The Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab; Merck) in combination with axitinib (Inlyta; Pfizer), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The approval was based on data from the KEYNOTE-426 trial, an open-label study conducted in 861 patients who had not received systemic therapy for advanced RCC. Patients were randomized to receive either Keytruda in combination with axitinib or sunitinib monotherapy; tumor status assessment was performed at baseline, at Week 12, and then every 6 weeks thereafter until Week 54, and then every 12 weeks thereafter. The primary efficacy measures were overall survival (OS) and progression-free survival (PFS); objective response rate was an additional efficacy measure.

Results showed that a statistically significant improvement in OS was demonstrated in patients treated with Keytruda plus axitinib compared with sunitinib (hazard ratio [HR] 0.53 [95% CI, 0.38-0.74]; P <.0001); a statistically significant improvement in PFS was also observed with the combination vs sunitinib (PFS: HR 0.69 [95% CI, 0.57-0.84]; P =.0001). In addition, ORR was 59% for patients who received Keytruda plus axitinib (95% CI, 54-64) compared with 36% for those who received sunitinib (95% CI, 31-40) (P <.0001).

With regard to safety, the most common adverse reactions associated with the combination therapy included diarrhea, fatigue/asthenia, hypertension, hepatotoxicity, hypothyroidism, decreased appetite, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation.


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Keytruda, an anti-PD-1 therapy, is already approved to treat various skin, lung, head and neck, urothelial, hematologic, gastrohepatic, and gynecologic cancers. “Pembrolizumab in combination with axitinib offers an important new therapeutic option for physicians to consider when approaching initial treatment for patients newly diagnosed with advanced renal cell carcinoma,” said Dr Brian Rini, medical oncologist at Cleveland Clinic Cancer Center and professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University.

Keytruda is available as 50mg/vial strength lyophilized powder for IV infusion after reconstitution and as a 25m/gmL strength solution for IV infusion after dilution in single-use vials.

For more information call visit Keytruda.com.