1896P - Clinical management and outcomes of patients with advanced renal cell carcinoma (aRCC) treated with nivolumab+ipilimumab (N+I): A real-world study

Background

N+I is approved for the first-line (1L) treatment of adult patients with intermediate/poor-risk aRCC, with efficacy demonstrated in CheckMate 214. Real-world effectiveness (RWE) data are limited; we assessed clinical characteristics and outcomes for aRCC patients who received N+I in England.

Methods

This retrospective, observational chart review examined patient demographics, clinical characteristics, treatment patterns, safety and outcomes (objective response [OR], progression-free survival [PFS], overall survival [OS]) of patients with aRCC treated with N+I at five sites in England. Eligible patients-initiated N+I at any line of therapy from 5-Apr-19 to 1-Apr-22 (including during COVID lockdown periods) and were followed until death or study end.

Results

128 patients met eligibility criteria (mean age 60.7 yr, 71.1% male); 85.2% had clear cell histology; most had intermediate or poor IMDC classification at index (49.2% and 39.1%, respectively). Median follow-up (min-max) was 13.6 (0.8-37.9) mo. 95.3% (n=122) received 1L N+I. Median time on treatment from 1L initiation was 2.8 (0.03-34.4) mo and 54.1% (n=66) advanced to 2L therapy, mostly (n=56, 77.8%) to cabozantinib. Overall, 82% discontinued 1L therapy; most frequently for disease progression (n=23; 50.5%) or AEs (n=40; 38.1%). In patients receiving 1L N+I, OR was 29.7%, with a complete response rate of 1.1%; median PFS from 1L initiation was 7.6 mo; 1-yr PFS was 40.3% and 1-yr OS was 71.4%.

Conclusions

This study provided RWE on the characteristics and outcomes of patients with aRCC who received N+I. OR, PFS and OS were slightly inferior to those observed in CheckMate 214 but comprised a real-world population with a higher proportion of poor risk patients, those with CNS metastases, non-clear cell histology and treatment during the COVID pandemic.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

BMS.

Funding

BMS.

Disclosure

L.M. Pickering: Financial Interests, Institutional, Research Grant: NIHR, Rosetrees Trust; Financial Interests, Personal, Speaker, Consultant, Advisor: BMS, Eisai, MSD, Novartis, Pfizer; Financial Interests, Institutional, Other: Kidney and melanoma cancer fund of RMH charity. A. Sharma: Financial Interests, Personal, Advisory Board: BMS, MSD, Eisai, EUSA, Pfizer; Financial Interests, Personal, Other: Ipsen, EUSA, Pfizer, Ferring; Financial Interests, Personal, Invited Speaker: BMS, Ipsen, Chugai, Novartis, EUSA, Pfizer, Merck, Janssen. P. Dhokia: Financial Interests, Personal, Full or part-time Employment: BMS; Financial Interests, Personal, Other: BMS; Financial Interests, Personal, Stocks/Shares: BMS. M. Hale: Financial Interests, Institutional, Funding, Employee of HEOR who received funding from BMS for conducting the study: BMS. All other authors have declared no conflicts of interest.