ASCO 2023: Head-to-Head Effectiveness and Safety of Pembrolizumab plus Axitinib vs. Nivolumab plus Ipilimumab in Metastatic Renal Cell Carcinoma in the United States

(UroToday.com) The 2023 American Society of Clinical Oncology (ASCO) annual meeting held in Chicago, IL between June 2nd and June 6th was host to a kidney and bladder cancers poster session. Dr. Dvir Aran presented the results of an analysis comparing the effectiveness and safety of pembrolizumab plus axitinib versus nivolumab plus ipilimumab in metastatic renal cell carcinoma (RCC) in the United States.


There are numerous combination regimens currently approved for the 1st line treatment of metastatic RCC patients. However, head-to-head comparisons within the context of clinical trials are absent, and real-world data comparing their efficacy and safety in clinical practice are limited. In this study, the authors sought to perform a real-world analysis within the context of the US health care system comparing the overall survival and post-treatment hospitalization rates of metastatic RCC patients receiving combination pembrolizumab + axitinib (PD-1 inhibitor/VEGF-targeted therapy) versus ipilimumab + nivolumab (CTLA-4 inhibitor/PD-1 inhibitor).

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The investigators utilized the Elevance Health administrative claims and clinical data from the AIM Cancer Quality Program to identify metastatic RCC patients treated with either pembrolizumab + axitinib or ipilimumab + nivolumab between June 2018 and March 2022. The authors utilized inverse probability of treatment weighting (IPTW) to adjust for age, sex, socioeconomic deprivation index, Eastern Cooperative Oncology Group (ECOG) performance status, Charlson Comorbidity Index, and metastatic sites. Overall survival was defined as the time from first treatment until date of death or last claim. Survival analysis with a weighted Kaplan Meier curve was performed, with between group comparisons performed using the log-rank test.

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This analysis included a total of 764 patients, of whom 281 and 483 received pembrolizumab + axitinib and ipilimumab + nivolumab, respectively. Consistent with the IPTW propensity score technique, baseline characteristics were well-balanced between the two groups.

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Overall, no significant differences were observed in overall survival between the two treatment groups (p=0.07). At 12 months, the overall survival was 86% for patients receiving pembrolizumab + axitinib versus 78% for nivolumab + ipilimumab (p<0.001). At 24 months, this survival advantage was no longer significant with overall survival rates of 68% and 65%, respectively (p=0.52).

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Three-months post-treatment hospitalization rates were significantly higher in the ipilimumab + nivolumab group (32% versus 20%, p<0.001).

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The investigators concluded that real-world analysis from the United States suggests that pembrolizumab + axitinib may be associated with short-term overall survival benefits with lower three months post-treatment hospitalization rates. They hypothesized that the increased toxicity of combination ipilimumab + nivolumab may limit this combination’s short-term efficacy, leading to the worse short-term survival outcomes.

Presented by: Dvir Aran, PhD, BSc, MSc, Faculty of Biology, Technion-Israel Institute of Technology

Written by: Rashid Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, IL, Fri, June 2 – Tues, June 6, 2023.