Nivolumab is the first immune checkpoint inhibitor approved in Europe for the treatment of advanced renal cell carcinoma (aRCC) in patients resistant to prior antiangiogenic therapy. WITNESS is an ongoing, prospective, observational study designed to evaluate the effectiveness and safety of nivolumab in patients with aRCC treated in real life (or routine practice) in France (ClinicalTrials. gov identifier: NCT03455452).
This study includes adult patients with a confirmed diagnosis of aRCC who have initiated nivolumab after 1-2 prior lines of antiangiogenic therapy. Endpoints include overall survival (OS), progression-free survival (PFS), duration of treatment (DOT), duration of response (DOR), overall response rate (ORR), subgroup analyses, and treatment-related adverse events (TRAEs). Results after a median follow-up of 12.3 months are presented here.
A total of 325 patients with aRCC were included, of whom 38.2% had a Karnofsky score <80, 77.8% received nivolumab as second-line therapy, and 69.5% had undergone a previous nephrectomy. In the overall population, median OS was 20.5 [95% confidence interval (CI) 17.6-25.0] months and median PFS was 5.2 (95% CI 4.5-5.9) months. ORR was 34.5%, median DOT was 3.8 months, and median DOR was 16.5 months. Nivolumab was effective in different subgroups including patients with bone or glandular metastases and those receiving baseline corticosteroids. Moreover, effectiveness was observed irrespective of prior nephrectomy and line of treatment. No new safety signals were identified; TRAEs of any grade were reported in 32.0% of patients, grade ≥3 and serious TRAEs in 11.1% each, and TRAEs leading to discontinuation in 8.9%.
Preliminary results of the ongoing WITNESS study confirm the real-world effectiveness and safety of nivolumab monotherapy in previously treated patients with aRCC. Treatment benefits were similar to those observed in the pivotal phase III CheckMate 025 randomized clinical trial, despite a broader, real-life study population.
ESMO open. 2024 Jun 18 [Epub ahead of print]
P Barthélémy, L Albigès, B Escudier, B Narciso, P Bigot, M Chehimi, S Emambux, F Calcagno, G Mouillet, J-C Eymard, F Schlürmann, S Bailly, D Garbay, J-F Berdah, M B Palmaro, M G Goupil, D Spaeth, S Néré, C Quentric, Y-A Vano, A Thiery-Vuillemin
Department of Medical Oncology, Institut de Cancérologie Strasbourg Europe, Strasbourg. Electronic address: ., Department of Medical Oncology, Gustave Roussy Cancer Campus, Paris., Department of Medical Oncology, Centre Hospitalier Universitaire de Tours, Tours., Department of Urology, Centre Hospitalier Universitaire d'Angers, Angers., Department of Medical Oncology and Hematology, Centre Hospitalier de Saint-Quentin, Saint-Quentin., Department of Medical Oncology, Centre Hospitalier Universitaire de Poitiers, Poitiers., Department of Medical Oncology, Centre Hospitalier Universitaire de Besançon, Besançon., Department of Medical Oncology, Institut Jean Godinot, Reims CEDEX., Department of Medical Oncology, Centre Hospitalier Intercommunal Quimper, Quimper., Department of Thoracic Oncology, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand., Department of Medical Oncology, Clinique Tivoli-Ducos, Bordeaux., Department of Medical Oncology and Radiotherapy, Hôpital privé Toulon Hyères-Sainte Marguerite, Hyères., Department of Medical Oncology, Hôpital Nord, Marseille., Department of Medical Oncology, Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux., Department of Medical Oncology, Polyclinique de Gentilly, Nancy., Department of Medical Affairs, Bristol Myers Squibb, Paris., Department of Medical Oncology, Hôpital Européen Georges Pompidou, APHP Centre-Université de Paris, Paris, France.