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Abstract EP783 MARGINAL ZONE LYMPHOMA (MAGNOLIA STUDY)

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Abstract EP783 MARGINAL ZONE LYMPHOMA (MAGNOLIA STUDY) PHASE 2 STUDY OF ZANUBRUTINIB IN PATIENTS WITH RELAPSED/REFRACTORY Abstract EP783 MARGINAL ZONE LYMPHOMA (MAGNOLIA STUDY) Stephen Opat,1,2 Alessandra Tedeschi,3 Kim Linton,4 Pamela McKay,5 Bei Hu,6 Henry Chan,7 Jie Jin,8 Magdalena Sobieraj-Teague,9 Pier Luigi Zinzani,10 Morton Coleman,11 Peter Browett,12 Xiaoyan Ke,13 Mingyuan Sun,14 Robert Marcus,15 Craig Portell,16 Catherine Thieblemont,17 Kirit Ardeshna,18,19 Fontanet Bijou,20 Patricia Walker,21 Eliza Hawkes,22-24 Sally Mapp,25 Shir-Jing Ho,26 Melannie Co,27 Xiaotong Li,27 Wenxiao Zhou,27 Massimo Cappellini,27 Chris Tankersley,27 Jane Huang,27 and Judith Trotman28 1Monash Health, Clayton, Victoria, Australia; 2Clinical Haematology Unit Monash University, Clayton, Victoria, Australia; 3ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy; 4The Christie, Manchester, UK; 5Beatson West of Scotland Cancer Centre, Glasgow, UK; 6Levine Cancer Institute/Atrium Health, Charlotte, NC, USA; 7North Shore Hospital, Auckland, New Zealand; 8The First Affiliated Hospital, Zhejiang University, Hangzhou, China; 9Flinders Medical Centre, Bedford Park, Australia; 10Institute of Hematology “Seràgnoli” University of Bologna, Bologna, Italy; 11Clinical Research Alliance, Lake Success, NY, USA; 12Auckland City Hospital, Grafton, New Zealand; 13Peking University Third Hospital, Beijing, China; 14Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China; 15Sarah Cannon Research Institute UK, London, UK; 16University of Virginia Health System, Charlottesville, VA, USA; 17APHP, Hôpital Saint-Louis, Hemato-oncology, Paris University Diderot, Paris, France; 18 Department of Haematology, University College London NHS Foundation Trust, London, UK; 19UCLH NIHR Biomedical Research Centre, London, UK; 20Institut Bergonié, Bordeaux, France; 21Peninsula Private Hospital, Frankston, Australia; 22Olivia Newton-John Cancer Research Institute at Austin Health, Heidelberg, Victoria, Australia; 23Eastern Health, Box Hill, Victoria, Australia; 24University of Melbourne, Melbourne, Victoria, Australia; 25Department of Haematology, Princess Alexandra Hospital, Brisbane, Australia and Faculty of Medicine, University of Queensland, Brisbane, Australia; 26Department of Haematology, St George Hospital, Sydney, New South Wales, Australia; 27BeiGene (Beijing) Co., Ltd., Beijing, China and BeiGene USA, Inc., San Mateo, CA, USA; and 28Concord Repatriation General Hospital and University of Sydney, Concord, Australia INTRODUCTION RESULTS (CONTINUED) • B-cell receptor-mediated signaling has been identified as a critical step in marginal zone lymphoma (MZL) pathogenesis1 Table 1. Patient and Disease Characteristics Figure 4. Subgroup Analysis of ORR by Independent Review Figure 6. PFS by Independent Review Table 4. TEAEs of Interest • Bruton tyrosine kinase (BTK) plays a critical role in B-cell receptor signaling, which mediates B-cell Characteristic Total (N=68) 100 All grade Grade ≥3 proliferation, migration, and adhesion2-4 a TEAE of interest (N=68) (N=68) Patients/n ORR (95% CI) 90 First-generation BTK inhibitor ibrutinib has shown activity in relapsed/refractory (R/R) MZL, Age, median (range), years 70 (37-95) – Infection 31 (45.6) 11 (16.2) demonstrating a 48% overall response rate (ORR)5 80 Age category, n (%) All patients 45/66 68.2 (55.56-79.11) Hemorrhage 25 (36.8) 0 • Zanubrutinib (BGB-3111) is a next-generation BTK inhibitor designed to maximize BTK occupancy and ≥65 years 41 (60.3) 70 minimize off-target inhibition of TEC- and EGFR-family kinases ≥75 years 19 (27.9) Age group 60 Diarrhea 15 (22.1) 2 (2.9) Zanubrutinib has been shown to be an irreversible, highly potent, selective, and bioavailable BTK – <65 years 15/26 57.7 (36.92-76.65) Thrombocytopeniaa 10 (14.7) 3 (4.4) inhibitor with potentially advantageous pharmacokinetic/pharmacodynamic properties6 Male, n (%) 36 (52.9) 50 ≥65 years 30/40 75.0 (58.80-87.31) b • The safety and efficacy of zanubrutinib in patients with R/R MZL were evaluated in the MAGNOLIA ECOG performance status, n (%) 40 Neutropenia 9 (13.2) 7 (10.3) study <75 years 28/48 58.3 (43.21-72.39) Second primary malignancyc 5 (7.4) 3 (4.4) 0-1 63 (92.6) Probability of PFS 30 – Study enrollment is complete; a total of 68 patients received at least 1 dose of zanubrutinib ≥75 years 17/18 94.4 (72.71-99.86) d Disease status, n (%) 20 Atrial fibrillation/flutter 2 (2.9) 1 (1.5) PFS rates at 12 and 15 months: Relapsed 44 (64.7) Disease status 10 Hypertension 2 (2.9) 1 (1.5) STUDY OBJECTIVES 82.5% (95% CI, 70.55-89.93) Refractory 22 (32.4) Relapsed 31/43 72.1 (56.33-84.67) 0 Major hemorrhage 0 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 • The primary endpoint was ORR as determined by an independent review committee based on the aIncludes thrombocytopenia and platelet count decreased. 7 Refractory 14/21 66.7 (43.03-85.41) b Lugano 2014 classification MZL subtypes, n (%) Months after first dose Includes neutropenia and neutrophil count decreased. Number at Risk cIncludes basal cell and squamous cell carcinoma (in 2 patients with history of skin cancer); papillary thyroid carcinoma (in 1 patient with pre-existing thyroid nodule); recurrent bladder cancer (in 1 patient with history of bladder cancer), and acute myeloid leukemia (in 1 patient with prior chemotherapy with alkylating agents). Extranodal 26 (38.2) 66 64 63 59 58 56 49 48 47 45 41 18 18 18 18 18 17 0 d Bulky disease Atrial fibrillation occurred in a patient with pre-existing atrial fibrillation (21 days after end of treatment due to disease progression). Nodal 26 (38.2) PFS, progression-free survival. TEAE, treatment-emergent adverse event. METHODS LDi ≤5 cm 26/42 61.9 (45.64-76.43) Splenic 12 (17.6) • The MAGNOLIA (BGB-3111-214) is a phase 2, single-arm, multicenter study of zanubrutinib in patients LDi >5 cm 19/24 79.2 (57.85-92.87) Figure 7. DOR by Independent Review with R/R MZL who had received ≥1 CD20-based regimen (Figure 1) Unknowna 4 (5.9) SUMMARY 100 Lymphoma involvement in bone marrow, n (%) 29 (42.6) Baseline extra-nodal disease Figure 1. Study Schema 90 • The MAGNOLIA study met its primary endpoint Prior lines of systemic therapy, median (range) 2 (1-6) Yes 34/52 65.4 (50.91-78.03) 80 • Zanubrutinib was highly active with a favorable safety profile in patients with R/R MZL aFour patients presented with both nodal and extranodal lesions; investigators were unable to classify the MZL subtype. No 11/14 78.6 (49.20-95.34) Primary Endpoint: ECOG, Eastern Cooperative Oncology Group; MZL, marginal zone lymphoma. 70 • After a median study follow-up of 15.7 months: Zanubrutinib ORR by IRC using Lugano7 R/R MZL – High ORR of 68.2% and CR rate of 25.8% by independent review monotherapy Bone marrow involvement 60 (N=68) Key Secondary Endpoints: Figure 3. ORR by (A) Independent Review and (B) Investigator Assessment • ORR higher than prespecified null ORR of 30% (P<0.0001) (160 mg BID) Yes 19/29 65.5 (45.67-82.06) 50 ORR by PI, PFS, OS, DOR, Safety A B • Responses were observed in all MZL subtypes No 26/37 70.3 (53.02-84.13) 100 100 40 – Median PFS and median DOR not reached BID, twice a day; DOR, duration of response; IRC, independent review committee; MZL, marginal zone lymphoma; ORR, overall response rate; OS, overall survival; PFS, progression- 30 • 93% of responders were progression/death-free at 12 months after initial response free survival; PI, principal investigator; R/R, relapsed/refractory. Prior line of systemic therapy Probability of DOR 90 90 • PFS rate was 82.5% at 15 months <3 36/48 75.0 (60.40-86.36) 20 80 80 – Treatment discontinuation due to AEs occurred in 4 patients; none were considered ORR 74.2% ≥3 9/18 50.0 (26.02-73.98) 10 DOR rate at 12 months: KEY ELIGIBILITY CRITERIA 93% (95% CI, 79.8-97.7) related to zanubrutinib 70 ORR 68.2% 70 0 – Grade 5 AEs occurred in 3 patients (including 2 patients who died from COVID-19 • Age ≥18 years 25.8% Prior treatment 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 60 60 pneumonia) • Histologically confirmed MZL including splenic, nodal, and extranodal subtypes Months after first response 25.8% RCVP 20/25 80.0 (59.30-93.17) Number at Risk – Atrial fibrillation/flutter occurred in 2 patients Previously received ≥1 CD20-directed regimen, with documented failure to achieve at least partial 50 50 45 44 44 41 40 40 35 33 28 17 17 17 15 14 2 0 • RCHOP 9/17 52.9 (27.81-77.02) – No major hemorrhage was reported response or documented progressive disease after the most recent systemic treatment DOR, duration of response. 40 40 BR 16/22 72.7 (49.78-89.27) • Measurable disease by computerized tomography or magnetic resonance imaging Best response (%) Best response (%) R-lenalidomide 1/2 50.0 (1.26-98.74) • Adequate organ function 30 30 Table 3. Safety Summary Rituximab monotherapy 10/15 66.7 (38.38-88.18) • No prior BTK inhibitor exposure 48.5% N=68 20 42.4% 20 REFERENCES CHOP 2/3 66.7 (9.43-99.16) n (%) 1. Seiler T, Dreyling M. Expert Opin Investig Drugs. 2017;26(8):909-915. 10 10 2. Rickert RC. Nat Rev Immunol. 2013;13(8):578-591. RESULTS R-chlorambucil 2/5 40.0 (5.27-85.34) Patients with at least 1 TEAE 65 (95.6) 3. Choe H, Ruan J. Oncology (Williston Park). 2016;30(9):847-858.
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