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2019 GU Cancers Symposium: JAVELIN Renal 101: Avelumab Plus Axitinib vs Sunitinib for Advanced Kidney Cancer

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Key Points

  • Median PFS 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 PFS 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.

A combination of two drugs could become a new standard first-line treatment for patients with metastatic kidney cancer, according to results from the JAVELIN Renal 101 trial presented at the 2019 Genitourinary Cancers Symposium (Abstract 544) and simultaneously published in The New England Journal of Medicine.

Patients who received avelumab, a programmed cell death-ligand 1 (PD-L1) inhibitor, plus axitinib, a vascular endothelial growth factor (VEGF) targeted agent, had a significant advantage in progression-free survival compared with those who received sunitinib, a VEGF-targeted drug that has been a standard treatment for advanced clear cell renal cell carcinoma.

“Patients receiving the drug combination also had a higher response rate than the sunitinib-only group,” said Toni K. Choueiri, MD, senior and co-corresponding author of the report and Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute. “This is certainly better than sunitinib—hopefully this will lead to U.S. Food and Drug Administration approval soon,” said Dr. Choueiri, who is also The Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School.

While progression-free survival was improved with the combination treatment, additional follow-up is needed to show whether the two-drug therapy extends overall survival compared to the standard regimen.

JAVELIN Renal 101

The trial is the first pivotal study to combine avelumab with a drug that targets the VEGF receptor (VEGFR).

The clinical trial involved 886 patients with previously untreated, advanced renal cell carcinoma who were randomly assigned to receive the avelumab/axitinib combination or sunitinib alone.

The results from this study showed that the median progression-free survival (PFS) 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 PFS 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.

Nearly all patients in both treatment groups experienced some side effects. In the combination treatment group, 38.2% of patients experienced immune-related adverse events, the most frequent being thyroid disorders, observed in 107 patients.

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. The study authors' full disclosures can be found at coi.asco.org and nejm.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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