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ASCO 2021: 42-Month Follow-up of Pembrolizumab Plus Axitinib in Advanced Clear Cell Kidney Cancer

By: Vanessa A. Carter, BS
Posted: Tuesday, June 8, 2021

At the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, Brian I. Rini, MD, of the Vanderbilt-Ingram Cancer Center, Nashville, and colleagues presented the 42-month follow-up date of the phase III KEYNOTE-426 trial, which explored the efficacy of pembrolizumab plus axitinib versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma (Abstract 4500). The investigators concluded that the combination therapy demonstrated “superior efficacy over sunitinib with respect to overall survival, progression-free survival, and objective response rate, with no new safety signals.”

The investigators enrolled 861 patients with treatment-naive advanced clear cell renal cell carcinoma. Participants were randomly assigned 1:1 to receive up to 35 doses of pembrolizumab at 200 mg plus 5 mg of axitinib (n = 432) or 50 mg of sunitinib monotherapy (n = 429). Treatment was continued until patient withdrawal, intolerable toxicity, or disease progression.

At the time of data cutoff, 193 patients given pembrolizumab plus axitinib and 225 patients given sunitinib had died, yielding a median overall survival of 45.7 months for the combination group and 40.1 months for the monotherapy group (P < .001); the two groups had progression-free survivals of 15.7 and 11.1 months (P < .0001), respectively. For patients treated with pembrolizumab plus axitinib, the objective response rate was 60.4%, the complete response rate was 10.0%, and the median duration of response was 23.6 months. Alternatively, those treated with sunitinib had corresponding rates of 39.6%, 3.5%, and 15.3 months, respectively.

About 47.2% of patients on the combination therapy received subsequent treatment, versus 65.6% of individuals on sunitinib. Despite VEGF/VEGFR inhibitors being administered to a comparable number of patients in each arm, 10.2% of patients given pembrolizumab plus axitinib were treated with a PD-1/L1 inhibitor, compared with 48.7% of patients given monotherapy.

Disclosure: For full disclosures of the study authors, visit coi.asco.org.



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