Current Status of Haploidentical Hematopoietic Stem Cell Transplantation

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1 Current Status of Haploidentical Hematopoietic Stem Cell Transplantation Annalisa Ruggeri, MD, PhD Hematology and BMT Unit Hôpital Saint Antoine, Paris, France #EBMTITC16

2 Hematopoietic SCT in Europe: data and trends in 2014 No. of HaploSCT are constantly increasing: 15.6% of allosct are mismatched related; overall 2,456 Haplo SCT (Adults-1,957; Pediatrics 499) 25% increase in HaploSCT in 2014 vs to 2013 No. of transplants No. of teams 40,829 SCT; 15,765 allosct (43%); 20,704 autosct (57%) Compared to % increase in allosct for AML CR1 Main indication for SCT is Leukemias: 11,853 (33% of total, 96% allo) Passweg JR et al, BMT 2015

3 Haploidentical Transplants Platforms T cell depletion (Perugia experience) Infusion of mega-dose CD34 (>10 x 10 6 /kg) Absence of GVHD Low relapse rates (NK KIR alloreactivity) High TRM attributed to slow immune reconstitution New strategies with depletion of αβ+t and B+ cells (Germany- Italy)

4 NON T CELL DEPLETED HAPLO

5 Non T cell depleted - John Hopkins approach Haploidentical Transplants Platforms RIC or MAC BM with post CY - Chinese approach / Italian approach Mobilized bone marrow with high number of IST drugs (TBF- Primed BM- ATG + MTX + CSA +MMF +Basiliximab) - Modified Hopkins approach TBF or FluTBI- BM+ CSA + MMF+CTX (+3, +5) TreoFlu- PBSC-ATG+MMF+Rapamycine+CTX

6 BBMT 14: , 2008

7 Selective allodepletion with PT/Cy Day 0 Day +2 Proliferating ALLOREACTIVE cells are killed Donor and recipient anti-cmv anti-hsv T regs ( ALDH) Lymphs show heterogeneous ALDH1 expression Most T cells, esp. those proliferating, express low levels of ALDH1 and are sensitive to Cy anti-infectious immunity anti-tumour immunity Memory T cells, like other stem -like cells, express high levels and are resistant to Cy Kanakry, et al. Sci Transl Med 2013, Luznik and Fuchs. Immunol Res Non-proliferating non-alloreactive cells are spared

8 Increasing HLA mismatch Improved EFS without GVHD HR = 0.8 Conclusion: It is not necessary to select the donor with the minimum HLA mismatch to the recipient Kasamon, BBMT 16: , 2010

9 Stem cell source in Haplo-SCT

10 Stem cell source in Haplo-SCT Since the early 2000s, BM was the stem cell source commonly reported in the non TCD haplo PBSC is more frequently used in single center, with a reported incidence of agvhd ranging from 30%-40% Registry based study reports a higher incidence of grade II-IV agvhd with no difference in cgvhd, NRM, relapse, LFS for PBSC compared to BM

11 BM or PBSC in RIC-Haplo 86 patients transplanted for hematological malignancies Hopkins regimen with fludarabine 150 mg/m 2, cyclophosphamide 29 mg/kg and 200cGy TBI GvHD prophylaxis: PT-Cy 50 mg/kg days +3 and +4 plus tacrolimus (target level 5-10 ng/ml) or CSA (target level ng/ml) and MMF O Donnell et al, BMT 2016

12 BM or PBSC in RIC-Haplo No significant difference in the rate or global severity of grade II-IV agvhd (33% and 40%, p=0.50) and chronic GvHD after haplo-bm or haplo-pb transplantation (21% and 14%, p=0.39) No difference in NRM Lower relapse (49% vs 20% at 1 year) after PB Comparable overall survival after transplantation of haplo-bm and haplo-pb O Donnell et al, BMT 2016

13 Immune recovery and early complication after Haplo-SCT

14 Immune recovery and early complication after Haplo-SCT T cell deficiency after HSCT remains an issue 1-2 years posttransplant, this will cause increase in risk of infectious complications, especially viral and fungal infections, as well as risk of relapse of disease It has been shown that recovery of T cell function in younger patients is faster than in older patients; this was probably a result of thymic dysfunction in aging population

15 Immune recovery and early complication after Haplo-SCT Other factors associated with thymic dysfunction include: conditioning (i.e. chemotherapy, TBI and the use of antibodies) and GvHD In Haplo SCT, regardless the type of conditioning regimen or the stem cell source used, viral infections range from 40% to 70%, in single center studies Di Bartolomeo, Blood 2013; Raiola BBMT 2013

16 CI hemorrhagic cystitis in unmanipulated haplo recipients, n=33 Probability of OS in unmanipulated haplo recipients 62% [95% CI:42-76] 1 year OS: 50% Grade II-IV acute GVHD was not associated with HC (p=0.62). The occurrence of HC did not impact on OS (p=0.29). Ruggeri, TID, 2015

17 Conclusion CD4+ and CD8+ T-cell early recovery is delayed after Haplo using ATG or PTCy Depletion of Ki-67+ effector/memory cells by PTCy may deplete some pathogen-specific clones and increase the risk of post-transplant infectious complications Strategies to spare non- alloreactive donor nai ve and memory T cells, both to guarantee primary responses to newly encountered antigens and to confer adoptive immunity to Haplo recipient are needed

18 Comparison of outcomes after haplo and matched related or unrelated donor stem cell transplantation

19 J Clin Oncol 2013, 31: NRM Relapse OS DFS

20 Blood 2014 N=305: 90 MSD- 116, UD (33 were 9/10)- 99, Haplo BuCy Cimustine AraC based regimen + ATG CSA, MMF and MTX for Haplo

21 BBMT 2014 N=459: 176 MSD- 86, UD (43 were 9/10)- 105, CBT - 92, Haplo TBF or BuCy as MAC regimen, low dose TBI for RIC + CSA, MMF and ptcy for Haplo Low incidence of acute and cgvhd for Haplo and UCBT recipients

22 Survival after Haplo-identical Related Compared with Matched Unrelated Donor Transplantation for Acute Myeloid Leukemia Stefan O. Ciurea, Mei-Jie Zhang, Andrea Bacigalupo, Asad Bashey, Fredrick R. Appelbaum, Joseph H. Antin, Junfang Chen, Steve Devine, Daniel Fowler, Ryotaro Nakamura, Miguel-Angel Perales, Ravi Pingali, David Potter, Olle Ringden, Vanderson Rocha, Ravi Vij, Daniel J. Weisdorf, Richard E. Champlin, Ephraim Fuchs, Mary Eapen Included are 2174 patients with AML aged years and transplanted between 2009 and Cox regression models were built for recipients of myeloablative conditioning (MAC) (N=1245 MUD compared with N=104 haplo-identical) and reduced intensity conditioning (RIC) (N=737 MUD compared with 88 haplo-identical) transplants. Primary endpoint was 2-year overall survival. Outcomes Transplant Conditioning Regimen Intensity Myeloablative Hazard Ratio Reduced intensity Hazard Ratio NRM Haplo-identical MUD 1.07; p= ; p=0.03 Relapse Haplo-identical MUD 0.88; p= ; p=0.09 Survival Haplo-identical MUD 0.93; p= , p=0.46 Blood 2015

23 Probability, % Leukemia Free Survival Adjusted for DRI, performance score, secondary AML 100 Myeloablative Reduced Intensity MUD 42% (40-45) MUD 37% (33-40) HAPLO 41% (32-51) HAPLO 35% (25-45) HR 0.98 (95% CI ), p=0.87 HR 0.98 (95% CI ), p= Years Years 0

24 Haplo vs UCBT A prospective randomized trial is currently ongoing in North America comparing unmanipulated Haplo and double UCBT in the RIC setting with TBI Cy Flu as conditioning regimen and PTCy as GvHD prophylaxis for Haploidentical Tx RESULTS EXPECTED IN 2019

25 Leukemia doi: /leu ; accepted article preview online April 17, 2015

26 Selection criteria Adults with acute leukemia Transplanted in EBMT centers ( ) Single CBT (TNC at freezing>=2.5x10 7 /Kg) or Double CBT or HaploSCT ( >= 2 HLA MM) Myeloablative or reduced intensity conditioning regimen First allosct 518 non TCD Haplo and 928 CBT

27 Results- UCBT vs Haplo for adults with AL- Neutrophil Engraftment 92±2% 84±2% Median time to engraftment: 17 days for HaploSCT and 23 days for CBT, p=0,003 p<0,001

28 UCBT vs Haplo for adults with AML 29%±5 41%±5 p= %±4 p= %±4 30%±5 38%±4 27%±5 p= 0.35 p= %±5

29 UCBT vs Haplo for adults with ALL p= %±5 p= %±5 25%±4 27%±4 p= %±5 p= %±4 35%±5 28%±5

30 Current status of Haplo- Conclusions 15.6% of allosct in Europe are mismatch related (constantly increasing 25% increase in 2014 vs. 2013) 2456 mismatch related allosct were performed in Europe in 2014 Disease status is one of the main prognostic factor for outcomes Need for the development of transplant strategies in advanced phase AL: Sequential approach combined with post-transplant immuno-intervention Similar results with the use of BM or PBSC and RIC or MAC Higher relapse risk with RIC Number of HLA mismatches does not influence Haplo outcomes

31 Current status of Haplo- Conclusions II DLI administration after Haplo is feasible with no severe toxicities Delayed immune reconstitution and infectious complications are reported Single centers and registry based studies report comparable results between Haplo, sibling donor and unrelated donors Strategies to enhance immunerecovery after Haplo are needed Center experience and policy

32 Acknowledgment ALL EBMT centers ALWP EBMT office Myriam Labopin, Simona Piemontese, Francesca Lorentino, Fabio Ciceri, Mohamad Mohty, Arnon Nagler Emanuelle Polge and all ALWP study coordinators

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