publication date: Apr. 26, 2019
Drugs & Targets
FDA approves pembrolizumab plus axitinib for advanced RCC
FDA approved pembrolizumab plus axitinib (Keytruda) for the first-line treatment of patients with advanced renal cell carcinoma.
Keytruda is sponsored by Merck.
Approval was based on KEYNOTE‑426 (NCT02853331), a randomized, multicenter, open-label trial conducted in 861 patients who had not received systemic therapy for advanced RCC. Patients were enrolled regardless of PD-L1 tumor expression status and were randomly allocated to receive either pembrolizumab 200 mg intravenously every 3 weeks in combination with axitinib 5 mg orally twice daily, or sunitinib 50 mg orally once daily for 4 weeks and then off treatment for 2 weeks.
Treatment was continued until confirmed disease progression or unacceptable toxicity. Pembrolizumab was received for a maximum of 24 months.
The main efficacy measures were overall survival and progression-free survival, assessed by blinded independent central review (RECIST 1.1.) The trial demonstrated a statistically significant improvement in OS in a pre-specified interim analysis for patients on the pembrolizumab plus axitinib arm (HR 0.53; 95% CI: 0.38, 0.74; p<0.0001).
With deaths reported in 18% of patients, the median OS was not reached in either arm. The 12-month OS rate was 90% in the pembrolizumab plus axitinib arm and 78% for those treated with sunitinib. The trial also demonstrated a PFS improvement for patients receiving pembrolizumab plus axitinib (HR 0.69; 95% CI: 0.57, 0.84; p=0.0001). Median PFS was 15.1 and 11.1 months for those receiving pembrolizumab plus axitinib vs. sunitinib, respectively.
The recommended pembrolizumab dose for this indication is 200 mg every 3 weeks with axitinib 5 mg orally twice daily.
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