JAVELIN Renal 101: Avelumab Plus Axitinib vs Sunitinib in the First-Line Treatment of Advanced Kidney Cancer

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THE PROGRAMMED cell death-ligand 1 (PD-L1) inhibitor, avelumab, was combined with the multitargeted vascular growth endothelial factor (VEGF) agent, axitinib, and compared to monotherapy with sunitinib in the first-line treatment of patients with metastatic renal cell carcinoma. Toni K. Choueiri, MD, presented a subgroup analysis of the study, called JAVELIN Renal 101, at the 2019 Genitourinary Cancers Symposium.1 A paper on JAVELIN Renal 101 by Robert Motzer, MD, et al was published simultaneously in The New England Journal of Medicine.2 Dr. Motzer presented an earlier report on JAVELIN Renal 101 at the 2018 European Society for Medical Oncology Annual Congress.3 Dr. Choueiri is Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute in Boston. Dr. Motzer is the Jack and Dorothy Byrne Chair in Clinical Oncology at Memorial Sloan Ketter Cancer Center in New York.

Toni K. Choueiri, MD, presents abstract 544 during an oral abstract session at the 2019 Genitourinary Cancers Symposium in San Francisco. Photo by © ASCO/Todd Buchanan 2019.

Patients with metastatic renal cell carcinoma who received the combination of avelumab plus axitinib had a significant advantage in progression-free survival compared with those patients who received sunitinib alone, Dr. Choueiri noted. Further, patients receiving the combination regimen also experienced a higher response rate.

JAVELIN Renal 101

THE JAVELIN Renal 101 trial is the first pivotal study to combine avelumab with a drug that targets the VEGF receptor (VEGFR). A total of 886 patients with previously untreated advanced renal cell carcinoma were randomly assigned to receive the avelumab/axitinib combination or sunitinib alone.

Robert Motzer, MD

Robert Motzer, MD

The results from this study showed that the median progression-free survival was 13.8 months in the combination group and 7.2 months in patients receiving only sunitinib. These results specifically applied to patients whose cancer cells tested positive for the PD-L1 checkpoint that is blocked by avelumab. The progression-free survival for the overall population (PD-L1–positive or PD-L1–negative) was consistent—13.8 months vs 8.4 months.

The objective response rate was 55.2% with avelumab plus axitinib and 25.5% with sunitinib in the patients who were positive for PD-L1.

“Interestingly, the analysis showed that all subgroups—favorable-, intermediate-, and poor-risk … benefited from the combination treatment,” said Dr. Choueiri. He noted that additional follow-up is needed to show whether the two-drug therapy extends overall survival compared to the standard regimen.

“These treatments may not be curative, but patients are living longer, and the disease is becoming more chronic.”
— Toni K. Choueiri, MD

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Nearly all patients in both treatment groups experienced some side effects. In the combination group, 38.2% experienced immune-related adverse events, the most frequent being thyroid disorders. Dr. Choueiri said that for patients with advanced disease, “This is an important option. What we’re doing in advanced kidney cancers is pushing the envelope—these treatments may not be curative, but patients are living longer, and the disease is becoming more chronic.”

DISCLOSURES: The clinical trial is sponsored by Pfizer, Inc., and is part of an alliance between Pfizer and Merck KGaA. Dr. Choueiri has received grants and personal fees from AstraZeneca, Bristol-Myers Squibb, Eisai, Exelixis, GlaxoSmithKline, Merck, Novartis, Pfizer, Peloton, and Roche/Genentech, personal fees from Bayer, Cerulean, Corvus, Foundation Medicine, and Prometheus Laboratories, and grants from Tracon. Dr. Motzer has had a consulting or advisory role for Eisai, Exelixis, Merck, Novartis, and Pfizer, and has received research funding from Bristol-Myers Squibb, Eisai, Genentech/Roche, GlaxoSmithKline, Novartis, and Pfizer. Full disclosures for all of the study authors can be found at and


1. Choueiri TK, Motzer RJ, Campbell MT, et al: Subgroup analysis from JAVELIN Renal 101. 2019 Genitourinary Cancers Symposium. Abstract 544. Presented February 16, 2019.

2. Motzer RJ, Penkov K, Haanen J, et al. Avelumab plus axitinib vs sunitinib for advanced renal cell carcinoma. N Engl J Med. February 16, 2019 (early release online).

3. Motzer RJ: JAVELIN Renal 101. Late-Breaking Abstract 6-PR. 2018 European Society for Medical Oncology Congress. Presented October 21, 2018.