FDA Approves Keytruda plus Inlyta as First-Line Treatment for Advanced RCC

On April 19, 2019, the FDA accelerated the approval of pembro­lizumab (Keytruda; Merck) plus axitinib (Inlyta; Pfizer) for the first-line treatment of patients with advanced renal-cell carcinoma (RCC). Keytruda has received previous FDA approval as a single agent or in combination with other agents for the treatment of many types of cancers.

This latest approval was based on the phase 3, randomized, open-label, phase 3 KEYNOTE-426 clinical trial of 861 patients with clear-cell metastatic RCC who had not received systemic therapy for metastatic disease. The patients were randomized in a 1:1 ratio to intravenous pembrolizumab 200 mg every 21 days plus oral axitinib 5 mg twice daily, or oral sunitinib 50 mg once daily for 28 days. See First-Line Pembrolizumab plus Axitinib Combination Boosts Survival in Metastatic Renal-Cell Carcinoma for further details of this trial.

The results showed a significant improvement in overall survival (OS) for patients who received pembrolizumab plus axitinib. The 12-month OS rate was 89.9% in the combination arm versus 78.3% in the sunitinib arm. The median OS was not reached in either arm. In addition, pembrolizumab plus axi­tinib also led to improvement in progression-free survival (PFS). The median PFS was 15.1 months for patients who received pembrolizu­mab plus axitinib versus 11.1 months for those who received sunitinib.

Grade 3 or 4 hepatotoxicity occurred in 20% of patients, which led to permanent discontinuation of pembrolizumab or axitinib in 13% of patients. The most common (>20%) adverse effects reported with the combination regimen were diarrhea, fatigue/asthenia, hypertension, hypothyroidism, decreased appetite, hepatotoxicity, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation.

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