolizumab + axitinib was associated with longer PFS, real-world time to next treatment, and real-world time on treatment, and great objective response rate and disease control rate in overall and IMDC intermediate/poor risk groups
  • Longer follow-up is needed to better characterize OS

Presented by: Neil J. Shah, MD, Memorial Sloan Kettering Cancer Center, New York, NY

Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, @zklaassen_md on Twitter during the 2022 International Kidney Cancer Symposium (IKCS) North America, November 4-5, Austin, Texas, USA