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

• Published in: The oncologist (Dayton, Ohio) Ohio), 2023-04, Vol.28 (4), p.333-340
• Main Authors: Larkin, James, Oya, Mototsugu, Martignoni, Marcella, Thistlethwaite, Fiona, Nathan, Paul, Ornstein, Moshe C, Powles, Thomas, Beckermann, Kathryn E, Balar, Arjun V, McDermott, David, Gupta, Sumati, Philips, George K, Gordon, Michael S, Uemura, Hirotsugu, Tomita, Yoshihiko, Wang, Jing, Michelon, Elisabete, di Pietro, Alessandra, Choueiri, Toni K
• Format: Article
• Language: English
• Subjects: Antibodies, Monoclonal, Humanized - adverse effects; Antimitotic agents; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Axitinib - adverse effects; Biotechnology industry; Carcinoma, Renal cell; Carcinoma, Renal Cell - pathology; Care and treatment; Clinical trials; Genitourinary Cancer; Humans; Immunotherapy; Kidney Neoplasms - pathology; Pharmaceutical industry; Product development
• ISSN: 1083-7159; 1549-490X
• DOI: 10.1093/oncolo/oyac243

Abstract 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 long-term clinical activity with no new safety signals, supporting use of this regimen within its approved indication in clinical practice (Clinicaltrials.gov NCT02493751). Based on the results of the JAVELIN Renal 101 trial, avelumab plus axitinib has been approved as first-line treatment for advanced renal cell carcinoma. To provide long-term safety and efficacy data, this article reports 5-year follow-up results from the JAVELIN Renal 100 phase Ib trial.