Combination Therapy for Patients with Advanced Renal Cell Carcinoma Granted FDA Approval


This is the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC, according to EMD Serono.

Officials with the FDA have approved avelumab (Bavencio, EMD Serono and Pfizer) in combination with axitinib (Inlyta, Pfizer) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

This is the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC, according to EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany.

According to Dena Battle, President, KCCure, the new FDA approval provides needed options to patients with advanced RCC.

"A kidney cancer diagnosis is life-changing for both patients and their loved ones, and having a treatment strategy for their disease quickly becomes a priority," said Battle, in a prepared statement.

There is a significant unmet need for first-line treatments that delay progression and have an acceptable safety profile, according to EMD Serono. Approximately 20% to 30% of patients are first diagnosed with RCC at the advanced stage, and 30% of patients treated for an earlier stage go on to develop metastases. About half of patients living with advanced RCC do not receive additional treatment after first-line therapy, due to poor performance status or adverse events from their initial treatment, in many cases.

The 5-year survival rate for patients with metastatic RCC is approximately 12%, according to EMD Serono.

The approval of avelumab in combination with axitinib was based on positive results from the Phase III JAVELIN Renal 101 study

"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, US, and principal investigator for JAVELIN Renal 101, in a prepared statement. "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."

The Phase III JAVELIN Renal 101 study found the combination of avelumab with axitinib significantly improved median progression-free survival (PFS) compared with sunitinib by more than 5 months in the intent-to-treat (ITT) patient population (HR: 0.69 [95% CI: 0.56—0.84]; 2-sided p-value=0.0002; median PFS for avelumab in combination with INLYTA: 13.8 months [95% CI: 11.1-NE]; sunitinib: 8.4 months [95% CI: 6.9-11.1]). The ITT population included patients regardless of PD-L1 expression and across IMDC (International Metastatic Renal Cell Carcinoma Database) prognostic risk groups (favorable 21%, intermediate 62% and poor 16%).1


FDA Approves BAVENCIO® (avelumab) Plus INLYTA® (axitinib) Combination for Patients with Advanced Renal Cell Carcinoma [news release]. Rockland, MA and New York, NY; May 14, 2019: EMD Serono. Accessed May 15, 2019.

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