Combination Therapy Improves Progression-Free Survival for Untreated Kidney Cancer
Avelumab, an immune checkpoint inhibitor, in combination with axitinib, a tyrosine kinase inhibitor, significantly improved progression-free survival in untreated renal cell carcinoma.
Avelumab, an immune checkpoint inhibitor, in combination with axitinib, a tyrosine kinase inhibitor (TKI), significantly improved progression-free survival (PFS) in untreated renal cell carcinoma (RCC), according to clinical trial data presented at the European Society for Medical Oncology (ESMO) 2018 Congress.
The prognosis for patients with advanced RCC is poor, with less than 10% surviving at 5-years post-diagnosis, indicating a need for more effective therapies.
The phase 3 JAVELIN Renal 101 global study evaluated avelumab plus axitinib compared with TKI sunitinib alone in the first-line treatment of advanced RCC in 866 patients. In the trial, 442 patients received avelumab at 10 mg/kg intravenously (IV) every 2 weeks in combination with axitinib, 5 mg orally twice daily. In the comparison group, 444 patients received sunitinib at 50 mg orally once per day for 4 weeks, followed by 2 weeks off treatment.
According to the data, median PFS was 13.8 in the combination arm compared with 7.2 months in the sunitinib arm (HR = 0.61; p < .0001) in patients with programmed cell death-ligand 1 positive (PD-L1+) tumors. Median PFS in patients irrespective of PD-L1 expression was 13.8 months versus 8.4 months (HR = 0.69; p = .0001), respectively. The objective response rate for patients treated with the combination therapy was 55.2 (CI 95%: 49.9, 61.2) compared with 25.5 (CI 95%: 20.6, 30.9).