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FDA Approves Pembrolizumab Plus Axitinib in Advanced Kidney Cancer

By: Sarah Jackson
Posted: Monday, April 22, 2019

On April 19, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma.

Approval was based on KEYNOTE‑426 (ClinicalTrials.gov identifier NCT02853331), a randomized, multicenter, open-label trial conducted in 861 patients who had not received systemic therapy for advanced renal cell carcinoma. Patients were enrolled regardless of PD-L1 tumor expression status and were randomly allocated to receive either pembrolizumab intravenously every 3 weeks in combination with axitinib orally twice daily, or sunitinib orally once daily for 4 weeks and then off treatment for 2 weeks. Treatment continued until confirmed disease progression or unacceptable toxicity. Pembrolizumab was received for a maximum of 24 months.

The trial demonstrated a statistically significant improvement in overall survival in a prespecified interim analysis for patients in the pembrolizumab-plus-axitinib arm. With deaths reported in 18% of patients, the median overall survival was not reached in either arm. The 12-month overall survival rate was 90% with pembrolizumab plus axitinib and 78% with sunitinib. The trial also demonstrated a progression-free survival improvement for patients receiving pembrolizumab plus axitinib. The median progression-free survival was 15.1 and 11.1 months for those receiving pembrolizumab plus axitinib vs. sunitinib, respectively. 

The most common adverse reactions in more than 20% of patients who received pembrolizumab plus axitinib were diarrhea, fatigue/asthenia, hypertension, hypothyroidism, decreased appetite, hepatotoxicity, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation. 

The recommended pembrolizumab dose for this indication is 200 mg every 3 weeks with axitinib at 5 mg orally twice daily.



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