According to the results of subgroup analyses of patients with advanced clear cell renal cell carcinoma (RCC) enrolled in a phase 3 clinical trial evaluating the combination of the programmed cell death-1 (PD-1) inhibitor, pembrolizumab, plus axitinib, a selective vascular epithelial growth factor receptor (VEGF)-1,-2, and -3 receptor tyrosine kinase inhibitor, versus single-agent sunitinib, the efficacy benefits of the former regimen previously observed for the overall study population were also seen in the subgroup of patients with intermediate- or poor-risk disease. The findings of this study were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.

In the open-label, phase 3 KEYNOTE-426 trial (ClinicalTrials.gov Identifier: NCT02853331), the primary end points of progression-free survival (PFS) and overall survival (OS) were significantly longer, and the secondary end point of overall response rate (ORR) was significantly higher, for the overall population of patients with advanced clear cell carcinoma randomly assigned (1:1) to receive pembrolizumab plus axitinib (200 mg IV every 3 weeks plus axitinib 5 mg orally twice daily) compared with those in the sunitinib arm (50 mg orally once daily for 4 weeks every 6 weeks).

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Furthermore, these results, in conjunction with the corresponding safety data showing manageable toxicity for the combination of pembrolizumab plus axitininib, led to its recent approval by the US Food and Drug Administration (FDA) for the treatment of patients with advanced RCC in the first-line setting.3

This analysis of data from the KEYNOTE-426 study focused on determining outcomes in specific subgroups of patients with favorable or intermediate- or high-risk features as assessed by the International Metastatic RCC Database Consortium (IMDC) risk groups, as well as in those with disease specifically characterized by sarcomatoid features. Another study objective was to determine the thresholds of percentage of tumor shrinkage from baseline in these subgroups. 

In the overall study population with measurable disease, 94% versus 85% of patients treated with immunotherapy-based treatment compared with sunitinib had some decrease in the size of target lesions. The respective rates for those with tumor shrinkage by 60% or higher (42% versus 16%), 80% or higher (17% versus 6%), and 100% (ie, complete response [CR]; 9% versus 3%) favored patients receiving pembrolizumab plus axitinib.  

This article originally appeared on Cancer Therapy Advisor