Dr Merseburger on Real-World Outcomes With First-Line Axitinib Plus Avelumab in RCC

“The main goal… [was] to compare data from the JAVELIN Renal 101 trial, which led to the approval of axitinib and avelumab in a lot of countries, [with real-world data.] The results we saw in the clinical trial [vs] real-world data collection [were] consistent…with regard to OS and rPFS.”

Axel Merseburger, MD,PhD, professor, urology; chairman, Department of Urology, University Hospital Schleswig Holstein, Campus Lübeck; director, Urologic Oncology Program, Hannover Medical School, Germany, discusses the real-world efficacy and safety of first-line avelumab (Bavencio) plus axitinib (Inlyta) in patients with advanced renal cell carcinoma, according to data from the prospective noninterventional AVION study.

The phase 3 JAVELIN Renal 101 trial (NCT02684006) demonstrated significantly longer progression-free survival (PFS) and higher objective response rates (ORRs) with axitinib plus avelumab compared with sunitinib (Sutent) in patients with advanced renal cell carcinoma (RCC), Merseburger begins. These data led to regulatory approval of the combination in several countries, he adds.

Recent real-world data from the AVION study corroborated these findings, providing further evidence of the regimen's effectiveness and tolerability in clinical practice, Merseburger states.

At the data cutoff date of July 5, 2024, the median overall survival (OS) in the AVION study had not been reached. However, the 6- and 12-month OS rates were 89.1% (95% CI, 81.2%-93.8%) with axitinib plus avelumab and 82.7% (95% CI, 73.5%-88.9%), respectively, he reports. Patient demographics included individuals with poor prognostic features, reflecting a real-world patient population, Merseburger notes. The median PFS was 11.3 months (95% CI, 8.1-not evaluable); this was also consistent with the results from JAVELIN Renal 101.

The ORR in the AVION study was 46% (95% CI, 35.2%-57.0%), and the disease control rate (DCR) was 79.3% (95% CI, 69.3%-87.3%). Furthermore, the regimen's safety profile was manageable, with grade 3 or higher toxicities occurring at a low frequency, reinforcing the favorable tolerability observed in the pivotal trial, Merseburger says.

The consistency between the AVION real-world data and the JAVELIN Renal 101 trial supports the clinical utility of this combination across diverse patient populations, including those with poor prognostic factors, and confirm its place as a standard-of-care option, Merseburger concludes.