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314 Background: The combination of axitinib plus pembrolizumab (AXI+PEM) is a standard of care in the first-line (1L) treatment of patients with advanced clear cell renal cell carcinoma (RCC). This analysis describes the demographic and clinical characteristics, treatment and outcomes of patients receiving 1L AXI+PEM in a real-world setting. Methods: Medical record data were extracted from the Flatiron Health Database, which includes ̃280 cancer clinics across 800 sites in the US. Patients had confirmed Stage IV or metastatic RCC and initiated 1L AXI+PEM on or after 1/1/2018 to 3/31/2021. Tumor response is reported as best overall response to 1L therapy; real-world progression-free survival (rwPFS) and overall survival (rwOS) are reported as patients without a clinical event (rwPFS; progression/death; rwOS; death) at landmark time periods (3, 6, 9, and 12 months); denominators include censored patients. Other data are reported as medians (min, max) unless otherwise noted. Results: Three hundred and fifty-five patients received 1L AXI+PEM, with follow-up of 9.7 (0.1–24.3) months. Most patients were male (69.6%), and age was 68.0 (21.0–84.0) years. At diagnosis, 55.5% of patients had Stage IV RCC and 77.2% of patients had clear cell histology. IMDC Risk Score was favorable, intermediate, and poor in 27 (7.6%), 126 (35.5%), and 76 (24.4%) patients, respectively. At the time of analysis, 270 patients (76.1%) received only 1L therapy with AXI+PEM, while 85 patients (24.3%) received ≥1 subsequent line of treatment. VEGF-R inhibitors were the most commonly used second-line (2L) treatment (51 patients, 60.0%), with cabozantinib as the most frequently used VEGF-R inhibitor (40 patients, 47.1%). rwPFS at 3 months and 1 year was achieved by 248 patients (69.9%) and 77 patients (21.7%), respectively. rwOS ranged from 293 patients (82.5%) surviving at 3 months to 142 patients (40.0%) surviving at 1 year. Best overall response rate to 1L was 47.9% (complete or partial response observed in 170/355 patients). Conclusions: This study provides real-world evidence for the use and effectiveness of 1L AXI+PEM in patients with advanced RCC. AXI+PEM was used across all IMDC risk groups. While these initial finding support the use of AXI+PEM, additional follow-up is warranted to provide further understanding of the clinical outcomes and treatment patterns of patients with advanced RCC in the US receiving 1L AXI+PEM.

636 Background: It is unclear whether post-nephrectomy patients with renal cell carcinoma (RCC) in real-world practice settings are typically assessed for recurrence risk post-operatively and whether patients at high risk of recurrence are seen by providers who can evaluate candidacy for adjuvant systemic therapy (AST), clinical trials, or alternative surveillance schedules. Methods: We identified all patients with locoregional RCC who underwent nephrectomy within Duke University Health System between April 1, 2015 and March 31, 2019 via an institutional database. Medical records were reviewed to identify patient characteristics, post-nephrectomy treatment and referrals, and follow up. Patients with tumor stage 3 or higher and tumor grade 2 or higher, regional lymph-node metastasis, or both, were classified as high risk of recurrence. Results: Of 500 patients with locoregional RCC who underwent nephrectomy, 111 (22.2%) had high risk of recurrence (Table). 15 patients with high risk disease (13.5%) were referred to a medical oncologist for discussion of AST. Fourteen of the 15 referrals took place in 2018 or later. 7 of 29 (24.1%) high risk patients were referred for discussion of AST in 2018 and 7 of 9 (77.8%) in 2019. All referrals were made by urologists to medical oncologists. Two patients received AST – one as part of a clinical trial and one node-positive patient received standard-of-care sunitinib. In the cohort of high-risk patients, follow up data was available for 83 patients with median follow up time of 1.16 years; 31 patients (37.4%) developed recurrent disease. Conclusions: Within a single large academic institution, despite increasing numbers of patients with locoregional RCC at high risk of recurrence being referred to medical oncologists after nephrectomy, few patients received AST. These findings highlight the need for continued efforts at identifying effective AST and referring patients most likely to benefit.[Table: see text]

643 Background: In 2019, there was an estimated 73,820 new cases of kidney cancers in the US. The tx landscape for aRCC is changing rapidly. Recently approved txs for 1L aRCC include new targeted agents and immuno-oncology (IO) therapies. We examine outcomes for pts who completed 1L tx. Methods: Real-world data were drawn from the RCC Disease Specific Programme; a cross-sectional survey administered to US oncologists, nephrologists and urologists. Physicians completed pt record forms (PRFs) for up to the next 8 consulting aRCC pts receiving drug tx, from February - September 2019, plus additional optional PRFs for pts receiving/who had received either 1L tx of nivolumab/ipilimumab combination or cabozantinib, where these pts were available. Results: Physicians (n=82) provided data on 687 pts; 230 had progressed from 1L tx and were on 2L tx at time of data collection. Of those receiving 2L tx, 61% male; mean age was 66.4 years (SD=11.0); 43% stage IV at diagnosis. At 1L, 72% (n=165) had received tyrosine kinase inhibitor (TKI) monotherapy; 16% (n=37) IO+IO, 3% (n=7) TKI+IO and 9% (n=20) other regimens. Mean 1L duration was 10.3 months (SD=9.4) and mean time to 2L initiation was 13.7 months (SD=21.1). 1L treatment responses were: 6% complete response, 21% partial response, 16% stable disease, and the remainder relapsed/progressed (44%) or unknown response (13%). Most common 2L regimens were TKI (37%) or IO (34%) monotherapy. 47% of 1L TKI monotherapy pts received 2L IO monotherapy. 86% of 1L IO+IO pts received 2L TKI monotherapy. Conclusions: Some pts with aRCC progress to 2L; many experience poor clinical outcomes with 1L txs, highlighting high unmet need in 1L for more efficacious txs. Optimal tx strategy (and sequencing) continues to evolve. Approval of IO+TKI therapies, approved during the fieldwork period, has broadened the therapeutic landscape for 1L aRCC. Whilst the proportion of 1L pts receiving IO+TKI therapies is still low, the adoption of these in 1L is likely to transform the management of aRCC. Further research is needed to determine the optimum tx sequence in these pts with high unmet need.

610 Background: Prognostic factors such as the IMDC criteria have included all types of targeted therapy. This study assesses clinical outcomes and provide benchmarks for mRCC pts treated specifically with 1L SUN in the real world to provide contemporary benchmarks for outcomes and survival. Methods: Clear cell mRCC pts initiating SUN as 1L therapy between 2010-2018 were included in a retrospective database study. Kaplan Meier analysis was used to estimate median time to treatment discontinuation (TTD) and overall survival (OS: time to death) by IMDC risk groups based on Karnofsky Performance Status < 80%, diagnosis to treatment interval < 1 year, anemia, neutrophilia, hypercalcemia and thrombocytosis. Results: Among 1,769 1L SUN pts with clear cell in the RW clinical database, 318 (18%) had favorable, 1,031 (58%) had intermediate and 420 (24%) had poor IMDC risk. Across the favorable, intermediate, and poor risk groups, pts had similar mean age in years, gender distribution, and year of SUN initiation (age: 63.8, 62.9 and 62.6; male: 74%, 75%, and 72%; SUN initiation year of 2010-2013: all 71%). In the favorable risk group, 99% received nephrectomy vs 88% in intermediate and 66% in poor risk group. Median TTD was 15.0, 8.5, and 4.2 months (mos) in the favorable, intermediate, and poor risk groups, respectively, and was 7.1 mos in the combined intermediate/poor risk groups. Median OS was 52.1, 31.5, and 9.8 mos in the favorable, intermediate, and poor risk groups, respectively, and was 23.2 mos in the combined intermediate/poor risk groups. Conclusions: This real world study based on a contemporary cohort of 1L SUN mRCC pts found a median OS of 52 mos which sets a new benchmark for clear cell mRCC in the favorable risk group. OS in the intermediate and poor risk groups are similar to previous reports. This affects pt counselling and clinical trial design.

e17526 Background: Human papillomavirus (HPV) is one of the main risk factors associated with squamous cell carcinoma of the head and neck (SCCHN). Although it is a prognostic factor, SCCHN patients are not routinely tested for HPV status because it may not be informative for therapy initiation. The objective of this study was to understand the real world testing patterns, and treatment decision of SCCHN patients. Methods: Real world data was gathered using Adelphi’s Disease-Specific Programme (DSP) - a real world, cross-sectional survey conducted in the USA, France, Germany and the UK (April - September 2016). The DSP incorporated 182 physician interviews (54 US, 128 EU) covering all stages of SCCHN caseloads and treatment patterns. Physicians also provided data for 8 consecutive consulting SCCHN patients regarding treatment patterns, progression, and symptoms. Results: A total of 2193 SCCHN patient cases were captured. HPV testing was carried out in 42% of patients within the DSP data set with no particular difference across the 4 countries. Of those tested, 35% of patients were HPV positive. Testing was mainly performed at the local level (51%, onsite or local hospital) apart from Germany where central testing was higher (73%). In over half of patients cases (54%) , physicians are unaware of the type of test performed for the HPV status determination; in fact, up to 10 different types of tests were used to determine the HPV status in this real world experience. Platinum based cetuximab and fluorouracil was used in 30% of the HPV positive patients while 20% received platinum monotherapy. In 2nd line, docetaxel/paclitaxel monotherapy was used in 22% of the patients. HPV negative patients also mainly received platinum based cetuximab and fluorouracil (27%) in 1st line, while in 2ndline, docetaxel/paclitaxel monotherapy was used in 20% of the patients. Conclusions: This analysis of real world treatment patterns and outcomes among SCCHN patients shows that HPV testing is not widely carried out for either patient characterization or to guide treatment decisions within this disease. Therapy choices were generally consistent standard clinical guidelines.