How to incorporate new therapies into the treatment algorithm of patients with mantle cell lymphoma

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1 How to incorporate new therapies into the treatment algorithm of patients with mantle cell lymphoma Dr. Guillermo Rodríguez García Hospital Universitario Virgen Macarena Hospital Universitario Virgen del Rocío Seville

2 Index - INTRODUCTION - FIRST LINE TREATMENT: * Fit patients * Non-Fit patients - REFRACTORY / RELAPSE TREATMENT - TAKE HOME MESSAGES

3 Mantle cell lymphoma Real world data Nordic Lymphoma Group observational study 5 % Years : 1389 patients 3,6% 2,4% 2 : 1 Abrahamsson et al Blood. 2014;124(8):

4 A subgroup of patients with MCL may be SAFELY OBSERVED from diagnosis Asymptomatic patients Non-nodal presentation Nodal low burden Low proliferative rate Abrisqueta et al, Ann Oncol Oct 1;28(10):

5 Treatment FIT PATIENTS (Autologous-SCT) NON- FIT PATIENTS (Comorbidities/Age)

6 Randomized trial INTERFERON vs ASCT after CHOP induction Progression free survival 17 m. 39 months ( CR 46 m. PR 33 m. ) Dreyling et al, Blood :

7 Pretransplant Induction Clinical trial Chemotherapy N RG / RC SG / SLP Geisler (NLG) (2008) Damon (CALGB) (2009) Maxi-CHOP x 3 + HADx 3 + R cycles 4º,5º,6º + AUTO-TPH (BEAM) Rituximab if PCR(+) R-CHOP-Mtx x 2 + VP16-AraC x 1 + CBV x 1 + AUTO-TPH + Rituximab x % / 54% 70% / 66% at 6 years 78 88% /69% 64% / 56% at 5 years Delarue (GELA) (2013) R-CHOP x 3 + R-DHAP x 3 + AUTO-TPH 60 82% / 78% 75% / 64% at 5 years - ALL seem to have SIMILAR TOXICITY (high, mainly Hematologic) and OUTCOME (1) - HyperCVAD-R probably is the most effective induction regimen (2), but toxicity seems to be higher (3) and is associated with higher rates of hematopoietic progenitor cell mobilization failure despite Plerixafor rescue (4) - BENDAMUSTINE-R could be a good induction regimen (5) (1) Bude et al, JCO 2011;29: (2) Romaguera et al JCO 23: (3) Merli et al British Journal H 56, (4) Salhotra et al, BBMT 23 (2017) (5) Chen et al BJH 2017, 176(5),

8 Autologous SCT Clinical Trials After CHOP: INTERFERON AUTO-SCT PreAUTO-SCT CHOP CHOP/DHAP PostAUTO-SCT Watch - Wait Consensus EBMT / European MCL Network INDUCTION must include CYTARABINE and RITUXIMAB Consolidate ALL candidates with AUTOLOGOUS Stem Cell Transplantation Robinson et al, Leukemia (2015) 29,

9 Hermine et al, 2016 PFS 5 years median PFS R-CHOP x 6 R-CHOP x 3 / DHAP-R x 3 AUTO - SCT AUTO - SCT n = 234 n = 232 Follow up 6 years 44 % 65 % 4,3 years 9,1 years No difference in OVERALL SURVIVAL Similar Bone Marrow Transplant-related Mortality > GRADE 3-4 TOXICITY with DHAP-R: Mainly Hematologic 65 % 4,3 y 9,1 y. 40 %

10 DHAP-R x 4 AUTO-TPH n = 299 n = 257 R n = 120 Observation n = 120 Follow up 4 years PFS: 83% OS: 89% PFS: 64% OS: 80% Progression-free Survival Overall Survival N Engl J Med 2017;377:

11 Treatment for FIT patients Hiper-CVAD MTX-AraC-R CALGB regimen Maxi-CHOP AraC-R CHOP-R DHAP-R AUTOLOGOUS SCT

12 NON-FIT PATIENTS (Comorbidities/Age)

13 1º Line Randomized Clinical Trials Overall Survival TTF PFS FCM FCM CHOP CHOP > OR > CR > TTF FC CHOP y INTERF V CHOP -CAP BENDA CHOP INCOMPLETE DATA SAFETY WARNING MAINTENANCE NECCESARY? FCM vs FCM-R. Forstpointner et al, Blood. 2004;104: CHOP vs CHOP-R. Lenz et al, J Clin Oncol 23: CHOP-R vs FC-R +/- R Kluin-N et al, N Engl J Med 2012;367: CHOP-R vs BENDA-R Rummel et al, Lancet 2013; 381: CHOP-R vs VR-CAP Robak et al, N Engl J Med 2015;372:944-53

14 Bendamustine results in 1º line Rm 2013 R- BENDA R-CHOP Phase 3 NO INFERIORITY Trial. INDOLENT lymphomas and MCL (n 541 patients) MANTLE CELL LYMPHOMA: 94 / 541 patients PFS TOXIC EFFECTS: - Less INFECTIONS - Less Peripheral neuropathy - Less Stomatitis, etc. 22,1 months 35,4 months Conclusion: Bendamustine plus rituximab can be considered as a preferred first-line treatment approach to R-CHOP CHOP-R vs BENDA-R Rummel et al, Lancet 2013; 381:

15 BENDA CHOP CVP R O R O R O MORTALITY TRIAL NOT DESIGNED to detect DIFFERENCES between the 3 chemotherapy INDUCTION regiments. Marcus et al, N Engl J Med 2017;377:

16 Cross study comparison Number of patients (n) Rate of randomized patients Stil NHL n = 122 (of 168) 73% Kluin-Nelemans et al n = 184 (of 280) 66% Remission duration B - R B R + R CHOP- R CHOP-R + R Median (months) since randomization Rate at 72 months (estimated) n.y.r. 49% 40% 12% 50% Overall Survival Median (months) since randomization Rate at 72 months (estimated) n.y.r n.y.r 64 n.y.r. 70% 66% 50% 71% After a median observation time of 4.5 years, the results are yet inconclusive Simon Rule, ASH 2016

17 R - CHOP vs R - CAP CFM ADR PRED RITUX Each 21 days 14,4 m (1) Inv: 16,1 m Inv: 30,7 m 24,7 m (1) 487 patients randomized (NO AUTO-SCT candidates) Median follow up 40 months (1) Investigator assestment: 30,7 vs 16,1 months Robak et al, N Engl J Med 2015;372:944-53

18 R-CHOP n 244 V R-CAP n 243 CR 42 % (p=0,007) CR 53 % PR 42 % PR 38 % Increased Hematologic Toxicity CHOP-R VR-CAP Platelets transfusion 3 % 23 % Grade 3 Neutropenia 67 % 85 % Grade 3 Infeccion 14 % 21 % MORE DAYS IN HOSPITAL TREATMENT Robak et al, N Engl J Med 2015;372:944-53

19 Untreated Patients 120 MEDIAN PROGRESSION FREE SURVIVAL (months) HD-ARA-C + AUTO-SCT CHOP +/- + AUTO-SCT CHOP +/- V IS IT POSSIBLE TO IMPROVE THIS RESULTS WIH BAC 500 OR LENALIDOMIDE? - CAP BENDA CHOP

20 Bendamustine results in 1º line Visco 2017 BENDA-R + ARA-C 500 (R-BAC500) MANTLE CELL LYMPHOMA: 57 patients COMPLETE REMISSION 91%, PROGRESSION 4%, Toxicity 5%. PROGRESSION FREE SURVIVAL at 35 months: 76% R-BAC500, Visco et al Lancet Haematol 2017; 4: e15 23

21 + 9 cycles Maintenance 36 cycles Phase 2. n = 38 patients Median follow-up: 30 months 85% ORR 92% (CR 64%) Grade 3 4 Adverse Events - Neutropenia (50%) - Rash (29%) - Thrombocytopenia (13%) - Anemia (11%) - Tumor flare (11%) - Fatigue (8%) months Ruan et al, N Engl J Med 2015;373:

22 Treatment V R-CAP CHOP-R BENDA-R RELAPSE

23 REFRACTORY / RELAPSE MCL

24 Chemo-Immunotherapy (R/R) Treatment n Previous Lines OR / RC (%) Median response duration Progression Free Survival BENDA-R (Phase III) Rummel et al (2016) / ,6 months GemOx-Rituximab Obrador-Hevia et al (2016) % (RC 60%) months EPOCH-Rituximab Jermann et al (2004) % (RC 28%) months HiperCVAD-R Romaguera et al (2005) % (RC 43%) months Rummel et al (2016) Lancet Oncol 2016; 17: Obrador-Hevia et al (2016) Br J Haematol Sep;174(6): Jernmann et al (2004) Ann Oncol Mar;15(3):511-6 Romaguera et al (2005) ASH Annual Meeting Abstracts; 106 [abstract 2446]

25 Old New Drugs for Relapse / Refractory n = 155 PT : 1-2 n = 54 PT : 3-4 n = 69 PT : 2-3 CR 8 % PR 25 % CR 1 % PR 20 % CR 18 % PR 41 % BORTEZOMIB TEMSIROLIMUS TEMSIROLIMUS DOR : 9,2 months PFS : 6,2 months DOR : 7,1 months PFS : 4,8 months DOR : 11 months PFS : --- months BORTEZOMIB - GEMCITABINE BORTEZOMIB - - DXM BORTEZOMIB - CHOP

26 New Drugs for Relapse / Refractory LENALIDOMIDE + / - RITUXIMAB IBRUTINIB + / - RITUXIMAB

27 Lenalidomide (R/R) More than 400 MCL included in clinical trial Good Toxicity profile. Median time to response : 2 MONTHS. TRIALS OR (%) CR/CRu (%) R. duration months Median PFS months NHL-002 (N = 15) 53 % 20 % NR NR NHL-003 (N = 57) 35 % 12 % 16.3 m 8.8 m MCL-001 (N = 134) 28 % 7% 16.6 m 4.0 m MCL-002 (N = 170) 40 % 5 % 16.1 m 8.7 m NHL-002: Wiernik et al, Journal of Clinical Oncology, 2008,26, NHL-003: Witzig et al, Annals of Oncology 22: , MCL-001 (EMERGE TRIAL): Goy et al, Journal of Clinical Oncology 31, 2013, MCL-002 (SPRINTTRIAL): Trněny, et al, Lancet Oncol 2016; 17:

28 Wang et al. UNTIL PROGRESSION Previous lines: 2 Phase 1 MTD : 20 mgrs/day Phase 2 (n=44) : ORR 57% (CR 36%, PR 21%) 19 months 11 months Wang et al, Lancet Oncol 2012; 13:

29 n = 111 patients Median previous lines: mgrs daily ORAL. CR 21 % PR 47 % Median response duration: 17 months Median time to response : 2 months Wang et al, N Engl J Med 2013;369:507-16

30 Median previous lines: 2 Median follow up: 20 months 6.2 months 14.6 months Wang patients. Median previous lines: 3 ORR: 88% (44% CR. 44% PR).

31 Refractory / Relapse MCL MEDIAN PROGRESSION FREE SURVIVAL (months) First Line 2º-3º Line 4º Line V - CAP BENDA CHOP BENDAMUSTINE GemOx EPOCH HiperCVAD IBRUTINIB LENALIDOMIDE IBRUTINIB LENALIDOMIDE TEMSIROLIMUS BORTEZOMIB TEMSIROLIMUS

32 Allogeneic Stem Cell Transplantation 2611 CIBMTR patients (62% non myeloablative) 500 MANTLE CELL LYMPHOMA. UNIQUE POTENTIALLY CURATIVE THERAPY ( 35 65% ) Urbano-Ispizua et al. Biol Blood Marrow Transplant Oct;21(10):

33 Take Home Messages - Fit patients treatment should include rituximab, cytarabine, autologous stem cell transplantation and rituximab maintenance. - There is no Gold Standard treatment for Unfit patients: R-CHOP with maintenance VR-CAP, probably with maintenance Bendamustine-R, probably without maintenance Promising results from R-BAC and Lenalidomide-Rituximab regimens - Relapsed/refractory: Immunochemotherapy (Bendamustine-R, GemOx-R, etc) IBRUTINIB +/- Rituximab Lenalidomide - Rituximab

34 Take Home Messages New therapies are NOW improving life expectancy and quality of live of this patients

35 THANK YOU FOR YOUR ATTENTION

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