286 Background: RCC accounts for ~80%‒90% of all kidney cancers worldwide. The mRCC treatment landscape is rapidly changing with the approval of new therapies; data describing real-world (RW) treatment patterns and sequencing are limited. This study investigates the characteristics, treatment patterns, and sequencing for mRCC patients in the RW (December 2015‒May 2020) and post-dual immuno-oncology therapy (IO-IO) approval in the United States (April 2018‒May 2020). Methods: Adults diagnosed with mRCC between December 2015 and May 2020 were selected from the Flatiron electronic medical record database for this retrospective study. The study cohort was required to have ≥ 1 month of medical data from the initial mRCC diagnosis date (index date). We used descriptive statistics to analyze baseline patient characteristics, treatment patterns, and sequencing. Results: Of 3,524 patients with mRCC (overall cohort, December 2015–May 2020), most were male (68.5%) and had clear cell histology (68.2%). The median age at metastatic diagnosis was 68 years (range, 23–85) and the median follow-up from index date was 328 days. Based on IMDC risk score, 75.8% of patients were categorized as intermediate/poor risk and 23.2% as favorable risk (1% missing). Systemic therapy for RCC was initiated in 79.1% (N = 2788) of patients. The most common treatments for first-line (1L) therapy were tyrosine kinase inhibitor (TKI) monotherapy (mono; 56.4%), IO-IO (19.1%), IO-TKI (9.5%), IO mono (6.9%), and others (8.1%). Second-line (2L) therapy was received by 1303 patients; treatment sequences are presented in the table below. Among patients who received IO-based therapy in the 1L (N = 990), 11% were retreated with IO on any subsequent line. When stratified by clear cell and non-clear cell histology, similar treatment patterns and sequences were observed. Among patients who initiated 1L treatment post-April 2018 (N = 1395), the most common treatments for 1L therapy were IO-IO (36.9%) and TKI mono (32.7%). Among patients who received 2L treatment after initiating 1L post-April 2018 (N = 486), TKI mono followed by IO mono, and IO-IO followed by TKI mono were the most prescribed sequences (Table). Conclusions: Following approval of IO-based therapies for 1L, RW treatment patterns for mRCC are evolving; IO-IO has become the most common 1L therapy received by all patients initiating treatment for mRCC. [Table: see text]

288 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. [Table: see text]

Background: Second-line (2L) treatment options for advanced renal cell carcinoma (aRCC) include the tyrosine kinase inhibitors (TKI) cabozantinib and axitinib. We characterized real-world (RW) use of cabozantinib (most recently approved TKI) and axitinib (most commonly used 2L TKI) for aRCC in England.Methods: This was a retrospective cohort study using the Cancer Analysis System (CAS). Patients were 18 yrs, had renal cell carcinoma (RCC; ICD-10 code C64 or C65), initiated 2L cabozantinib or axitinib following prior VEGF therapy, had aRCC at diagnosis, or initiated aRCC therapy during the study (Jan 1, 2011eJan 31, 2020). We described treatment patterns and sequences in patients who received 2L cabozantinib (prior axitinib excluded) or axitinib (prior cabozantinib excluded). Duration of therapy (DoT) and overall survival (OS) were also assessed. Inverse probability weighting (IPW) was used to reduce between-cohort differences and compare OS.Results: At study initiation, 77 305 patients in CAS had an RCC diagnosis; 440 were eligible for the cabozantinib cohort, 1045 for the axitinib cohort (median age, 62.5 vs 63.0 yrs; 76.4% vs 70.2% male; 58.6% vs 53.2% aRCC at diagnosis; 18.2% vs 20.4% ECOG PS 0e1). In the cabozantinib cohort, the most common treatment sequences were 1L sunitinib (n ¼ 186) or pazopanib (n ¼ 178) / 2L cabozantinib (n ¼ 377) / 3L nivolumab (n ¼ 68); 7 patients received 3L axitinib. For the axitinib cohort they were 1L pazopanib (n ¼ 500) or sunitinib (n ¼ 422) / 2L axitinib (n ¼ 919) / 3L nivolumab (n ¼ 171) or cabozantinib (n ¼ 49). In the cabozantinib cohort, 27.7% of patients received 3L therapy vs 34.4% in the axitinib cohort. DoT, OS and the IPW OS comparison are shown in the table.Conclusions: This study demonstrates the potential of CAS to generate RW data to complement (and compare vs) randomized controlled trials. There was a signal for prolonged RW OS with 2L cabozantinib (vs axitinib) in patients with aRCC in England who had received prior VEGF therapy.Clinical trial identification: Study number: CLIN-60000-450 j IPN60000.Editorial acknowledgement: Alison Chisholm of Oxford PharmaGenesis, Oxford, UK, provided medical writing and editorial support, which was sponsored by Ipsen.