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Eur Urol Focus: What is the efficacy of nivolumab monotherapy in advanced renal cell carcinoma?

 Last Update: 2022-03-04
 Source: Internet
 Author: User

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The European Medicines Agency approved the immune checkpoint inhibitor (ICI) nivolumab in 2016 as the first antibody targeting PD-1 for the treatment of advanced renal cell carcinoma (aRCC) after prior therapy .
The decision was based on the results of the pivotal Phase 3 CheckMate 025 (CM025) randomized clinical trial (RCT) .

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Recently, researchers from Germany, published in Eur Urol Focus, conducted the NORA (NivOlumab in Renal cell cArcinoma) non-interventional study (NIS), which aims to obtain real-world data to complement the pivotal CheckMate 025 Clinical trial results
.

Conducted the NORA (NivOlumab in Renal cell cArcinoma) non-interventional study (NIS) designed to obtain real-world data to complement the pivotal CheckMate 025 clinical trial results Conducted the NORA (NivOlumab in Renal cell cArcinoma) non-interventional study (NIS), the study aims to acquire real-world data to complement pivotal CheckMate 025 clinical trial results

NORA is a prospective, multicenter NIS conducted in Germany
.

Patients with any subtype of RCC who received nivolumab after prior therapy were eligible for inclusion

statistics

In total, 228 aRCC patients were eligible
.

The median age was 70 years, 71% were male, 14% had favorable risk, 58% had intermediate risk, and 15% had poor International Metastatic RCC Database Consortium risk (12% missing information)

Antitumor activity of nivolumab monotherapy

Taken together, the efficacy and safety profile in this real-world population is consistent with the results of the pivotal clinical trial and supports the use of nivolumab after prior systemic therapy in the broad aRCC population

Efficacy and safety in this real-world population are consistent with the results of the pivotal clinical trial and support the efficacy and safety of nivolumab in this real-world population after prior systemic therapy in the broad aRCC population Clinical trial results are consistent and support the use of nivolumab after prior systemic therapy in the broad aRCC population

Original source:

Marc-Oliver Grimm, Viktor Grünwald, Harald Müller-Huesmann et al.

Real-World Data on the Use of Nivolumab Monotherapy in the Treatment of Advanced Renal Cell Carcinoma after Prior Therapy: Interim Results from the Noninterventional NORA Study

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