San Francisco, CA (UroToday.com) Robert Motzer, MD presented the final results of the CheckMate025 study. Previously, the study had demonstrated superior overall survival in patients with previously treated advanced renal cell carcinoma. Additionally, as compared to everolimus, patients receiving nivolumab experienced an improved safety and tolerability profile. These results ushered in a new era of treatment, widening the armamentarium against advance RCC.
In his presentation, Dr. Motzer shared the final analysis of the trial with an extended minimum follow-up of 64 months. As previously described patients were randomized to either nivolumab vs everolimus. The primary end point was overall survival, while the secondary endpoints included objective response rate (ORR), progression-free survival (PFS), and safety. Confirmed ORR and PFS were per investigator using RECIST. The primary analysis was performed after a minimum of 14 months and was published in 2015.
Overall, 410 vs 411 pts were randomized to nivolumab or everolimus, respectively. At the prolonged follow-up, overall survival was preserved in the nivolumab arm. As for progression free survival, patients receiving nivolumab had a decreased risk of progression (HR 0.84 (95% CI 0.72–0.99).
Additionally, those in the nivolumab experienced a higher overall response rate (23% vs 4%) and a longer median duration of response (18.2 vs 14.0 months) compared to those in the everolimus arm. Despite a robust initial response, most patients received subsequent lines of therapy regardless of arm, 67% in the nivolumab arm v s 72% in the everolimus arm. No new safety signals or treatment-related deaths emerged with long-term follow-up in either arm. As previously reported more pts in the everolimus arm (37%) experienced a grade 3/4 treatment-related AE compared to 21% in the nivolumab arm.
In concluding his talk, Dr. Motzer highlighted the overall benefits realized by those receiving nivolumab monotherapy even with prolonged follow-up. As we continue to move forward with immunotherapy in the treatment of RCC, this study will remain a key part of its foundation.
Clinical trial information: NCT01668784
Presented by: Robert J. Motzer, MD Memorial Sloane Kettering Cancer Center, New York, NY
Written by: Adrien Bernstein, MD, Society of Urologic Oncology Fellow, Fox Chase Cancer Center, Fox Chase Cancer Center, Philadelphia, PA at the 2020 Genitourinary Cancers Symposium, ASCO GU #GU20, February 13-15, 2020, San Francisco, California