Real-World Data on the Use of Nivolumab Monotherapy in the Treatment of Advanced Renal Cell Carcinoma After Prior Therapy: Final Results from the Non-Interventional NORA Study.

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.