ASCO GU 2019: Treatment-Free Survival after Discontinuation of First-Line Nivolumab Plus Ipilimumab or Sunitinib in Intention-to-Treat and IMDC Favorable-Risk Patients with Advanced Renal Cell Carcinoma from CheckMate 214

San Francisco, CA (UroToday.com) Treatment with immune-oncology (IO) agents can result in periods of disease control without the need for subsequent systemic therapy in multiple urologic malignancies.  Because of this finding, new endpoints that characterize IO treatment response are needed to adequately characterize antitumor response.  At the Renal Cell Carcinoma poster session at the 2019 Genitourinary Cancers Symposium, Dr. David McDermott from Beth Israel Deaconess Medical Center in Boston, MA, discussed the concept of treatment-free survival (TFS) in patients after discontinuation of combination nivolumab plus ipilimumab or sunitinib in favorable-risk patients with advanced renal cell carcinoma (RCC).  This project was a post-hoc subset analysis of favorable-risk patients from the CheckMate 214 study.

In this study, patients with previously untreated advanced clear cell RCC were randomized 1:1 to receive either intravenous nivolumab and ipilimumab in combination every 3 weeks for 4 doses, followed by nivolumab alone every two weeks, or sunitinib daily for 4 weeks on treatment and 2 weeks off treatment (6-week cycles). Minimum follow-up for this study was 30 months.  McDermott and his group found that in the intent to treat population time from randomization to subsequent systemic therapy or death was significantly longer with nivolumab plus ipilimumab (18.5 months) versus sunitinib (10.5 months) for all patients.  When stratified by favorable risk status, patients receiving combination nivolumab plus ipilimumab had a 26.7-month duration from randomization to subsequent systemic treatment or death, versus 23.2 months with sunitinib. 

McDermott concluded that this study shows that nivolumab + ipilimumab in combination delayed time from randomization to subsequent systemic anticancer therapy or death compared with sunitinib in this patient population.  This significantly longer TFS was present in both the intent to treat group, and the favorable-risk patients, in addition to what had previously been reported in intermediate/poor risk groups.  This study provides further evidence that the durable response supports the superior risk/benefit profile and value of nivolumab + ipilimumab over sunitinib in patients with previously untreated advanced renal cell carcinoma. 

Presented by: David McDermott, MD Beth Israel Deaconess Medical Center in Boston, Massachusetts

Written by: Brian Kadow, MD. Society of Urologic Oncology Fellow, Fox Chase Cancer Center at the Annual ASCO GU meeting 2019, San Francisco, CA, Twitter: @shekabhishek at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium, (ASCO GU) #GU19, February 14-16, 2019 - San Francisco, CA