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2019 GU Symposium: Subgroup Analysis of Avelumab + Axitinib in JAVELIN Renal 101 Trial

By: Joseph Fanelli
Posted: Tuesday, March 5, 2019

In the ongoing phase III JAVELIN Renal 101 trial, the combination of avelumab and axitinib yielded improvements in progression-free survival and overall response in patients with renal cell carcinoma across all prognostic risk groups and PD-L1 subgroups compared with sunitinib, according to findings presented at the 2019 Genitourinary Cancers Symposium (Abstract 544) in San Francisco. According to the senior author, Toni K. Choueiri, MD, of the Dana-Farber Cancer Institute, this combination therapy represents an “important option” for patients with advanced disease, although additional follow-up is needed to determine whether it improves overall survival.

“There is a significant need for patients with advanced [renal cell carcinoma] to prolong the time until the disease worsens beyond what tyrosine kinase inhibitors alone offer,” said coauthor Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, in a press release. “The magnitude and consistency of [progression-free survival] and response rates seen thus far across populations in the JAVELIN Renal 101 study suggest that many different types of patients, including those with a favorable prognosis, could potentially derive benefit from this particular combination.”

A total of 886 patients with renal cell carcinoma were randomly assigned evenly to receive 10 mg/kg of avelumab every 2 weeks plus 5 mg of axitinib twice daily or 50 mg of sunitinib once daily for 4 weeks. The combination therapy extended the median progression-free survival by more than 5 months compared with sunitinib (13.8 months vs. 8.4 months, respectively), and the objective response rate was doubled with avelumab plus axitinib (52.2% vs. 25.5%)—irrespective of PD-L1 expression.

As for safety, some side effects were reported by nearly all patients in both treatment groups. Of those treated with the combination therapy, 38.2% experienced immune-related adverse events, with the most frequent being thyroid disorders.

Disclosure: The study authors’ disclosure information may be found at coi.asco.org.



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