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Conference/Presentation Title: | CLL-186 interim results from ASSURE: a phase 3b safety study of acalabrutinib in patients with chronic lymphocytic leukemia. | Authors: | Opat S. ;Awan F.T.;Fogliatto L.;Nikitin E.;Czerwinski J.;Santucci Alves da Silva R.;Jujjavarapu S.;Samoilova O.;Dartigeas C.;Tran H. ;de la Serna J.;Banerji V.;Magnano Mayer L.;Hart J.;von Tresckow J.;Poulsen C.B.;Seong Eom K.;Merli M.;John E.;Munley J.;Hakre S.;Hermann R.;Niemann C.U. | Monash Health Department(s): | Haematology | Institution: | (Opat) Monash University and Monash Health, Melbourne, Australia (Awan) University of Texas Southwestern Medical Center, Dallas, United States (Fogliatto) Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (Nikitin) S.P. Botkin's City Hospital, Moscow, Russian Federation (Czerwinski) Flinders Medical Centre, Bedford Park, Australia (Santucci Alves da Silva) Instituto Hemomed, Sao Paulo, Brazil (Jujjavarapu) Illinois Cancer Care, Peoria, United States (Samoilova) Regional Clinical Hospital, Nizhny Novgorod, Russian Federation (Dartigeas) CHU Tours, Tours, France (Tran) Akershus University Hospital, Lorenskog, Norway (de la Serna) Hospital 12 de Octubre, Madrid, Spain (Banerji) University of Manitoba and CancerCare Manitoba Research Institute, MB, Canada (Magnano Mayer) Hospital Clinic-IDIBAPS, University of Barcelona, Barcelona, Spain (Hart) BC Cancer-Victoria, Victoria, Canada (von Tresckow) West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany (Poulsen) Zealand University Hospital, Roskilde, Denmark (Seong Eom) The Catholic University of Korea, Seoul, South Korea (Merli) Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy (John) AstraZeneca, Cambridge, United Kingdom (Munley) AstraZeneca, Wilmington, United States (Hakre, Hermann) AstraZeneca, Gaithersburg, United States (Niemann) Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark |
Presentation/Conference Date: | 27-Aug-2024 | Copyright year: | 2024 | Publisher: | Elsevier Inc. | Publication information: | Clinical Lymphoma, Myeloma and Leukemia. Conference: Proceedings of the Society of Hematologic Oncology 2024. GRB Convention Center, Houston United States. 24(Supplement 1) (pp S347), 2024. Date of Publication: September 2024. | Journal: | Clinical Lymphoma, Myeloma and Leukemia | Abstract: | Context: Acalabrutinib is a second-generation Bruton tyrosine kinase inhibitor approved for treatment-naive (TN) or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Objective(s): To report interim safety results from ASSURE (NCT04008706) evaluating acalabrutinib monotherapy in patients with CLL in a real-world clinical practice setting. Design(s): Multicenter, open-label, single-arm, phase 3b trial. Patient(s): Patients aged >=18 years with CLL requiring therapy and ECOG performance status <=2 enrolled into 1 of 3 cohorts (TN, R/R, or ibrutinib intolerant [IbrI]). Intervention(s): Oral acalabrutinib 100 mg twice daily for 48 cycles of 28 days each (beyond if still benefitting from drug) or until disease progression or discontinuation for any reason. Main Outcome Measure(s): Frequency of all treatment-emergent adverse events (TEAEs). Result(s): A total of 552 patients received treatment (TN, n=310; R/R, n=202; IbrI, n=40). Median age overall was 69.5 years (20% had del(17p)/TP53m, 68% had uIGHV). Median number of prior therapy lines was 1 and 2 in R/R and IbrI cohorts, respectively. At data cutoff (June 15, 2023), 64% remained on treatment. Median (range) duration of exposure was 32.1 (0.2-43.6), 32.3 (0.6-41.5), and 20.5 (0.7-33.0) months in the TN, R/R, and IbrI cohorts, respectively. Estimated proportion of patients remaining on treatment at 30 months (95% CI) by Kaplan-Meier was 71% (66-76), 62% (55-69), and 45% (27-62) in the TN, R/R, and IbrI cohorts, respectively. Grade >=3 TEAEs were reported in 57% of patients overall (TN, 54%; R/R, 63%; IbrI, 45%), most commonly COVID-19 (13%), pneumonia (7%), anemia (6%), and COVID-19 pneumonia (5%). TEAEs led to treatment discontinuation in 19% of patients. Incidences of atrial fibrillation/flutter, hypertension, and major hemorrhage were low. TEAEs with outcome of death were reported in 56 patients, most occurring in patients with confirmed/suspected COVID-19 (n=41). TEAE deaths in patients without confirmed/suspected COVID-19 (n=15) included infections/infestations (n=4) and neoplasms (malignant/unspecified; n=4). Conclusion(s): In this interim analysis of ASSURE, the safety profile of acalabrutinib in patients with CLL in a real-world clinical setting was consistent with previous clinical studies, except for COVID-19 TEAEs, which were commonly observed as study enrollment spanned the COVID-19 pandemic. No new safety signals were reported.Copyright © 2024 Elsevier Inc. | Conference Name: | Proceedings of the Society of Hematologic Oncology 2024 | Conference Start Date: | 2024-09-04 | Conference End Date: | 2024-09-07 | Conference Location: | GRB Convention Center, Houston, United States | DOI: | http://monash.idm.oclc.org/login?url=https://dx.doi.org/10.1016/S2152-2650%2824%2901267-9 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/52339 | Type: | Conference Abstract | Subjects: | anemia atrial fibrillation chronic lymphatic leukemia coronavirus disease 2019 COVID-19 pneumonia hypertension |
Type of Clinical Study or Trial: | Observational study (cohort, case-control, cross sectional, or survey) |
Appears in Collections: | Conferences |
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