Between 2016-2017, 729 patients were enrolled across 27 institutions, and 720 patients treated with nivolumab were included in the final analysis. All patients had clear cell mRCC. The patient characteristics and adverse events are summarized in the table below.
Median follow up was 20.9 months, median duration of treatment was 5.2 months and 15% of the patients remain on therapy. Median progression-free survival (PFS) was 3.2 months (IQR 2.9-4.6) and median overall survival (OS) was 69% (IQR 66-73%). Patients with >=3 TRAE had longer PFS. Objective response rate (ORR) was 20.8% (IQR 1.2-19.6%). Stable disease was seen in 31.6% and disease progression in 47.6%. The adverse events are listed in the table below. Treatment discontinuation due to any grade TRAE occurred in 54 patients (7.5%).
In conclusion, NIVOREN GETUG AFU 26 is the largest prospective “real-world setting” study of nivolumab in mRCC, and demonstrates that safety and efficacy are similar to the initial pivotal study. Interestingly, patients who had >=3 TRAE also had longer PFS which deserves further investigation.
Presented by: Laurence Albiges, MD, PhD, Head, Genitourinary Unit, Gustave Roussy Institute, Villejuif, France
Written by: Selma Masic, MD, Urologic Oncology Fellow (SUO), Fox Chase Cancer Center, @selmasic at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium, (ASCO GU) #GU19, February 14-16, 2019 - San Francisco, CA