Background/Objectives: Nivolumab monotherapy is a standard of care in previously treated advanced renal cell carcinoma (aRCC) and was approved based on the results of the randomized clinical trial Checkmate-025. The non-interventional study (NIS) NORA collected data on the effectiveness and safety of nivolumab monotherapy in real-world clinical routine. Its final, long-term follow-up data are presented here. Methods: NORA was a prospective, multicentre NIS recruiting at 54 German sites, evaluating the effectiveness and safety of nivolumab monotherapy in pre-treated patients with aRCC. Endpoints included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), safety, and patient-reported outcomes (PROs). Results: A total of 232 patients were eligible. Of the patients, 15% had favourable, 58% had intermediate, and 15% had poor risk according to the International Metastatic RCC Database Consortium. Of the patients, 77% received nivolumab as second-line, 15% as third-line, and 8% as ≥fourth-line therapy. With a median long-term follow-up of 76 months (minimum 62 months), median OS was 22.2 months (95% confidence interval [CI] 16.5-25.9) and median PFS was 4.1 months (95% CI 3.2-5.4). The ORR was 21% with a median DOR of 27.9 months (95% CI 15.9-not evaluable). Of the patients, 47% and 16% had treatment-related adverse events of all grades and of grades 3-4, respectively. One patient died from autoimmune hepatitis related to treatment. PROs did not reveal any new signals. Conclusions: The long-term follow-up of NORA confirms that nivolumab monotherapy is an effective and safe therapy in patients with aRCC after prior therapy. With comparable follow-up times, our real-world data were not substantially different from the final long-term results of the pivotal Checkmate-025 study.
Cancers. 2026 Jun 26*** epublish ***
Marc-Oliver Grimm, Viktor Grünwald, Harald Müller-Huesmann, Philipp Ivanyi, Martin Schostak, Eyck von der Heyde, Wolfgang Schultze-Seemann, Holger Schulz, Martin Bögemann, Stefan Wolfgang Grötzinger, Luis Vaz, Martin Herber, Jens Bedke
Department of Urology, Jena University Hospital, Friedrich-Schiller University Jena, 07747 Jena, Germany., Clinic for Medical Oncology and Clinic for Urology, West-German Cancer Center Essen, Essen University Hospital, 45147 Essen, Germany., Department of Internal Medicine, Hematology and Oncology, St Josef Brothers Hospital, 33098 Paderborn, Germany., Clinic Department of for Hematology, Hemostaseology, Oncology and Stem Cell Transplantation, Interdisciplinary Oncologic Outpatient Clinic (OIA), Hannover Medical School, 30625 Hannover, Germany., LOGICURO GmbH, 14482 Potsdam-Babelsberg, Germany., Practice for Oncology Raschplatz, 30161 Hannover, Germany., Department of Urology, Freiburg University Hospital, 79106 Freiburg, Germany., Practice for Medical Oncology and Hematology, 50226 Frechen, Germany., Department of Urology, Münster University Hospital, 48149 Münster, Germany., Bristol Myers Squibb Germany, 80636 Munich, Germany., Bristol Myers Squibb UK, Uxbridge UB11 1AF, UK., Department of Urology and Transplant Surgery, Stuttgart Hospital, 70174 Stuttgart, Germany.