Fox Chase Cancer Center, Philadelphia, PA
Daniel M. Geynisman , Jillian Faccone , Ying Zhang , Flavia Ejzykowicz , Brian Stwalley , Melissa Hamilton , Trong Kim Le , Stephen Huo
Background: The introduction of second-line (2L) nivolumab (NIVO) in 2015 (CheckMate 025) and first-line (1L) NIVO plus ipilimumab (NIVO+IPI) in 2018 (CheckMate 214) revolutionized the management of mRCC in the US. This study sought to leverage real-world (RW) data by applying CheckMate 214 inclusion criteria to develop a RW comparator for the trial to assess treatment patterns and sequences in RW patients (pts) with mRCC after receiving 1L NIVO+IPI or sunitinib (SUN). Methods: This retrospective study identified pts with clear cell mRCC from the Flatiron Health EHR-derived de-identified database who received 1L NIVO+IPI or SUN monotherapy on or after December 2015. Pts must have met the strict selection criteria from CheckMate 214 for this analysis. Evaluation of 1L, 2L, and third-line (3L) therapies was stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk (favorable [FAV] and intermediate/poor [I/P]). Results: Of 401 mRCC pts included in the study, 197 (49.1%) received NIVO+IPI and 204 (50.9%) received SUN as 1L therapy (Table). The median follow-up time was 10.1 months in NIVO+IPI pts and 20.2 months in SUN pts (P< 0.0001). Among 66 (33.5%) NIVO+IPI pts who received 2L line therapy, the 2 most common therapies were cabozantinib (CABO; 50.0%), and pazopanib (PAZO; 12.1%). Among 119 (58.3%) SUN pts who received 2L therapy, the most common therapies were NIVO (48.7%), and PAZO (8.4%). The 2 most common 3L therapies were axitinib (AXI; 18.2%) or everolimus plus lenvatinib (EVE+LEN; 18.2%) for NIVO+IPI pts, and CABO (26.7%) or NIVO (15.0%) for SUN pts. The treatment sequence is similar between patients with FAV and I/P risk. Conclusions: In the RW setting, the treatment sequences after NIVO+IPI and SUN were largely similar across the IMDC risk groups. CABO was the most common therapy in 2L after NIVO+IPI in RW pts, and NIVO was the most common 2L therapy after SUN monotherapy, which was consistent with the sequence in the trial.
All pts: 1L NIVO+IPI (N = 197) | All pts: 1L SUN (N = 204) | I/P risk: 1L NIVO+IPI (N = 164) | I/P risk: 1L SUN (N = 154) | FAV risk: 1L NIVO+IPI (N = 33) | FAV risk: 1L SUN (N = 48) | |
---|---|---|---|---|---|---|
Pts with 2L therapy, n (%) | 66 (33.5) | 119 (58.3) | 55 (33.5) | 92 (59.7) | 11 (33.3) | 26 (54.2) |
CABO | 33 (50.0) | 8 (6.7) | 28 (50.9) | 4 (4.3) | 5 (45.5) | 4 (15.4) |
PAZO | 8 (12.1) | 10 (8.4) | 6 (10.9) | 6 (6.5) | 2 (18.2) | 4 (15.4) |
NIVO | 1 (1.5) | 58 (48.7) | 0 | 46 (50.0) | 1 (9.1) | 11 (42.3) |
Pts with 3L therapy, n (%) | 22 (11.2) | 60 (29.4) | 19 (11.6) | 46 (29.9) | 3 (9.1) | 13 (27.1) |
AXI | 4 (18.2) | 5 (8.3) | 2 (10.5) | 3 (6.5) | 2 (66.7) | 2 (15.4) |
EVE+LEN | 4 (18.2) | 5 (8.3) | 4 (21.1) | 5 (10.9) | 0 | 0 |
CABO | 2 (9.1) | 16 (26.7) | 2 (10.5) | 13 (28.3) | 0 | 3 (23.1) |
NIVO | 1 (4.5) | 9 (15.0) | 1 (5.3) | 7 (15.2) | 0 | 2 (15.4) |
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