Axitinib Plus Pembrolizumab in Advanced Kidney Cancer
The combination of axitinib plus pembrolizumab in previously untreated patients with advanced renal cell carcinoma displayed antitumor activity that is “unprecedented and superior” to that expected from either agent alone, based on findings of the phase Ib published in The Lancet Oncology by Michael B. Atkins, MD, of Georgetown Lombardi Comprehensive Cancer Center, and colleagues. The treatment significantly decreased tumor size in 73% of patients receiving the combination therapy, including 8% with a complete response, and was tolerated by participants.
The multicenter, open-label study enrolled a total of 52 treatment-naive patients, including 11 patients in the 6-week dose-finding phase and 41 patients in the dose-expansion phase. Patients received an intravenous infusion of pembrolizumab at 2 mg/kg at the beginning of the trial and then every 3 weeks thereafter. They were also given axitinib orally at 5 mg twice daily until either disease progressed or they could no longer tolerate the drug.
More than 90% of patients (n = 48) experienced some degree of tumor shrinkage, with a median time to disease progression of 20.9 months. Overall survival results are incomplete, with 88% of patients still alive at a minimum 18 months after starting therapy. Grade 3 or worse treatment-related adverse events were seen in 65% of patients, most commonly hypertension, diarrhea, and fatigue. No unexpected toxicities were observed.
A randomized phase III trial is currently underway to compare the combination with sunitinib monotherapy.