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Introduction: Clinical availability of highly effective novel agents (including Bruton tyrosine kinase [BTK] and B-cell lymphoma 2 [BCL-2] inhibitors) is rapidly altering the therapeutic landscape of chronic lymphocytic leukemia (CLL) necessitating a review of treatment guidelines. However, there is limited real-world data to validate if the availability of these novel agents has translated to a true shift in treatment paradigm for patients treated in the community. As the majority of CLL patients are treated in non-academic community-based settings, we investigated the clinical adoption trends of commercially available FDA approved novel agents for treatment of CLL patients. In addition, given that the COVID-19 pandemic led to major alteration in clinical oncology practices, we further studied if this contributed to an alteration in the selection of therapeutic agents resulting in changes of CLL treatment patterns and the utilization of novel agents in the real-world setting. Thus, the objectives of this study were to examine the utilization pattern of various CLL therapies, as well as evaluate the pattern of adoption of novel agents for treatment and the impact of COVID. Methods: A retrospective observational study was conducted using the Flatiron Health database that comprised EHR-derived de-identified data. Adult patients (≥18 years) with newly diagnosed CLL from January 2014 to May 2021, with no prior treatment and who were continuously enrolled for at least 6 months before and 3 months after the index date, defined as the first date of CLL/SLL diagnosis were included. Treatment regimens were classified into seven mutually exclusive categories: bendamustine-based chemotherapy, other chemotherapy, anti-CD20-based therapy, ibrutinib, idelalisib, acalabrutinib and venetoclax. Further treatment categorization included chemotherapy vs. targeted therapy, and traditional IV vs. novel oral agents. The impact of the pandemic was examined by comparing the pre- and post-COVID cohorts (defined as 15 months pre- and post- of March 1, 2021). Descriptive analyses were conducted to examine the frequency of use of treatment regimens by quarter in each year, line of therapy and between different age, gender, US geographical region, insurance status, and race/ethnicity subgroups. Multivariable regression was conducted to examine factors associated with the likelihood of adoption of novel and oral agents. Statistical significance was determined at a p-value of less than 0.05. Results: A total of 3,037 newly diagnosed CLL patients (median age =73) were included in the study. Over half were male (62.3%), white (74.6%) and commercially-insured (54.1%). Patients were primarily treated in community practices (92%). Overall, a significant trend in adoption of novel agents was observed throughout the years following their approval (Figure 1A). Across the evaluation period, a significant decrease in chemotherapy use was observed from 61.3% (quarter 1, 2014) to 20% (quarter 2, 2021) in favor of targeted therapy as first-line therapy (Figure 1B). In contrast, the utilization of novel oral agents (vs. traditional IV agents) for first-line therapy increased from 9.5% to 70.9% for the same period (Figure 1C). Similar trends were observed for second-line and third-line therapies. Encouragingly, this change in treatment patterns was adopted comparably in all sociodemographic subgroups with no evidence of disparity. While there was no statistically significant difference between the pre- and post-COVID treatment landscape, the adoption of target and novel oral agents has been more pronounced with the COVID pandemic. Conclusions: Results from real-world data suggest that there is a clear shift towards the adoption of novel therapies with preference given to targeted agents and oral therapies in the US since 2014. Further research examining real-world outcomes associated with treatment regimens are needed to inform decision makers. Figure 1 Figure 1. Disclosures Chanan-Khan: Cellectar: Current equity holder in publicly-traded company; Alpha2 Pharmaceuticals, NonoDev, Starton: Current holder of stock options in a privately-held company; Ascentage: Research Funding; Alpha2 Pharmaceuticals: Patents & Royalties: Tabi; Ascentage, Starton, Cellectar, NonoDev, Alpha2 Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; BeiGene, Jansen, Ascentage: Honoraria; BieGene, Jansen, Ascentage: Consultancy. Yang: BeiGene, Ltd.: Current Employment. Liu: BeiGene, Ltd.: Current Employment. Zimmerman: BeiGene, Ltd.: Current Employment. Tang: BeiGene, Ltd.: Current Employment. Ailawadhi: Karyopharm: Consultancy; AbbVie: Consultancy; Genentech: Consultancy; Takeda: Consultancy; GSK: Consultancy, Research Funding; Xencor: Research Funding; Cellectar: Research Funding; Medimmune: Research Funding; Ascentage: Research Funding; Pharmacyclics: Consultancy, Research Funding; Amgen: Consultancy, Research Funding; Janssen: Consultancy, Research Funding; Bristol Myers Squibb: Consultancy, Research Funding; BeiGene, Ltd.: Consultancy; Sanofi: Consultancy; Oncopeptides: Consultancy.

Introduction: Myelodysplastic syndromes (MDS) are a group of progressive clonal hematopoietic malignancies that primarily affect an elderly demographic. MDS is treated based on age, symptoms, disease severity, and prognostic scoring. There is limited evidence on the health economic burden and how transfusion dependency affects clinical outcomes of patients with MDS in Japan. This is the first retrospective database analysis study that was performed to elucidate the patient baseline characteristics, 1-year medical costs, and 3-year overall survival (OS) in patients treated for MDS using an administrative claims database of more than 150 hospitals in Japan. Methods: In this study, we used the Medical Data Vision (MDV) database to identify patients diagnosed with MDS (International Classification of Diseases, Tenth Revision, [ICD-10]: code D46.9) using a nationwide administrative database comprising anonymized data covering more than 25 million patients. Patients who received transfusions, erythropoiesis-stimulating agents (ESA) with or without transfusions, azacitidine (AZA) with or without transfusions, and other (e.g. chemotherapy such as doxorubicin, cytarabine) as the index treatment during the identification period from October 1, 2009 to June 30, 2018 were included if they had 1 year of lookback data before the index date and a follow-up period of ≥ 1 year. Results: Of the 5,981 patients with MDS who met the eligibility criteria for this study, 37.8% were female; the median age of patients was > 70 years. Patients receiving transfusion in their index line of therapy was the largest regimen group (n = 2,844, 47.6%), followed by AZA + transfusion (n = 703, 11.8%), ESA (n = 294, 4.9%), and AZA (n = 288, 4.8%). The AZA regimen had the youngest mean age of 70.2 years while the ESA + transfusion group had the oldest (77.8 years). AZA and AZA + transfusion groups recorded a median Charlson Comorbidity Index score of 1.9 and 2.0, respectively, whereas ESA and ESA + transfusion groups had a mean score of 3.2 and 2.6, respectively. Medical costs varied widely for these groups (Figure 1). Mean overall costs were highest for the AZA + transfusion regimen group (USD 63,226) and lowest for the ESA group (USD 15,931). Mean overall costs for regimen groups without transfusion were highest for AZA (USD 47,475), followed by ESA (USD 15,931; P < 0.0001), and the addition of the transfusion component was observed to incur higher overall costs, inpatient costs, and MDS-related treatment costs. Inpatient costs for the ESA groups ranged from USD 16,717 for ESA only to USD 30,347 for ESA + transfusion. The highest outpatient costs were observed for the AZA group (USD 20,011; P < 0.0001). MDS-related treatment costs were highest for the AZA + transfusion group (USD 32,123) and lowest for the ESA group (USD 2,518; P < 0.0001). Overall, there were 1,966 deaths (32.9%) recorded within 3 years of index treatment. The median OS for patients receiving AZA + transfusion was 957 days (Figure 2). Conclusions: In this study, mean overall costs, inpatient costs, and outpatient costs were highest for the AZA + transfusion regimen group. Consistent with the trend of MDS studies, the majority of patients with MDS received supportive transfusion-dependent therapy. Transfusion dependency led to considerable incremental cost and poorer clinical outcomes compared with other regimens. This study provides insights into the real-world disease burden for patients with MDS and the current treatment options available for MDS in Japan. Disclosures Tsutsué: Celgene KK, a Bristol-Myers Squibb Company: Current Employment. Suzuki:Bristol Myers Squibb: Honoraria; Nippon Shinyaku Co., Ltd: Honoraria; Kyowa Hakka Kirin Co., Ltd: Honoraria, Research Funding; Novartis Pharmaceuticals: Honoraria. Kim:Syneos Health: Current Employment. Kuan:Syneos Health Clinical K.K.: Current Employment. Crawford:Syneos Health: Current Employment.

Introduction: Follicular lymphoma (FL) is an indolent form of non-Hodgkin lymphoma (NHL), which accounts for 20-30% of all NHL cases. In most patients, FL is diagnosed in advance stages, mild disease progression and long treatment period that may incur a great burden to patients and healthcare system. However, to our knowledge there is no comprehensive analysis which have been done in the real world setting in Japan. Therefore, we conducted a retrospective claim database study to elucidate the lines of treatment patterns as well as the associated healthcare resource utilization (HCRU), and 3- and 5-year overall survival (OS) among 3,593 Japanese patients with a median age of 65.0 years. Methods: This retrospective study analyzed data from the Medical Data Vision (MDV) database for patients diagnosed with FL (ICD-10: C82). The MDV database is an electronic health records-based database comprised of anonymized inpatient and outpatient data covering over 25 million patients and over 374 Japanese hospitals, approximately 22% of acute phase hospitals, including 187 cancer therapeutic facilities. Patients who received treatment during the identification period from 1 October 2008 to 31 December 2017 were selected. Patients were required to have data for at least 6 months before the first treatment date (ie, patient index date) and at least 12 months after the index date (unless they died). Costs were converted from Japanese yen to US dollars using the exchange rate based on January of each year of service. For 3- and 5-year OS, patients who had a record of death in their hospital discharge were counted as an event, otherwise they were censored at the latest of: end of patient record, end of data availability, or end of the 3- or 5- year period. Results: A total of 3,593 patients with FL met the inclusion criteria of which 51.2% was female patients. Of these 3,593 patients who met the inclusion criteria, 3,004 patients (83.6%) received rituximab-based (R) therapy as index treatment, of which 1309 (36.4%) of patients received R-CHOP. During the subsequent lines of therapies, patients received heterogeneous treatment regimens (fig 1). Overall, the average healthcare cost during follow-up period was $67,557.40 for all FL patients, ranging from $39,340 (immunotherapy, targeted therapy, or hormone therapy without R) to $ 95,095 (other R-based chemotherapy). The average number of outpatient visits during follow-up for all FL patients was 51, ranging from 44.6 to 55.1 for each treatment group. There were 3,394 (94.5%) patients who had at least one hospitalization during follow up period. Among those who had at least one hospitalization, the average number of hospitalizations was 3.8 for all FL patients, ranging from 2.5 to 4.6 for each treatment group. The average number of days of hospitalization during follow-up was 74.5 for all FL patients, ranging from 31 to 110.4 for each treatment group. 85 (2.4%) FL patients received a stem cell transplant (SCT) during follow-up at the age under 79 years, with other R-based therapies having the highest percentage (7.6%). There were 346 (9.7%) FL patients receiving radiation therapy, ranging from 8.1% (other treatment groups) to 24.1% (immunotherapy, targeted therapy, or hormone therapy without R). There were 337 deaths (9.4%) recorded within 3 years and 400 (11.1%) within 5 years of index treatment. The median Kaplan-Meier OS was not reached for most analysis groups due to the overall high survival rates. When comparing overall survival by index regimen group, chemotherapy without R consistently had worse survival, especially compared to R-based regimens (fig. 2). Conclusions: Patients with FL in Japan received diverse treatment regimens and multiple lines of therapy with relatively high survival rates. Majority of patients have received R-based therapies and have shown longer survival rates compared to those who have received chemotherapy without R. This is the first study to clarify lines of treatment patterns using retrospective claims database and treatment group-based OS in FL patients in Japan, which will give clinical insights of the landscape of daily practices and the associated real world health economic burden for patients, clinicians and healthcare providers to support their better decision makings. Disclosures Tsutsue: Celgene: Employment. Tobinai:Solasia: Honoraria; Mundi Pharma: Consultancy, Honoraria, Research Funding; Takeda Pharmaceutical: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Ono Pharmaceutical: Consultancy, Honoraria, Research Funding; Yakult: Honoraria; AbbVie: Research Funding; Meiji Seika: Honoraria; Janssen Pharmaceutical: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria; HUYA Bioscience: Consultancy, Honoraria; Zenyaku Kogyo: Consultancy, Honoraria; Daiichi Sankyo: Consultancy, Honoraria; Eisai: Honoraria, Research Funding; Chugai Pharmaceutical: Honoraria, Research Funding; Verastem: Honoraria; Kyowa Kirin: Honoraria, Research Funding. Yi:Celgene: Consultancy. Crawford:Celgene: Consultancy.