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- Title
Avelumab Plus Axitinib as First-Line Therapy for Advanced Renal Cell Carcinoma: Long-Term Results from the JAVELIN Renal 100 Phase Ib Trial.
- 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; Pietro, Alessandra di; Choueiri, Toni K
- 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).
- Subjects
THERAPEUTIC use of antineoplastic agents; RENAL cell carcinoma; RESEARCH; DRUG efficacy; HUMAN research subjects; CONFIDENCE intervals; ANTINEOPLASTIC agents; TREATMENT duration; RANDOMIZED controlled trials; INFORMED consent (Medical law); PEARSON correlation (Statistics); KAPLAN-Meier estimator; DESCRIPTIVE statistics; RESEARCH funding; STATISTICAL sampling; DRUG side effects; PROGRESSION-free survival; ODDS ratio; PATIENT safety; OVERALL survival; PHARMACODYNAMICS
- Publication
Oncologist, 2023, Vol 28, Issue 4, p333
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1093/oncolo/oyac243