Real-World Data Support First-Line Avelumab Plus Axitinib in Advanced RCC

A real-world analysis of avelumab and axitinib to treat advanced renal cell carcinoma supports the frontline use of the combination and confirmed the findings of JAVELIN Renal 101 (NCT02684006), said Axel Merseburger, MD, professor of urology and chairman of the Department of Urology, University Hospital Schleswig Holstein, Campus Lübeck, and director of the Urologic Oncology Program, Hannover Medical School in Germany.

Merseburger presented these findings at the American Society of Clinical Oncology Genitourinary Cancers Symposium, held February 13-15, 2025, in San Francisco, California.

This transcript has been edited for clarity; captions were auto-generated.

Transcript

What was the rational for conducting the AVION study, a real-world analysis of avelumab and axitinib for renal cell carcinoma?

The rationale and the idea was we have the approval in a lot of countries for avelumab and axitinib for treating advanced and metastatic renal cell carcinoma, and we wanted to have a look at if this trial data, which was published and shown at several conferences, would stand also in real-world data in countries like Russia, Greece, and Germany that were the countries included in the AVION trial.

Were there any notable differences in outcomes or adverse events between the real-world study and what was seen in JAVELIN Renal 101?

Now, fortunately not, and this was really real life in European and even Russian sites that recruited the patients. Some of them haven't had any access to further subsequent treatment, which probably resulted also in this overall survival, similar to JAVELIN Renal 101.¹

I think no, there's not a big difference, and the real-world data supports what we have found in the pivotal trial.

The observation period was 24 months. Is there a need for a longer follow-up period and what might it tell us or confirm?

Yes, we will do the follow-up. We will continue to do the follow-up and hope to report maybe at next year's ASCO GU 2026. Also, the publication plan is there. And once we have had more follow-up data, it's going to be published in a journal. We don't know where yet, but it's going to be definitely published.

Reference

Motzer RJ, Penkov K, Haanen J, et al. Avelumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2019;380(12):1103-1115. doi:10.1056/NEJMoa1816047