McKesson Specialty Research Articles

Hematology‐oncology pharmacists: We hear you, we see you, we support you

JACCP: JOURNAL OF THE AMERICAN COLLEGE OF CLINICAL PHARMACYVolume 5, Issue 12 p. 1325-1326 LETTER TO THE EDITOR Hematology-oncology pharmacists: We hear you, we see you, we support you Heidi D. Finnes Pharm.D., Corresponding Author Heidi D. Finnes Pharm.D. [email protected] orcid.org/0000-0002-1117-0983 @@HeidiDiann Mayo Clinic Comprehensive Cancer Center, Rochester, Minnesota, USA Correspondence Heidi D. Finnes, Mayo Clinic, Comprehensive Cancer Center, 200 First Street SW, Rochester, MN 55905-0002, USA. Email: [email protected]Search for more papers by this authorLeAnne Kennedy Pharm.D., LeAnne Kennedy Pharm.D. orcid.org/0000-0001-8989-5469 Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina, USASearch for more papers by this authorLarry W. Buie Pharm.D., FCCP, Larry W. Buie Pharm.D., FCCP Health Systems Liaison, Bristol Myers Squibb, Plainfield, New Jersey, USASearch for more papers by this authorAmber P. Lawson Pharm.D., Amber P. Lawson Pharm.D. UK HealthCare, Lexington, Kentucky, USASearch for more papers by this authorAmy H. Seung Pharm.D., Amy H. Seung Pharm.D. Scientific Affairs, Pharmacy Times, Continuing Education, Cranbury, New Jersey, USASearch for more papers by this authorLisa E. Davis Pharm.D., FCCP, Lisa E. Davis Pharm.D., FCCP orcid.org/0000-0003-1384-1610 R. Ken Coit College of Pharmacy, The University of Arizona, Tucson, Arizona, USASearch for more papers by this authorEmily Mackler Pharm.D., Emily Mackler Pharm.D. orcid.org/0000-0003-1258-1116 Michigan Oncology Quality Consortium and Michigan Institute of Care Management and Transformation, University of Michigan, Ann Arbor, Michigan, USASearch for more papers by this authorAndrea Iannucci Pharm.D., Andrea Iannucci Pharm.D. UC Davis Health, UC Davis School of Medicine, UCSF School of Pharmacy, Sacramento, California, USASearch for more papers by this authorShannon Hough Pharm.D., Shannon Hough Pharm.D. orcid.org/0000-0002-4381-0105 The US Oncology Network, McKesson Specialty Health, The Woodlands, Texas, USASearch for more papers by this author Heidi D. Finnes Pharm.D., Corresponding Author Heidi D. Finnes Pharm.D. [email protected] orcid.org/0000-0002-1117-0983 @@HeidiDiann Mayo Clinic Comprehensive Cancer Center, Rochester, Minnesota, USA Correspondence Heidi D. Finnes, Mayo Clinic, Comprehensive Cancer Center, 200 First Street SW, Rochester, MN 55905-0002, USA. Email: [email protected]Search for more papers by this authorLeAnne Kennedy Pharm.D., LeAnne Kennedy Pharm.D. orcid.org/0000-0001-8989-5469 Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina, USASearch for more papers by this authorLarry W. Buie Pharm.D., FCCP, Larry W. Buie Pharm.D., FCCP Health Systems Liaison, Bristol Myers Squibb, Plainfield, New Jersey, USASearch for more papers by this authorAmber P. Lawson Pharm.D., Amber P. Lawson Pharm.D. UK HealthCare, Lexington, Kentucky, USASearch for more papers by this authorAmy H. Seung Pharm.D., Amy H. Seung Pharm.D. Scientific Affairs, Pharmacy Times, Continuing Education, Cranbury, New Jersey, USASearch for more papers by this authorLisa E. Davis Pharm.D., FCCP, Lisa E. Davis Pharm.D., FCCP orcid.org/0000-0003-1384-1610 R. Ken Coit College of Pharmacy, The University of Arizona, Tucson, Arizona, USASearch for more papers by this authorEmily Mackler Pharm.D., Emily Mackler Pharm.D. orcid.org/0000-0003-1258-1116 Michigan Oncology Quality Consortium and Michigan Institute of Care Management and Transformation, University of Michigan, Ann Arbor, Michigan, USASearch for more papers by this authorAndrea Iannucci Pharm.D., Andrea Iannucci Pharm.D. UC Davis Health, UC Davis School of Medicine, UCSF School of Pharmacy, Sacramento, California, USASearch for more papers by this authorShannon Hough Pharm.D., Shannon Hough Pharm.D. orcid.org/0000-0002-4381-0105 The US Oncology Network, McKesson Specialty Health, The Woodlands, Texas, USASearch for more papers by this author First published: 08 December 2022 https://doi.org/10.1002/jac5.1707Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL No abstract is available for this article. Volume5, Issue12December 2022Pages 1325-1326 RelatedInformation

Completed Induction Phase Analysis of Magnify: Phase 3b Study of Lenalidomide + Rituximab (R 2) Followed By Maintenance in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

Completed Induction Phase Analysis of Magnify: Phase 3b Study of Lenalidomide + Rituximab (R 2) Followed By Maintenance in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

Debulking before Initiation of Venetoclax Therapy in Untreated Patients with Chronic Lymphocytic Leukemia: Results from a Phase 3b Study

Debulking before Initiation of Venetoclax Therapy in Untreated Patients with Chronic Lymphocytic Leukemia: Results from a Phase 3b Study

Efficacy and Safety of Ublituximab in Combination with Umbralisib (U2) in Patients with Chronic Lymphocytic Leukemia (CLL) By Treatment Status: A Sub-Analysis of the Phase 3 Unity-CLL Study

Efficacy and Safety of Ublituximab in Combination with Umbralisib (U2) in Patients with Chronic Lymphocytic Leukemia (CLL) By Treatment Status: A Sub-Analysis of the Phase 3 Unity-CLL Study

Comparable Outcomes With Bortezomib-Cyclophosphamide-Dexamethasone (VCD) and Bortezomib-Lenalidomide-Dexamethasone (VRD) For Initial Treatment Of Newly Diagnosed Multiple Myeloma (MM)

Comparable Outcomes With Bortezomib-Cyclophosphamide-Dexamethasone (VCD) and Bortezomib-Lenalidomide-Dexamethasone (VRD) For Initial Treatment Of Newly Diagnosed Multiple Myeloma (MM)

Tourmaline US-MM6, an Open-Label, Single-Arm, Multicenter Study Evaluating the Effectiveness and Safety of Ixazomib in Combination with Lenalidomide and Dexamethasone (IRd) in Patients (pts) with Newly Diagnosed Multiple Myeloma (NDMM) Switching from a Bortezomib-Based Triplet Induction Regimen

Tourmaline US-MM6, an Open-Label, Single-Arm, Multicenter Study Evaluating the Effectiveness and Safety of Ixazomib in Combination with Lenalidomide and Dexamethasone (IRd) in Patients (pts) with Newly Diagnosed Multiple Myeloma (NDMM) Switching from a Bortezomib-Based Triplet Induction Regimen

Clinical Profiles, Treatment Characteristics and Outcomes Among Newly Diagnosed Hodgkin Lymphoma Patients Presenting with Unfavorable and Advanced Disease within a US Community Oncology Setting

INTRODUCTIONThe intent of treating newly diagnosed Hodgkin lymphoma (HL) patients is to achieve a complete remission that can eventually translate into a cure. Treatment decisions for HL are guided by several factors, including sub-type, stage, disease symptomatology, laboratory results, radiologic imaging, age and overall health. Understanding patient profiles and treatment characteristics is important as there is a demographic difference between patients treated in community and academic settings. The intent of this study was to improve understanding of the HL patient population and treatment trends among unfavorable-/advanced-stage HL patients receiving care within the US community oncology setting. METHODS: This was a retrospective, observational cohort study of adult HL patients with Stage IIB-IV disease who initiated first-line chemotherapy within the US Oncology Network between 1/1/09 - 6/30/12. Patients were followed until 6/30/16. Most data were captured from structured fields of the electronic healthcare record, with a targeted chart review performed to provide additional detail on select study variables for a subset of the study population. Descriptive analyses were performed to assess patient and treatment characteristics, while the Kaplan Meier method was used to calculate the duration of therapy (DOT), time to next treatment (TTNT) and time to stem cell transplantation (SCT). RESULTS: In total, 565 patients met eligibility criteria and were included in the analysis. The mean age of the patient population was 44.3 years (standard deviation [SD] 18.2), 55.0% were male and 69.2% were Caucasian. Most patients (90.4%) received the ABVD regimen (doxorubicin, bleomycin, vinblastine and dacarbazine) or a variant of the ABVD regimen in the first-line setting (LOT1). Seventy-four (13.1%) patients were as assumed to have relapsed/refractory disease, as evidenced by advancement to second-line (LOT2) therapy. Among these patients, 44.6% received an etoposide-containing regimen, 17.6% received a brentuximab vedotin-containing regimen and 9.5% GVD (gemcitabine, vinorelbine, doxorubicin). Nearly 30% of LOT2 patients received a regimen classified into an “other” category because it was received by less than 5 patients in the study. Following LOT1, the median TTNT was 67.9 weeks (95% confidence interval [CI] 50.8,104.5). Among the 511 patients who received ABVD/ABVD variant regimens in LOT1, the median TTNT was 67.9 weeks (95%CI 49.0,90.9). Compared to LOT1, the median DOT of LOT2 was shorter (22.1 weeks [95%CI not reached] vs. 7.6 [95%CI 6.3, 10.1] weeks). The median DOTs of ABVD/ABVD variants and AVD in LOT1 were 22.1 (95%CI not reached) and 20.1 (95%CI 7.1, 22.1) weeks, respectively. Only 32 patients advanced to LOT3 and 7 to LOT4. Among patients selected for chart review, 31.2% reported symptoms associated with peripheral neuropathy during LOT1. Data pertaining to radiologic imaging and SCT were only available among patients selected for chart review. These results indicated that positron emission tomography (PET) scans were most frequently performed at diagnosis (74.9% of records reviewed) and/or after LOT1 (55.3% of records reviewed). At diagnosis, all PET scan results were positive (Deauville score 4-5); after LOT1 71.7% were negative (Deauville score 1-3). Treatment changes explicitly attributed to PET scan results were infrequently documented. Among the 29 patients observed to have undergone SCT, the median time to SCT was 41.1 weeks (95%CI 32.7, 56.8). CONCLUSIONS: These findings provide insight into the patient profiles and treatment progression in a US community oncology setting. In particular, ABVD/ABVD variant regimens were observed to be the predominate therapy in the front-line setting. Intensive salvage therapy and consolidative SCT were uncommon in the second-line setting, with most patients receiving etoposide- and brentuximab vedotin-containing regimens. Utilization of PET imaging at diagnosis, for interim response assessment and at completion of therapy was not universal. The apparent difference in use of imaging observed in this community oncology setting compared to what is reported by academic centers may be due variation treatment practices across these organizations or underlying differences in their patient populations. Future research should explore how patient profiles influence use of imaging and associated treatment decisions. DisclosuresYasenchak:Seattle Genetics: Consultancy; Bristol-Myers Squibb: Consultancy. Feliciano:Seattle Genetics: Employment, Equity Ownership. Aguilar:McKesson Specialty Health: Employment. Clark:McKesson Specialty Health: Employment, Equity Ownership. Amirian:McKesson Specialty Health: Employment. Richhariya:Seattle Genetics: Employment, Equity Ownership.

A Real-World Comparative Analysis of Carfilzomib and Other Systemic Multiple Myeloma Chemotherapies in the US Community Oncology Setting

IntroductionRecently, novel agents have been approved for the treatment of relapsed multiple myeloma (MM). There is a paucity of real-world outcomes data on these novel treatments. The purpose of this retrospective cohort study was to compare time to next treatment (TTNT) between patients who received the most common proteasome inhibitor (PI)-based triplet regimens for relapsed multiple myeloma as their second line of therapy (LOT2).MethodsThe study population consisted of patients who received a carfilzomib (K)-based regimen during the course of treatment for MM between 11/01/2013 and 02/29/2016, were ≥18 years old, were not enrolled in a clinical trial, and had at least 2 visits at a US Oncology Network (USON) clinic. PI-based triplet regimens received by at least 15 patients in LOT2 were considered for this analysis: K+lenalidomide with dexamethasone or prednisone (KRd), bortezomib+lenalidomide with either steroid (VRd), and bortezomib+cyclophosphamide with either steroid (VCyd). Data were captured on lines of therapy (LOT), systemic therapy regimens, and treatment administration dates from the US Oncology Network's iKnowMed® electronic health records (EHR). Treatment sequencing rules were created to define criteria for the advancement of the line of therapy based on the specific regimens, duration of use, and administration dates. TTNT was estimated from date of initiation of LOT2 therapy to the first administration date of the next line of therapy with the Kaplan-Meier method, using log-rank tests for comparison. Death or progression to next treatment were considered failure events. Patients who were lost to follow up or did not experience a failure event during the study period were censored. Hazards ratios (and 95% CIs) were estimated using multivariable Cox regression modeling, adjusting for baseline age, sex, race, geographic region of the practice, number of comorbidities, stage, body mass index (BMI), prior cancer history, performance status, and serum creatinine. A limitation of our real-world data is that a small proportion of LOT indicators may be misclassified due to data inconsistencies. Furthermore, while use of a large geographically dispersed cohort of community-based patients improves generalizability, the results from our data may not be completely generalizable to other community-based practices.ResultsA total of 718 patients received a K-containing regimen at some time (LOT 1 to LOT5) during the course of their MM treatment (Table 1); of these, 156 patients received a LOT2 PI-containing triplet including KRd (n =112; 71.8%), VRd (n = 27; 17.3%), and VCyd (n = 17; 10.9%). Mean baseline age for these 156 patients was 64.8 (SD: 11.3) years. In the KRd group, mean age was 64.7 (SD: 11.6) years, whereas in the VRd and VCyd groups, mean ages were 62.4 (SD: 10.9) and 69.1 (SD: 9.1), respectively. Overall, 57.7% of the study population was male. 64.3% of the KRd group were male, compared to 48.1% of the VRd group and 29.4% of the VCyd group. These PI-based regimen groups were not significantly different across a range of baseline clinical characteristics including number of comorbidities, stage at diagnosis, ECOG, and serum creatinine (Table). Median TTNT was greatest for the KRd group (25.3 months; 95% CI: 19.71-NR), compared to the VRd or VCyd groups (median TTNT for VRd: 10.2 months, 95% CI: 4.24-12.71, and for VCyd: 6.5 months,95% CI: 3.02-12.78; log-rank p<.0001). The adjusted HR for KRd was 0.19 (95% CI: 0.11-0.37), indicating an almost 80% lower risk of progression to next treatment or death among KRd patients, compared to patients who received VRd (referent) in LOT2. Patients receiving VCyd had a similar adjusted risk for progression to next treatment or death, compared to patients receiving VRd (adj. HR: 0.96, 95% CI: 0.43-2.13).ConclusionsOur findings indicate that MM patients who received KRd in LOT2 had significantly improved TTNT, compared to those who received VRd or VCyd. Considering the real-world nature of these data, the median TTNT observed with KRd appears to be consistent with the findings on progression-free survival for KRd in the phase 3 ASPIRE trial (median PFS: ITT population =26.3 months; LOT2 = 29.6 months). These findings confirm the value of KRd as an important therapeutic option for patients with MM at first relapse. [Display omitted] DisclosuresRifkin:McKesson Specialty Health: Employment; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees. Medhekar:Amgen Inc.: Employment, Equity Ownership. Amirian:McKesson Specialty Health: Employment. Wilson:McKesson Specialty Health: Employment. Boyd:McKesson Specialty Health: Employment. Mezzi:Amgen, Inc.: Employment, Equity Ownership. Panjabi:Amgen Inc.: Employment, Equity Ownership.

Understanding Ibrutinib Treatment Discontinuation Patterns for Chronic Lymphocytic Leukemia

Introduction: Ibrutinib is an orally administered Bruton's tyrosine kinase inhibitor (BTKi) approved in the US in 2014 for the treatment of patients with chronic lymphocytic leukemia (CLL) and CLL with 17p deletion. The goals of this study were to describe the patient population diagnosed with CLL and receiving treatment with ibrutinib in community practice, to evaluate ibrutinib discontinuation rates and reasons, and to further examine associated outcomes.Methods: Adult pts with CLL who initiated ibrutinib between 1/Jan/ 2013 and 31/Oct/2015 were identified retrospectively fromelectronic health records (EHR) of McKesson Specialty Health and followed through 30/Apr/2016 or last visit date documented in the pts' medical chart. Pts in clinical trials or with another primary cancer diagnosis were excluded. Demographic, disease and treatment characteristics were abstracted from structured data elements of the EHR and supplemented by manual chart abstraction. Overall survival (OS) was analyzed using Kaplan Meier analysis.Results: 447 pts, with a median follow-up of 20.0 mos (range= 0.03-38.0), were identified for this study. At ibrutinib initiation, median age was 64.0 yrs; 60.4% were male, 47.0% were identified as intermediate or high risk CLL (RAI stages I through IV) and 70.0% had an ECOG performance status of 0 or 1 (Table 1). The median initial ibrutinib dose was 420 mg daily with 83% of subjects starting from this dose. Median duration of ibrutinib treatment was 15.2 mos (range=0.2-37.9).Of 447 patients, 222 (49.7%) were continuing ibrutinib at the end of the observation period, 103 (23.0%) discontinued ibrutinib due to toxicity, 33 (7.4%) discontinued ibrutinib due to progression, 48 (10.7%) discontinued due to other reasons (adequate response achieved, financial, physician choice, patient choice) and 41 (9.2%) discontinued due to death.Median OS from ibrutinib initiation was similar between subjects discontinuing due to toxicity and due to progression. Patients discontinuing ibrutinib due to toxicity had 12 and 24-month survival probabilities of 88.0% (95% CI 79.8, 93.0) and 70.5% (95% CI 57.5, 80.2) respectively; patients discontinuing ibrutinib due to progression had 12 and 24-month survival of 81.8% (95% CI 63.9, 91.4) and 75.3% (95% CI 56.5, 86.8) respectively. Patients who continued ibrutinib had a 99.5% (95% CI 96.8, 99.9) overall survival at 24 months.Conclusions: This real world study evaluated ibrutinib treatment patterns and identified reasons for discontinuation and the subsequent outcomes in patients diagnosed with CLL. New treatment options, such as novel BTK inhibitors with improved tolerability, are needed to reduce the rate of discontinuation due to toxicities and thus extend the clinical benefits of continuous BTK inhibition in this disease setting. [Display omitted] DisclosuresSharman:Gilead Sciences, Inc.: Consultancy, Honoraria, Research Funding, Speakers Bureau; Novartis: Research Funding; Genentech: Research Funding. Black-Shinn:McKesson Specialty Health: Employment. Clark:McKesson Specialty Health: Employment, Equity Ownership. Bitman:Acerta Pharma: Employment; Astra Zeneca: Equity Ownership.

Development of a Predictive Model of Multiple Myeloma (MM) Patient (pt) Outcomes Based on Treatment Class Transitions Using the Connect® MMpatient Registry

Development of a Predictive Model of Multiple Myeloma (MM) Patient (pt) Outcomes Based on Treatment Class Transitions Using the Connect® MMpatient Registry

Results of an Interim Safety Analysis of a Phase 2 Study of Daratumumab (Dara) Plus Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) in Previously Untreated and Relapsed Patients (Pts) with Multiple Myeloma (MM)

Background: Dara is a monoclonal anti‐CD38 antibody approved for the treatment of relapsed and refractory MM, but is associated with an infusion related reaction (IRR) rate of 46% for infusion 1 and 2% for infusion 2, and a median duration of infusions 1 and 2 of 7.0 and 4.3 hours, respectively (US Prescribing Information). CyBorD is a commonly used bortezomib based regimen for MM. This study was designed to evaluate Dara-CyBorD, as well as administration of the first Dara infusion as a divided dose over 2 days, in pts with MM who are previously untreated or have relapsed following only one line of therapy. We report results from a planned interim analysis of the first 48 pts who completed C1 of study treatment, focusing on the safety and IRR profile of Dara.Methods: This is a multicenter, single-arm, open-label, Phase 2 study conducted at US community oncology centers. Key eligibility criteria include ≥ 18 years of age; documented MM per IMWG 2015 criteria; measurable MM; ECOG performance score of 0, 1, or 2; and no or one prior line of therapy. Approximately 100 pts will receive 4 to 8 28-day induction cycles of Dara-CyBorD, including oral cyclophosphamide 300 mg/m2 on Days 1, 8, 15, and 22; subcutaneous bortezomib 1.5 mg/m2 on Days 1, 8, and 15; and oral or IV dexamethasone 40 mg weekly. Dara is administered at a dose of 8 mg/kg IV on Days 1 and 2 of C1, then 16 mg/kg IV weekly from C1D8 through C2, then 16 mg/kg IV once every 2 weeks for C3-6, then 16 mg/kg IV once every 4 weeks for cycles 7-8. After completion of induction, pts may undergo an autologous stem cell transplant. All pts then receive 12 cycles of maintenance therapy with Dara 16 mg/kg IV every 4 weeks. Required pre-infusion medications are dexamethasone, acetaminophen, and diphenhydramine; montelukast is allowed at the investigator's discretion.Results: The first 48 pts completed 1 cycle of therapy with no discontinuations during C1. Median age was 62.5 (range 41-80) years, and 65% were male. Thirty-nine pts (81%) were previously untreated, and 9 pts (19%) had received 1 prior therapy. Forty-seven pts (98%) experienced at least 1 treatment emergent adverse event (TEAE) during C1, including 35 pts (73%) who experienced TEAE(s) attributed to Dara by the investigator. No grade 5 AE was reported during C1. The most commonly reported AEs during C1 were nausea (29%), fatigue (25%), diarrhea (23%), headache (17%), and chills (15%). Serious AEs (SAEs) occurred in 10% of pts during C1; no SAE was attributed to Dara by the investigator. IRRs occurred in 44% of pts, all grade ≤ 2, including 38% at C1D1 and 4% at C1D2. The most common IRRs were chills (13%), cough (6%), and nausea (6%). Respiratory IRRs occurred in 13% of pts, including cough (6%), dyspnea (4%), bronchospasm (2%), throat irritation (2%), and oropharyngeal pain (2%). The median infusion time was 4.3 hours for C1D1 and 3.5 hours for C1D2.Conclusion: The overall safety profile during C1 of Dara-CyBorD was consistent with that previously reported for Dara with no new safety concerns. Administration of the first Dara infusion as a split dose of 8 mg/kg/day over 2 days resulted in a similar IRR rate and a shorter median infusion time for C1D1 than the US prescribing information for single dose. No grade ≥ 3 IRRs were observed. These findings demonstrate that splitting of the first Dara infusion in the community setting is feasible, results in a similar IRR rate with no observed grade ≥ 3 IRRs, and reduces the median time for the first Dara infusion. DisclosuresYimer:Bellucum Pharma: Equity Ownership; Juno pharma: Equity Ownership. Melear:Janssen: Membership on an entity's Board of Directors or advisory committees. Faber:Millenium: Consultancy, Membership on an entity's Board of Directors or advisory committees; Onyx: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sanofi Aventis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees. Bensinger:Janssen: Membership on an entity's Board of Directors or advisory committees. Burke:Incyte: Consultancy; Bayer: Consultancy; Genentech: Consultancy; Celgene: Consultancy, Other: Travel grant; Gilead: Consultancy. Gunawardena:Janssen: Employment. Sean:Janssen: Employment, Equity Ownership. Parros:Janssen: Employment. Lutska:Janssen: Employment. Darif:Janssen: Employment, Equity Ownership. Londhe:Janssen: Employment, Equity Ownership. Qi:Janssen: Employment; Johnson & Johnson, LLC: Equity Ownership. Ukropec:Janssen: Employment. Lin:Janssen: Employment. Rifkin:McKesson Specialty Health: Employment; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees.

MCL Treatment Patterns and Outcomes: A Community Oncology Practice Experience

Introduction: Mantle cell lymphoma (MCL) is an aggressive form of non-Hodgkin lymphoma and is typically managed using chemoimmunotherapy and oral targeted therapies. However, there is a paucity of research examining the real-world treatment patterns and outcomes in the MCL population in community setting.Methods: Adults with MCL who initiated treatment between 1 January 2013 and 31 October 2016 were identified retrospectively from electronic health records (EHR) of McKesson Specialty Health and followed up until 30 April 2017. Patients in clinical trials were excluded. Demographic, disease and treatment characteristics were abstracted from structured data elements of the EHR. Overall survival (OS) was analyzed using Kaplan-Meier analysis and time to next treatment (TTNT: time from 1L treatment completion to 2L treatment initiation) was analyzed using descriptive statistics.Results: In total, 910 patients, with a median follow-up of 17.6 mos (range, 0.03-51.8), were included. Median age at treatment initiation was 70.7 years; 71.8% were male and 68.3% were initially diagnosed with stage IV MCL (Table 1). Of patients (n=170) with a known Eastern Cooperative Oncology Group (ECOG) score at diagnosis, 23.5% and 68.8% had an ECOG performance status of 0 and 1, respectively. Frequent 1L treatments included bendamustine + rituximab (41.0%) with a median treatment duration of 20.2 weeks (range, 0.1-220.1 weeks), rituximab monotherapy (17.6%) with a median treatment duration of 29.6 weeks (range, 0.1-216.2 weeks) and rituximab + cyclophosphamide + doxorubicin + vincristine +/- prednisone (R-CHO+/-P, 13.4%) with a median treatment duration of 16.7 weeks (range, 0.1-144.4 weeks). Of the 796 patients treated with a rituximab-containing regimen in the 1L, 168 patients (21.1%) were identified as having rituximab maintenance following 1L treatment.A total of 208 patients (22.9%) were treated further in the 2L setting with the most common regimens: ibrutinib monotherapy (18.3%), bendamustine + rituximab (14.4%), and rituximab monotherapy (11.1%). Median TTNT was 57.1 weeks (range 0.1-224.5 weeks) in the overall population who received 2L treatment.Median OS from 1L treatment initiation was not reached in the overall 1L treated population. OS did not differ by regimens utilized in the 1L setting (log-rank P=.2503). Survival probabilities at 50 months were 76.8% for patients initiating bendamustine + rituximab, 79.7% for rituximab monotherapy, 72.6% for R-CHO+/- P therapy.Conclusions: This is the first real-world study evaluating treatment patterns and outcomes in MCL in a large community oncology network. The most common frontline regimens utilized were bendamustine + rituximab and rituximab monotherapy with survival not differing by 1L regimen. Additional analyses evaluating treatment-related adverse events and associated outcomes for infused and oral treatments by line of therapy are ongoing. [Display omitted] DisclosuresSharman:Novartis: Research Funding; Genentech: Research Funding; Gilead Sciences, Inc.: Consultancy, Honoraria, Research Funding, Speakers Bureau. Black-Shinn:McKesson Specialty Health: Employment. Clark:McKesson Specialty Health: Employment, Equity Ownership. Karve:AstraZeneca: Employment, Other: Stocks.

Cost Offsets in the Treatment Journeys of Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

BackgroundMultiple new regimens combining different mechanisms of action and routes of administration are available for the treatment of RRMM. It is increasingly important to understand the differential costs of these regimens, including patient and caregiver burden of treatment and associated indirect costs. The objectives of this study were to determine the costs associated with treating RRMM with 2nd-line therapy and cost offsets associated with frequently used regimens in this setting.MethodsA 12-month (mo) treatment journey for RRMM was developed to reflect real-world clinical practice based on current treatment guidelines and input from hematologists/oncologists. Regimens used as 2nd- or 3rd-line therapy were included, incorporating thalidomide (T), lenalidomide (R), pomalidomide (Pom), bortezomib (V), carfilzomib (K), ixazomib (I), elotuzumab (E), daratumumab (D), panobinostat (Pa), cyclophosphamide (C), melphalan-prednisone (MP), and dexamethasone (d/dex). Specific regimens were: Rd, Vd, VRd, VCd, Pom-dex, Kd, MPT, VMP, KRd, IRd, ERd, DVd, and PaVd. Data on DRd were not available when the model was developed. A cost model was constructed to determine costs associated with 2nd-line treatment with these regimens, including direct (medical/laboratory [lab], drug, administration, pre-medication, prophylaxes, adverse event [AE]-related) and indirect (productivity loss, transportation, caregiving) costs incurred at the initiation of and during 2nd-line therapy, and for a subsequent line of therapy among patients who discontinued 2nd-line therapy due to disease progression or AEs.ResultsDrug cost represented the primary cost component of the total cost of 2nd-line therapy across all regimens; analyses excluding these costs highlight additional direct and indirect drivers of treatment journey costs. Total costs excluding drug costs (Fig 1) appeared highest with regimens with substantial rates of discontinuation due to AEs, such as MPT, and with triplet regimens in which one or more of the agents was administered by intravenous (IV) or subcutaneous (SC) infusion, such as DVd, KRd, PaVd, VRd, and ERd. Compared to other recently approved doublet or triplet regimens, excluding drug costs, IRd appeared less expensive than Kd, KRd, ERd, DVd, and PaVd, driven by lower administration costs, AE-related costs, and indirect costs. Direct medical costs, including medical visits, lab tests, administration costs, and costs for prophylaxes, were $140.97 for the all-oral regimens IRd, Rd, and Pom-dex (12-mo cost: $1,691.61). Direct medical costs were higher for V-containing regimens, such as Vd ($707.75; 12-mo cost: $8,493.01), VRd ($708.29; 12-mo cost: $8,499.50), and VCd ($561.72; 12-mo cost: $6,740.69), compared to all-oral regimens, driven by higher administration and lab test costs. Similarly, compared to all-oral regimens, direct medical costs were higher for regimens containing novel drugs requiring clinic administration, such as Kd ($1,009.65; 12-mo cost: $12,115.75), KRd ($1,010.19; 12-mo cost: $12,122.24), ERd ($795.00; 12-mo cost: $9,539.99), DVd ($1,122.63; 12-mo cost: $13,471.61), and PaVd ($707.75; 12-mo cost: $8,493.01). AE management costs were estimated on average (all regimens) to be $243.37 per 28-day cycle (12-mo cost: $2,920.42), and were lower with Vd ($103.58; 12-mo cost: $1242.91) and higher with Pom-dex ($395.58; 12-mo cost: $4,747.00) and PaVd ($306.02; 12-mo cost: $3,672.20). Indirect costs (Fig 2) were higher for regimens requiring more frequent or longer drug administration, such as DVd ($702.78; 12-mo cost: $8,433.33), Kd, and KRd ($511.26; 12-mo cost: $6,135.06), and lowest for all-oral regimens ($78.19; 12-mo cost: $938.30). Adjusted cost offsets will be reported for subgroups with high unmet need, including frail patients, patients with barriers to physician access, and patients with pre-existing cardiac disease or other comorbidities.ConclusionsExcluding drug acquisition costs, differences in total costs between regimens for RRMM were driven primarily by administration costs, AE-related costs, and indirect costs. The results of this study of costs accrued over 12 mos for specified regimens demonstrate the lower treatment burden (direct medical costs) and indirect costs associated with administering all-oral regimens compared to the specified regimens requiring frequent and/or lengthy IV or SC administration. [Display omitted] DisclosuresAilawadhi:Takeda: Consultancy, Honoraria; Pharmacyclics: Research Funding; Novartis: Consultancy, Honoraria; Amgen: Consultancy, Honoraria. DerSarkissian:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Research Funding; Novartis Pharmaceuticals Corporation: Employment. Duh:Novartis Pharmaceuticals Corporation: Research Funding; Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Research Funding. Lafeuille:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd: Research Funding; Janssen Scientific Affairs, LLC: Research Funding. Posner:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Research Funding. Ralston:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Research Funding. Zagadailov:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Ba-Mancini:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Rifkin:Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; McKesson Specialty Health: Employment; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees.

Uncovering the Blind Spot of Clinical Trials: First Report of Baseline Characteristics of Newly Diagnosed (ND) and Relapsed/Refractory (RR) Multiple Myeloma (MM) Patients (Pts) in Insight-MM, a Global, Prospective, Observational Study

Uncovering the Blind Spot of Clinical Trials: First Report of Baseline Characteristics of Newly Diagnosed (ND) and Relapsed/Refractory (RR) Multiple Myeloma (MM) Patients (Pts) in Insight-MM, a Global, Prospective, Observational Study

Carfilzomib Dosing Patterns and Time to Next Treatment Among Adult Patients with Multiple Myeloma Treated in the US Community Oncology Setting

Carfilzomib Dosing Patterns and Time to Next Treatment Among Adult Patients with Multiple Myeloma Treated in the US Community Oncology Setting

A successful model of biosimilar adoption in a community oncology practice.

6514 Background: The emergence of biosimilars creates an opportunity for more cost-effective treatment. Utilization of biologics in cancer care has increased and accounts for 70% of oncologic drug spending growth from 2010 to 2015. Biosimilars can play a vital role in controlling this rapid rise in cost. Practices focused on Value Based Care arrangements, such as the Oncology Care Model, can reduce total cost of care by increasing utilization of biosimilars. The process of interchange is complicated by the designation of each biosimilar which prevents simple interchange. Communication with physicians and the healthcare team along with patient education and consent must be performed. We describe a successful model for therapeutic interchange of brand drugs to biosimilars. Methods: Texas Oncology elected to increase utilization of biosimilars in 2020. We collaborated with McKesson Specialty Health to create educational materials for patients and clinical staff. Communication was sent to all personnel about the therapeutic interchange process. A central pharmacy team reviewed all new orders and substituted a biosimilar for brand, unless a payer insisted on origin drug or a biosimilar not in the practice formulary. Additionally, a report was generated weekly of all existing patients who would benefit from switching. The pharmacists, upon consultation with the physician, then substituted a biosimilar for brand drug. Patients were then educated and re-consented. We started with rituximab in 07/2020 followed by bevacizumab in 09/2020 then trastuzumab in 10/2020. Results: The table below shows our conversion rate for all administrations. We were able to increase utilization of biosimilars from January of 2020 to December of 2020 from 5% to 80% for Rituximab, 9% to 88% for bevacizumab and 8% to 74% for trastuzumab. Based on average ASP for a 70 kg patient, the potential savings per administration is $550 for bevacizumab, $850 for trastuzumab, and $1400 for rituximab. In one month alone, this project dramatically reduced cost by $4 million or 21% by conversion to these three biosimilars. Additional savings can be realized with the use of biosimilar multi-dose vials vs single dose vials. Conclusions: Our comprehensive team approach successfully deploys therapeutic interchange of biosimilars for brand drugs in a community oncology practice which leads to substantial cost savings. This has real implications in controlling the total cost of care.[Table: see text]

964P - Lenvatinib (Len) alone or in combination with everolimus (Eve) in heavily pretreated patients (pts) with metastatic renal cell carcinoma (mRCC) after immune checkpoint inhibitors (ICI) and VEGFR-targeted therapies: A single-institution experience

BackgroundICI and VEGFR-targeted therapies are the primary treatments for mRCC. Len plus Eve is currently approved based on improved progression-free survival (PFS) in pts with progressive disease after one prior VEGFR-targeted therapy. However, its efficacy beyond second-line, and after ICI, is not well defined. MethodsWe conducted a retrospective study of pts with mRCC who were treated with Len alone, or in combination with Eve, after at least 2 prior lines of therapy, including ICI and VEGFR-TKI. We report clinical benefit (CB), defined as partial response (PR) + stable disease (SD), PFS, overall survival (OS), and adverse events (AE). ResultsBetween 11/2016 and 2/2019, we identified 40 pts with mRCC who were treated with Len +/- Eve. Median age was 59 years (range, 34-76); 62.5% were male; 52.5% had ECOG PS 1 and 35% had ECOG PS 2; 77.5% had clear cell histology; 85% had prior nephrectomy and 95% had metastatic disease in >/= 3 sites; 2.5% had IMDC favorable-risk, 87.5% intermediate-risk, and 10% poor-risk disease. The median number of prior lines of therapy was 4 (range, 2-10); 70% received Len+Eve and 62.5% were treated with Len +/- Eve as 5th-line or later. All pts had prior ICI exposure, primarily nivolumab monotherapy (70%), and 87.5% received >/= 2 prior VEGFR-TKIs. CB was achieved in 67.5% (30% PR+37.5% SD). At a median follow up of 8.5 months (mo), median PFS was 4.2mo (95% CI, 3.4-6.5), with a 6-mo PFS probability of 34% (95% CI, 21%-54%). Median OS was 10.8mo (95% CI, 5.4-13.3), with a 1-year OS probability of 37% (95% CI, 21%-65%). Twenty-three pts (57.5%) have died, and of those only 4 received further therapies after Len +/- Eve. Dose reduction was required in 45% of pts, and the most common grade 3 or 4 AEs were proteinuria (17.5%), fatigue (10%), and diarrhea (10%). Treatment was discontinued in 4 pts (10%) because of toxicity. ConclusionsLen alone and in combination with Eve demonstrated clinical benefit, with an overall response rate of 30%, and was well tolerated in heavily pretreated pts with mRCC after prior ICI and VEGFR-targeted therapies, supporting its use in this patient population. Legal entity responsible for the studyThe authors. FundingHas not received any funding. DisclosureZ. Lim: Speaker Bureau / Expert testimony: Exelixis. M.T. Campbell: Honoraria (self), Advisory / Consultancy: Eisai; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), non-branded educational programs: EMD Serono; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), non-branded educational programs: Pfizer; Honoraria (self), Advisory / Consultancy: Genentech; Honoraria (self), Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Apricity Health; Research grant / Funding (self): Exelixis; Research grant / Funding (self): Janssen; Speaker Bureau / Expert testimony, non-branded educational programs: Bristol-Meyers Squibb; Speaker Bureau / Expert testimony, non-branded educational programs: Roche; Speaker Bureau / Expert testimony, non-branded educational programs: Merck. A.Y. Shah: Honoraria (self), Research grant / Funding (self): Eisai; Honoraria (self): Oncology Information Group; Honoraria (self): Roche; Research grant / Funding (self): Bristol-Myers Squibb; Research grant / Funding (self): EMD Serono. A. Zurita Saavedra: Speaker Bureau / Expert testimony: McKesson Specialty Health; Speaker Bureau / Expert testimony: Janssen-Cilag, S.A.DEC.V.; Advisory / Consultancy: Incyte; Advisory / Consultancy: Pfizer. E. Jonasch: Advisory / Consultancy, Research grant / Funding (self): Exelixis; Advisory / Consultancy, Research grant / Funding (self): Novartis; Research grant / Funding (self): Peloton; Advisory / Consultancy, Research grant / Funding (self): Pfizer; Advisory / Consultancy: Eisai; Advisory / Consultancy: Genentech; Advisory / Consultancy: Ipsen; Advisory / Consultancy: Roche. N.M. Tannir: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Exelixis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Nektar; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Calithera Biosciences Inc.; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Eisai Medical Research; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Ono Pharmaceutical; Advisory / Consultancy, Travel / Accommodation / Expenses: Oncorena; Research grant / Funding (self): Epizyme; Research grant / Funding (self): Mirati Therapeutics. All other authors have declared no conflicts of interest.

Treatment patterns and outcomes among patients with recurrent/metastatic squamous cell carcinoma of the head and neck.

Cetuximab was approved in 2008 for treating recurrent/metastatic (R/M) head-and-neck squamous-cell carcinoma (HNSCC), and this study assessed the utilization of cetuximab for R/M-HNSCC in a real-world setting. Adult patients with R/M-HNSCC, who initiated systemic therapy between 1 September2011 and 31 December 2014 and followed through 31 December2015, were identified from iKnowMed electronic-health-records database (McKesson Specialty Health) supplemented with manual chart-abstraction. For 325 R/M-HNSCC patients; median age 62years; 82% males, 67% had oropharyngeal cancer, most common first-line (1L) regimen was platinum-based combinations (76%), of whom only 8% received platinum + cetuximab +/- 5-fluorouracil. Despite US FDA approval and National Comprehensive Cancer Network guidelines recommending use of cetuximab for palliative treatment of R/M-HNSCC, our study demonstrates low utilization in 1L and 2L settings, underscoring the need to understand reasons for low utilization.

Treatment Patterns and Outcomes of 159 Ibrutinib-Treated MCL Patients in the United States: A Retrospective Electronic Medical Record Database and Chart Review Study

IntroductionIbrutinib, a Bruton's tyrosine kinase inhibitor, was approved in the U.S. for the treatment of relapsed or refractory mantle cell lymphoma (MCL) in November of 2013. However, real-world data on ibrutinib use for the treatment of MCL is limited. The purpose of this study was to examine ibrutinib use, dosages, and reasons for treatment discontinuation among MCL patients treated in a community oncology practice setting.MethodsThe study population consisted of adult (≥18 year old) MCL patients treated with ibrutinib between November 1, 2013 and October 31, 2016, who were not enrolled in a clinical trial and had at least 2 visits to a US Oncology Network (USON) clinic. Patients with other primary cancers were excluded. Patient data were sourced from the USON's electronic health records system, iKnowMed (iKM)™. The structured iKM database provided information on demographics and clinical and treatment characteristics. Manual chart review was used to confirm ibrutinib treatment patterns. Duration of ibrutinib therapy (DOT), overall survival (OS), and progression-free survival (PFS) from systemic treatment initiation were estimated using Kaplan-Meier methods. Events were defined as death in the OS analysis, and progression or death in the PFS analysis. Patients were censored if their treatment was ongoing for DOT. Censors for OS and PFS were patients lost to follow up or those who did not experience a failure event within the study period.Results159 eligible MCL patients were identified through iKM. The majority of patients were Caucasian (n=141, 88.7%), male (n=121, 76.1%), and diagnosed with Stage IV disease (n=117, 73.6%). Median follow-up for the population was 16.1 months. Approximately 7.5% (n=12) of patients received ibrutinib as first-line therapy (1L), compared to 54.1% (n=86) in 2L and 38.4% (n=61) in 3L or beyond. Median ibrutinib dose at initiation was 560mg (range: 140-700). During ibrutinib treatment, 16.4% (n=26) of patients experienced a dose reduction. Dose holds occurred in 30.2% (n=48), 66.7% (n=32) due toxicities. The overall discontinuation rate was 83.6% The primary reason for discontinuation was disease progression (n=46, 34.6%) followed by toxicities (n=34, 25.6%). Median DOT was higher for patients initiating treatment in 3L+ (14.9: 95% CI 8.8-17.1) compared to other lines. Median PFS was 19.6 (95% CI: 16.5-24.3) for the overall population and median OS was 25.8 months (95% CI: 19.9-not reached).ConclusionsOur real-world findings on survival are consistent with those from clinical trials on ibrutinib in relapsed/refractory MCL, although our observed discontinuation rate (~84%) was higher than that of the trial (~58%), which had a similar median follow-up time (16.1 months vs. 15.3 months, respectively). Our findings provide additional data on MCL treatment patterns and patient outcomes in clinical practice. [Display omitted] DisclosuresSharman:Acerta: Consultancy, Research Funding; Pharmacyclics, an AbbVie Company: Consultancy, Research Funding. Kabadi:AstraZeneca: Employment. Clark:McKesson Specialty Health: Employment, Equity Ownership. Amirian:McKesson Specialty Health: Employment. Andorsky:Celgene: Research Funding; CTI BioPharma: Consultancy, Research Funding; AstraZeneca: Consultancy; Genentech: Consultancy.

Safety of Split First Dosing Vs Standard Dosing Administration of Daratumumab Among Multiple Myeloma Patients Treated in a US Community Oncology Setting: A Real-World Observational Study

INTRODUCTIONDaratumumab (DARA) is a human IgGκ monoclonal anti-CD38 antibody for treatment of multiple myeloma (MM). In clinical trials, median durations for the 1st, 2nd and subsequent infusions were 7.0, 4.3 and 3.5 hours, respectively. To optimize the first infusion duration of DARA, the US Oncology Network (USON), a community oncology practice network, implemented a split first dose protocol. The USON split first dose protocol requires 2 IV bags, one for Day 1 and one for Day 2 of consecutive days. On each day, DARA is diluted with normal saline to a total volume of 500 mL. On each day, DARA is administered at 50 mL/hour for one hour. If no infusion events occur, the infusion rate can be increased in 50 mL/hour increments every hour to a maximum of 200 mL/hour. While the split first dose may increase convenience, limited information is available on the safety of split first dose DARA. METHODSThis was a retrospective, observational study of adult MM patients who initiated DARA in routine care within USON between 11/01/2015 - 06/30/2017 to compare infusion times and safety of DARA split first dose vs DARA standard dose schedule (i.e., 1 infusion of 16 mg/kg per FDA-approved prescribing information). In this study, patients were grouped into either the split first dose cohort or the standard dose schedule cohort according to the dosing schedule that they had experienced. Data were sourced from USON's electronic healthcare record system. Information on infusion reactions was available only through chart review, which was conducted among a random sample of patients in each study cohort. Descriptive analyses were conducted to compare demographic, clinical and treatment characteristics of MM patients who received split first dose schedule vs standard dosing schedule. Chi-square tests or Fisher's exact tests were used to assess associations between categorical variables. ANOVA/t-tests or Kruskal-Wallis tests were used to assess associations for continuous variables. A p-value of <0.05 was considered as statistically significant. RESULTSOf the 622 patients included in the landscape analysis, 365 (58.5%) had received the split first dose schedule and 258 (41.5%) had received the standard dosing schedule. Overall, the median age was 63.6 years, 54.2% male and 78.3% Caucasian. The utilization of the split first dose schedule increased significantly over time with more patients in 2017 Q2 having received split dose vs standard dose (p< 0.0001). Karnofsky performance status (KPS) scores differed significantly between patients treated with split first dose vs standard dose (p=0.02). No other baseline differences between groups were found. The median infusion duration was 4.5 hours for Day 1 of split first dose and 6.5 hours for standard dose (p<0.0001). Among patients selected for chart review (n = 302), 47.8% (88/184) of split first dose patients and 48.3% (57/118) of standard dose patients experienced at least one infusion reaction. The most common infusion reactions included lower-respiratory (26.1%), upper-respiratory (17.2%) and gastrointestinal reactions (12.5%), chills (8.9%), flushing (6.6%), with no statistically significant differences between study groups for any infusion reaction. Among patients treated with split first dose DARA, 3.8% experienced an infusion reaction during Day 2 of the split dose schedule. CONCLUSIONSAs a retrospective observational study at community-based oncology clinics, these findings provide real-world evidence on the infusion time and safety of the first infusion of DARA. This study found that the utilization of split first dose has increased over time. Interestingly, more patients in the split dose group had higher KPS scores than patients in the standard dose group, which may be due to selection of patients, at least initially, for the split first dose. This study found also that the length of the first day of the split first dose schedule is shorter than the length of the standard dosing schedule. Additionally, although determination of severity or grade was not feasible in this study, the proportion of patients in split first and standard dosing schedule groups who experienced infusion reactions was equal. This study suggests that the split first dose is comparable to the standard dose schedule and may be a practical option for patients and institutions seeking options to manage the operational considerations of DARA administrations. DisclosuresRifkin:Takeda: Consultancy; EMD Serono: Consultancy; Sandoz: Consultancy; Celgene: Consultancy; McKesson: Equity Ownership; Boehringer Ingelheim: Consultancy; Amgen: Consultancy. Singer:Janssen Scientific Affairs, LLC: Research Funding. Aguilar:McKesson Specialty Health: Employment. Baidoo:McKesson Specialty Health: Employment. Maiese:Janssen Scientific Affairs,LLC: Employment, Equity Ownership.