Combination avelumab and axitinib has shown long-term activity in previously untreated patients with advanced renal cell carcinoma (RCC), according to research published in The Oncologist.

A 5-year update of the JAVELIN Renal 100 trial showed durable responses and no new safety signals with the combination, researchers reported. 

The phase 1b trial ( Identifier: NCT02493751) included 55 patients with previously untreated, advanced RCC. At baseline, the median age was 60 (range, 42-76) years, 76.4% of patients were men, 80.0% were White, and all had an ECOG performance status of 0 (65.5%) or 1 (34.5%). 

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Patients enrolled in the dose-finding phase of this study received axitinib at 5 mg twice daily for 7 days, followed by combination avelumab at 10 mg/kg every 2 weeks and axitinib at 5 mg twice daily. Patients enrolled in the dose-expansion phase either received the combination at the start of treatment or received axitinib alone followed by the combination. Treatment was continued until disease progression, unacceptable toxicity, withdrawal, or loss to follow-up.

A total of 39 patients (70.9%) received anticancer treatment after discontinuing the study treatment. The most common subsequent treatments were cabozantinib (30.9%), nivolumab (23.6%), and axitinib (18.2%).

The median follow-up was 55.7 months. The median duration of avelumab treatment was 10.4 months, and the median duration of axitinib treatment was 10.6 months.

The objective response rate was 60.0%, and 10.9% of patients achieved a complete response. There were 3 patients who had a partial response in the initial analysis that became a complete response with longer follow-up. One patient who initially had stable disease later achieved a partial response.

The median duration of response was 35.9 months. The median progression-free survival (PFS) was 8.3 months, and the median overall survival (OS) was not reached. 

The 2-year PFS rate was 41.1%, and the 4-year PFS rate was 25.6%. The 2-year OS rate was 72.4%, the 4-year OS rate was 61.1%, and the 5-year OS rate was 57.3%.

Treatment-related adverse events (TRAEs) of any grade occurred in 98.2% of patients. TRAEs of grade 3 or higher occurred in 61.8%. The most common grade 3 or higher TRAEs were hypertension (27.3%), lipase increase (9.1%), and palmar-plantar erythrodysesthesia syndrome (9.1%). 

TRAEs prompted discontinuation of avelumab in 10 patients (18.2%) and discontinuation of axitinib in 5 patients (9.1%). The most common TRAEs leading to discontinuation were increased alanine aminotransferase level (n=3) for avelumab and proteinuria (n=2) for axitinib. 

There was 1 fatal TRAE — autoimmune myocarditis — but this was previously reported.

“Extended follow-up with the combination of avelumab plus axitinib in treatment-naïve patients with advanced renal cell carcinoma showed long-term clinical benefits with no new safety signals, supporting the use of this treatment regimen within its approved indication in clinical practice,” the researchers concluded.

Disclosures: This research was supported by Pfizer. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Larkin J, Oya M, Martignoni M, et al. Avelumab plus axitinib as first-line therapy for advanced renal cell carcinoma: Long-term results from the JAVELIN Renal 100 phase Ib trial. Published online December 28, 2022.

This article originally appeared on Cancer Therapy Advisor