Immunotherapies for aplastic anemia

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1 Workshop on Hematology and Bone Marrow Transplant May 11 12, 2018, São Paulo Immunotherapies for aplastic anemia Diego Villa Clé, MD, PhD Attending Physician Hospital das Clínicas Faculdade de Medicina de Ribeirão Preto - USP

2 % Tcell suppression AA an autoimmune disease Autologous recovery after allo HSCT in AA Immunosuppression needed in syngeneic HSCT IFN levels Treg Controls AA Controls AA 1- Thomas et al. Exp Hematol 1976; 2- Champlim et al. Br J Haematol Zoumbos et al. PNAS 1985; 4- Solomou et al. Blood Shi et al. Blood 2012

3 Young, Calado & Scheinberg, Blood 2006

4 Immunosuppressive therapy Corticosteroids ~10% response hatg 40 50% response hatg + CSA 60 70% response Di Bona E et al. Br J Haematol 1999;107: Di Bona E et al. Br J Haematol 1999;107:

5 Absolute lymphocyte count cells/µl Rabbit ATG: profound lymphodepleting 2500 hatg ratg Time (days) Scheinberg P et al. Blood 2007;109: Scheinberg P et al. Blood 2012;119:

6 Sobrevida (%) Horse x rabbit ATG in SAA Hematologic response ATG horse ATG rabbit P- value months (62%) (33%) months (68%) (37%) < ATG horse ATG rabbit Anos horse ATG: higher response and OS gold-standard IST: hatg + Cyclosporine Scheinberg P et al. N Engl J Med 2011

7 Horse x rabbit ATG in SAA Study (year) hatg (N) ratg (N) hatg response (%) ratg response (%) Zheng (2006) 47 (Lympho) 32 (Fr) Atta (2010) 42 (Lympho) Design Prospective, randomized 29 (Thymo) Retrospective Afable (2011) 67 (ATGAM) 20 (Thymo) Retrospective Scheinberg (2011) 60 (ATGAM) 60 (Thymo) Prospective, randomized Marsh (2012) 105 (Lympho) 35 (Thymo) Prospective Shin (2013) 46 (Lympho) 53 (Thymo) Retrospective Yoshimi (2013) 96 (Lympho) 32 (Thymo) Retrospective Vallejo (2015) 62 (Lympho) 162 (Thymo) Retrospective Clé (2018) 85 (Lympho) 170 (Thymo) Retrospective

8 Rabbit ATG: useful in SAA? CSA monotherapy in AA ratg dose LogRank test = mg/kg/d 3.0 mg/kg/d 3.5 mg/kg/d 5.0 mg/kg/d time(days) Number at risk 2.5 mg/kg/d mg/kg/d mg/kg/d Shetty M. et al. J Clin Diag Res 2016 Clé DV. Manuscript in publication

9 Increase immunosuppression intensity? Corticosteroids ~10% response hatg 40 50% response hatg + CSA 60 70% response Adding a third drug

10 Improve immunosuppression? Alemtuzumab: 19% overall response. Early discontinued (toxicity) 3 Cyclophosphamide:. 71% overall response. Fungal infections(21-39%) 4 1- Scheinberg P. et al. Br J Haematol 2006;133(6):606-11; 2-Scheinberg P. et al. Haematologica 2009;94(3):348-54; 3-Scheinberg P. et al. Blood 2012;119(2): ; 4-Brodsky RA. et al. Blood 2010;115(11):

11 Refractoriness 1/3 of patients (2/3 in Brazil) Insufficient Immunosuppression? HSC and progenitor cells exhaustion?

12 Thrombopoietin and hematopoiesis Selfrenewal HSC Multipotent stem cell Primitive progenitor cells CMP SCF TPO IL-7 CLP TPO-R ELTROMBOPAG Committed precursor cells IL-3 SCF TPO GM-CSF MEP GM TNK BCP IL-7 IL-7 Eltrombopag & Transmembrane domain Lineage committed cells MkP TPO TPO EPO EP EPO MP GP TCP NKP M-CSF G-CSF IL-5 SCF IL-7 IL-2 IL-7 IL-2 IL-7 IL-15 IL-15 IL-4 JAK2 kinase Stat RAS/R AF MEK MAPK /ERK Platelets Erythrocytes Monocytes Neutrophils, Eosinophils T cells NK cells B cells De Laval B et al. Cell Stem Cell 2013;12:37 48

13 Eltrombopag + IST: 1 st line hatg Day 1-4 Hematologic response CSA 6 months 3 months 6 months Cohort 1 Cohort 2 Eltrombopag 150 mg Day 14 to 3 months Eltrombopag 150 mg Day 14 to 6 months 5 years follow-up Cohort 3 Eltrombopag 150 mg Day 1 to 6 months Townsley DM et al. N Engl J Med 2017;376:

14 Eltrombopag + IST: 1 st line 3 months Cohort 1 N=30 Cohort 2 N=31 Cohort 3 N=31 OR 23 (77%) 24 (77%) 27 (87%) RC 5 (17%) 8 (26%) 15 (48%) 6 months OR 24 (80%) 27 (87%) 29 (94%) RC 10 (33%) 8 (26%) 18 (58%) 2 years OS: 97% Townsley DM et al. N Engl J Med 2017;376:

15 Eltrombopag + IST: 1 st line 3 months Cohort 1 N=30 Cohort 2 N=31 Cohort 3+ext N=88 OR 23 (77%) 24 (77%) 66 (75%) RC 5 (17%) 8 (26%) 25 (28%) 6 months OR 24 (80%) 27 (87%) 69 (79%) RC 10 (33%) 8 (26%) 38 (44%)

16 RACE study: TPO-R agonists added to standard IST for firstline treatment of patients with SAA Hematologic response at 3 and 6 months hatg 4 days Arm 1 (n=100) Arm 2 (n=100) CSA 12 months Standard IST Standard IST plus eltrombopag 150 mg Day 14 to 3 months 5-year follow-up Primary endpoints: CR rate at 6 months, toxicity (ANC 1 x10 9 /L, hemoglobin 10 g/dl, and platelets 100 x10 9 /L) EudraCT Number: For presentation in response to an unsolicited request for medical information subject to local NP4 approval. Not for distribution

17 SOAR trial: Eltrombopag + CSA in 1 st line FPFV 09/2016 Hematologic response 3 months 6 months 12 months CSA 24 months Eltrombopag 150 mg Day 0 to 6 months 5 years follow-up Primary Endpoints: OR to 6 months Secondary Endpoints: 3 and 12 months OR, survival and safety For presentation in response to an unsolicited request for medical information subject to local NP4 approval. Not CETB115 for 2403 distribution

18 Conclusions Although improvements have been made in IST, approximately one-third of patients (2/3 in Brazil) remains refractory. hatg is superior to ratg in first-line treatment of SAA and must be the gold standard IST. Increased intensity of immunosuppressive therapy has not improved outcomes We probably reached the limit for IST. Eltrombopag has been improving IST outcomes. However, results of ongoing randomized trials comparing IST with and without eltrombopag are pending.

19 For presentation in response to an unsolicited request for medical information subject to local NP4 approval. Not for distribution Rodrigo Calado Guilherme Darrigo Roberto Falcão Belinda Simões Eduardo Rego Fabíola Traina André Pinto Barbara Santana Fernanda Rodriguez Flavia Donaires Florencia Tellechea João Paulo Silva Lilian Figueiredo Phillip Scheinberg Carmem Bonfim Larissa Medeiros Michel Oliveira Ricardo Pasquini Marco Salvino Sara Saad Elvira Velloso Marlene Garanito Elias Atta Carlos Bernardo Lima Patricia Blum Fonseca Thank you

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