Avelumab/axitinib combination therapy demonstrated promising antitumor activity and safety in treatment-naive patients with advanced renal cell carcinoma (RCC), according to a study published in The Lancet Oncology.1

For the phase 1b JAVELIN Renal 100 study (ClinicalTrials.gov Identifier: NCT02493751), researchers enrolled 6 and 49 patients into dose-finding and dose expansion stages, respectively. Eligible patients had advanced RCC with a clear-cell component, were treatment-naive, and had undergone primary tumor resection.

Patients enrolled in the dose-finding stage received oral axitinib monotherapy twice daily for 1 week, followed by intravenous avelumab every 2 weeks plus axitinib twice daily. The median follow-up was 69.7 weeks.

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Grade 3 or 4 treatment-related adverse events (AEs), including hypertension, lipase concentration increase, mucosal inflammation, and proteinuria, were observed in 4 of 6 patients. Only grade 3 proteinuria was, however, dose-limiting. The maximum tolerated dose was defined at avelumab 10 mg/kg every 2 weeks and axitinib 5 mg twice daily.

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All included patients experienced at least 1 AE; 53 patients (95%) experienced AEs determined to be treatment-related. Thirty-two (58%) patients experienced grade 3 or worse AEs, including diarrhea, hypertension, infusion-related reactions, palmar-plantar erythrodysesthesia syndrome, increased alanine aminotransferase and aspartate aminotransferase concentration, immune-related AEs, and rash.

Five (9%) patients died because of disease progression and 1 (2%) because of treatment-related autoimmune myocarditis.

All 6 patients in the dose-finding arm and 26 (53%) patients in the dose expansion arm had a confirmed objective response.

The authors concluded that “the overall response and durability of responses in our study are encouraging and warrant further study of this drug combination.” A phase 3 study assessing avelumab plus axitinib vs sunitinib as first-line therapy is ongoing.


  1. Choueiri TK, Larkin J, Oya M, et al. Preliminary results for avelumab plus axitinib as first-line therapy in patients with advanced clear-cell renal-cell carcinoma (JAVELIN Renal 100): an open-label, dose-finding and dose expansion, phase 1b trial. Lancet Oncol. 2018 Mar 9. Doi: 10.1016/S1470-2045(18)30107-4 [Epub ahead of print]