Darmstadt, Germany & New York, NY, USA – May 14, 2019 – Merck KGaA, Darmstadt, Germany (operating its biopharma business in the U.S. and Canada as EMD Serono) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Bavencio (avelumab) in combination with Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
This marks the first FDA approval of an anti‑PD‑L1 therapy as part of a combination regimen for advanced kidney cancer. The approval was based on positive results from the Phase III JAVELIN Renal 101 study (NCT02684006). In the intent‑to‑treat (ITT) population, the combination significantly prolonged median progression‑free survival (PFS) by more than 5 months compared with sunitinib:
Hazard Ratio (HR): 0.69 [95% CI: 0.56–0.84]
Two‑sided p‑value: 0.0002
Median PFS: 13.8 months for the combination arm [95% CI: 11.1‑NE] vs. 8.4 months for sunitinib [95% CI: 6.9‑11.1]
The ITT population included patients across all PD‑L1 expression levels and all IMDC (International Metastatic Renal Cell Carcinoma Database Consortium) prognostic risk groups (21% favorable, 62% intermediate, 16% poor).
Expert Perspective and Clinical Significance
“As we continue to advance outcomes for patients with advanced kidney cancer, new treatment approaches hold the potential to benefit patients,” said Dr. Robert J. Motzer, Jack and Dorothy Byrne Professor of Clinical Oncology at Memorial Sloan Kettering Cancer Center and lead investigator of the JAVELIN Renal 101 study. “With today’s FDA approval of avelumab plus axitinib, we now offer a first‑line option for patients with advanced RCC that combines PD‑L1 immunotherapy with a well‑established VEGFR tyrosine kinase inhibitor (TKI). This regimen significantly reduces the risk of disease progression or death and doubles the response rate compared with sunitinib.”
Renal cell carcinoma is a cancer type in which PD‑L1 expression can contribute to suppression of anti‑tumor immune responses. It is also a highly vascularized tumor, in which vascular endothelial growth factor (VEGF) plays a key role.
Clinical Context and Unmet Need
“A kidney cancer diagnosis is life‑changing for patients and their loved ones, and developing a treatment strategy quickly becomes a top priority,” said Dena Battle, President of KCCure. “The benefits of new therapies such as Bavencio plus Inlyta provide much‑needed options for those living with advanced kidney cancer.”
There remains a significant unmet medical need for regimens that delay disease progression while maintaining a favorable safety profile. Approximately 20–30% of patients present with advanced disease at initial diagnosis, and another 30% of patients treated for early‑stage disease will develop metastases. About half of patients with advanced RCC do not receive subsequent therapy after first‑line treatment, often due to poor performance status or adverse events from first‑line therapy.
