Treatment sequence after first-line nivolumab plus ipilimumab or sunitinib monotherapy in patients with metastatic renal cell carcinoma (mRCC) using real-world data.

Authors

Daniel Geynisman

Daniel M. Geynisman

Fox Chase Cancer Center, Philadelphia, PA

Daniel M. Geynisman , Jillian Faccone , Ying Zhang , Flavia Ejzykowicz , Brian Stwalley , Melissa Hamilton , Trong Kim Le , Stephen Huo

Organizations

Fox Chase Cancer Center, Philadelphia, PA, Bristol Myers Squibb, Princeton, NJ

Research Funding

Pharmaceutical/Biotech Company
Bristol Myers Squibb.

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.

Selected 2L and 3L therapies, showing top 2 by frequency for each 1L therapy.

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)
CABO33 (50.0)8 (6.7)28 (50.9)4 (4.3)5 (45.5)4 (15.4)
PAZO8 (12.1)10 (8.4)6 (10.9)6 (6.5)2 (18.2)4 (15.4)
NIVO1 (1.5)58 (48.7)046 (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)
AXI4 (18.2)5 (8.3)2 (10.5)3 (6.5)2 (66.7)2 (15.4)
EVE+LEN4 (18.2)5 (8.3)4 (21.1)5 (10.9)00
CABO2 (9.1)16 (26.7)2 (10.5)13 (28.3)03 (23.1)
NIVO1 (4.5)9 (15.0)1 (5.3)7 (15.2)02 (15.4)

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Abstract Details

Meeting

2021 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session: Renal Cell Cancer

Track

Renal Cell Cancer

Sub Track

Patient-Reported Outcomes and Real-World Evidence

Citation

J Clin Oncol 39, 2021 (suppl 6; abstr 288)

DOI

10.1200/JCO.2021.39.6_suppl.288

Abstract #

288

Poster Bd #

Online Only

Abstract Disclosures