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).
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.
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).
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).
The oncologist. 2022 Dec 28 [Epub ahead of print]
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
Department of Medical Oncology, Royal Marsden NHS Foundation Trust, London, UK., Department of Urology, Keio University Hospital, Tokyo, Japan., Clinical Development and Operations, Pfizer, Milan, Italy., The Christie NHS Foundation Trust, Manchester, UK., Department of Medical Oncology, Mount Vernon Cancer Centre, Northwood, UK., Department of Hematology and Medical Oncology, Cleveland Clinic, Cleveland, OH, USA., Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew's Hospital, London, UK., Department of Internal Medicine, Vanderbilt University Medical Center, Nashville, TN, USA., Department of Medicine, Perlmutter Cancer Center at NYU Langone Health, New York, NY, USA., Department of Medical Oncology, Beth Israel Deaconess Medical Center, Boston, MA, USA., Department of Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA., Department of Medicine, Georgetown University Medical Center, Washington, DC, USA., Division of Cancer Research, HonorHealth Research Institute, Scottsdale, AZ, USA., Department of Medicine, Kindai University Hospital, Osaka, Japan., Department of Urology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan., Biostatistics, Pfizer, Cambridge, MA, USA., Safety Surveillance & Risk Management, New York, NY, USA., Global Product Development, Pfizer, Milan, Italy., Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.