The Food and Drug Administration has approved Bavencio (avelumab; EMD Serono), a programmed death-ligand 1 (PD-L1) blocking antibody, in combination with Inlyta (axitinib; Pfizer), a kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
The approval was based on data from the phase 3 JAVELIN Renal 101 study which evaluated the combination therapy in 886 patients with advanced RCC regardless of tumor PD-L1 expression (intent-to-treat [ITT] population). Patients were randomized to receive either avelumab plus axitinib or sunitinib monotherapy. The primary efficacy outcome measures were progression-free survival (PFS) and overall survival (OS).
Results showed that avelumab plus axitinib significantly improved median PFS compared with sunitinib (13.8 months vs 8.4 months) in the ITT patient population (HR: 0.69 [95% CI: 0.56–0.84]; 2-sided P =.0002). With a median OS follow-up of 19 months, OS data were immature with 27% deaths in the ITT population.
The most common adverse reactions associated with the combination therapy in the study were diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain, and headache.
“With today’s 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 VEGFR TKI to provide a significant reduction in the risk of disease progression or death and doubling of the response rate compared with sunitinib,” said Robert J. Motzer, MD, Jack and Dorothy Byrne Chair in Clinical Oncology, Memorial Sloan Kettering Cancer Center, New York, US, and principal investigator for JAVELIN Renal 101.
In addition to RCC, Bavencio is also approved to treat metastatic Merkel cell carcinoma and locally advanced or metastatic urothelial carcinoma.
For more information visit bavencio.com.