On May 14, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio) in combination with axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti–programmed cell death ligand 1 (PD-L1) therapy as part of a combination regimen for patients with advanced RCC.
JAVELIN Renal 101
The approval of avelumab in combination with axitinib was based on positive results from the phase III JAVELIN Renal 101 study (ClinicalTrials.gov identifier NCT02684006), in which the combination significantly improved median progression-free survival compared with sunitinib by more than 5 months in the intent-to-treat patient population (hazard ratio [HR] = 0.69, 95% confidence interval [CI] = 0.56–0.84; 2-sided P value = .0002; median progression-free survival for avelumab plus axitinib: 13.8 months [95% CI = 11.1–not estimated]; median progression-free survival for sunitinib = 8.4 months [95% CI = 6.9–11.1]). The intent-to-treat population included patients regardless of PD-L1 expression and across International Metastatic Renal Cell Carcinoma Database prognostic risk groups.
Robert J. Motzer, MD
“As we look to continue to improve outcomes for people with advanced RCC, new treatment approaches have the potential to benefit patients,” said Robert J. Motzer, MD, Jack and Dorothy Byrne Chair in Clinical Oncology, Memorial Sloan Kettering Cancer Center, New York, and principal investigator for JAVELIN Renal 101. “With the FDA approval of avelumab in combination with axitinib, we can now offer patients with advanced RCC a first-line treatment option that combines a PD-L1 immunotherapy with a well-known [vascular endothelial growth factor receptor tyrosine kinase inhibitor] to provide a significant reduction in the risk of disease progression or death and doubling of the response rate compared with sunitinib.”
For more information, visit FDA.gov. ■