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HEALTH PROFESSIONAL · SOURCE READING

Pembrolizumab plus axitinib

Source: Renal Cell Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.

Source updated: May 13, 2025 · Captured 2026-09-09.

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Context: Treatment of Stage IV and Recurrent Renal Cell Cancer / Combined Immune Checkpoint Inhibitors and Antiangiogenic Targeted Therapies

Evidence (pembrolizumab plus axitinib):

An open-label, phase III, randomized controlled trial (NCT02853331) compared sunitinib with the combination of pembrolizumab and axitinib. The study enrolled 861 patients who had received no previous systemic therapy for metastatic disease.[2]

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An open-label, phase III, randomized controlled trial (NCT02853331) compared sunitinib with the combination of pembrolizumab and axitinib. The study enrolled 861 patients who had received no previous systemic therapy for metastatic disease.[2]

With median follow-up of 12.8 months, the 1-year OS rate was 90% in the pembrolizumab-plus-axitinib arm, compared with 78% in the sunitinib arm (HR, 0.53; 95% CI, 0.38–0.74; P < .0001).[2][Level of evidence A1]

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An open-label, phase III, randomized controlled trial (NCT02853331) compared sunitinib with the combination of pembrolizumab and axitinib. The study enrolled 861 patients who had received no previous systemic therapy for metastatic disease.[2]

Median PFS was also prolonged for patients who received the combination therapy (15.1 months vs. 11.1 months; HR, 0.69; 95% CI, 0.57–0.84).

An open-label, phase III, randomized controlled trial (NCT02853331) compared sunitinib with the combination of pembrolizumab and axitinib. The study enrolled 861 patients who had received no previous systemic therapy for metastatic disease.[2]

The objective response rate was 59.3% for patients who received combination therapy, compared with 35.7% for patients who received sunitinib (P < .001).

An open-label, phase III, randomized controlled trial (NCT02853331) compared sunitinib with the combination of pembrolizumab and axitinib. The study enrolled 861 patients who had received no previous systemic therapy for metastatic disease.[2]

Grade 3 or higher adverse event rates were similar: 75.8% of the patients in the pembrolizumab-plus-axitinib arm, compared with 70.6% of the patients in the sunitinib arm.

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Preserved source evidence · Not medical advice