Avelumab Plus Axitinib as First-Line Therapy for Advanced Renal Cell Carcinoma: Long-Term Results from the JAVELIN Renal 100 Phase Ib Trial

James Larkin, Mototsugu Oya, Marcella Martignoni, Fiona Thistlethwaite, Paul Nathan, Moshe C. Ornstein, Thomas Powles, Kathryn E. Beckermann, Arjun V. Balar, David McDermott, Sumati Gupta, George K. Philips, Michael S. Gordon, Hirotsugu Uemura, Yoshihiko Tomita, Jing Wang, Elisabete Michelon, Alessandra Di Pietro, Toni K. Choueiri

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)


Background: Progression-free survival was significantly longer in patients who received avelumab plus axitinib versus sunitinib as first-line treatment for advanced renal cell carcinoma (aRCC) in a randomized phase III trial. We report long-term safety and efficacy of avelumab plus axitinib as first-line treatment for patients with aRCC from the JAVELIN Renal 100 phase Ib trial (NCT02493751). Materials and Methods: In this open-label, multicenter, phase Ib study, patients with untreated aRCC received avelumab 10 mg/kg every 2 weeks plus axitinib 5 mg twice daily or with axitinib for 7 days followed by avelumab plus axitinib. Safety and efficacy were assessed in all patients receiving at least one dose of avelumab or axitinib. Results: Overall, 55 patients were enrolled and treated. Median follow-up was 55.7 months (95% CI, 54.5-58.7). Treatment-related adverse events of any grade or grade ≥3 occurred in 54 (98.2%) and 34 (61.8%) patients, respectively. The confirmed objective response rate was 60.0% (95% CI, 45.9-73.0), including complete response in 10.9% of patients. Median duration of response was 35.9 months (95% CI, 12.7-52.9); the probability of response was 65.8% (95% CI, 46.7-79.4) at 2 years. Median progression-free survival was 8.3 months (95% CI, 5.3-32.0). Median overall survival was not reached (95% CI, 40.8-not estimable); the 5-year overall survival rate was 57.3% (95% CI, 41.2-70.5). Conclusion: Five-year follow-up for combination treatment with avelumab plus axitinib in previously untreated patients with aRCC showed longterm clinical activity with no new safety signals, supporting use of this regimen within its approved indication in clinical practice (Clinicaltrials. gov NCT02493751).

Original languageEnglish
Pages (from-to)333-340
Number of pages8
Issue number4
Publication statusPublished - 2023 Apr


  • clinical trials as topic
  • drug therapy
  • immunotherapy
  • kidney neoplasms

ASJC Scopus subject areas

  • General Medicine


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