GLSG/OSHO Study Group. Supported by Deutsche Krebshilfe

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1 GLSG/OSHO Study Group Supported by Deutsche Krebshilfe

2 GLSG/OSHO Study Group Study Concepts Follicular Lymphomas Mantel Cell Lymphomas Waldenstroem s Disease

3 Key Steps in Improving Treatment for Follicular Lymphoma Prolongation of Life since mid 1990ies Cure Palliation of Symptomes until mid 1990ies Antibodies ASCT Cytostatic Drugs Radiation

4 Rituximab Chemotherapy Combinations OR PFS OS CVP 64 % 14 mo 83 % R-CVP 87 % (p<0.0001) 38 mo (p<0.001) 89 % (p=0.022) Marcus et al CHOP 90 % 31 mo 90 % R-CHOP 96 % (p=0.011) n.r. (p=0.0006) 95 % (p=0.016) Hiddemann et al MCP 75 % 26 mo 74 % R-MCP 92 % (p=0.0009) n.r. (p<0.0001) 87 % (p=0.0096) Herold et al CHVP+IFN 72 % 35 mo 79 % R-CHVP+IFN 81 % (p<0.0001) n.r. (p<0.0001) 84 % (p=0.029) Salles et al. 2008

5 Time to Treatment Failure

6 Comparison of Two Consecutive Study Generations of the GLSG Overall Survival

7 Future Strategies in Follicular Lymphomas Induction Therapy in Remission Rituximab Maintenance Chemotherapy plus Rituximab => Lymphoma Reduction => Lymphoma Control

8 Follicular Lymphomas Questions for the Next Steps of Therapy Best Chemotherapy to be combined with Rituximab Value of Radio-Immuno Therapy Value of Stem Cell Transplantation after R Chemo Improvement of Rituximab Application Improvement of Rituximab Maintenance New Antibodies New Agents

9 Antibody Therapy for B - Cell Lymphomas CD22 CD25 CD20 slg HLA-DR CD37 Targeting agent Monoclonal antibody Engineered antibody Recombinant toxin CD19 B-CellB CD52 Modifications None Conjugation Radioisotopes Drugs Toxins Adapted from Press. Cancer J Sci Am. 1998;4(suppl 2):S19.

10 GA101 Mechanisms of Action Increased direct cell death Type II vs. Type I antibody Enhanced ADCC Glycoengineering for increased affinity to FcγRIIIa Effector cell B cell Lower CDC activity Type II vs. Type I antibody GA101 CD20 Complement FcγRIIIa 10 *Mössner E, et al. Blood. 2010; June 3; 115: ; Roche data on file

11 GALLIUM Phase III - Study Design Previously untreated indolent NHL (n=1400) GA mg x 6-8 cycles + CHOP/CVP/Bendamustine x 6-8 cycles Rituximab 375 mg/m 2 x 6-8 cycles + CHOP/CVP/Bendamustine x 6-8 cycles CR/PR CR/PR Maintenance GA101 q2m 2 years Maintenance rituximab q2m 2 years Experimental arm GA mg d1, d8, d15 cycle 1; d1 cycles 2 6/8 + CHOP q 21d / CVP q 21 d / Bendamustine 90 mg/m 2 d1, d2 q28d Control arm Rituximab 375 mg/m 2 d1 cycles 1-6/8 + CHOP q 21d / CVP q 21 d / Bendamustine 90 mg/m 2 d1, d2 q28d Patient population Primary endpoint Maintenance treatment 1200 fnhl and 200 MZL PFS of 1200 fnhl patients Patients achieving CR or PR continue therapy every 2 months for up to 2 years Source:

12 GALLIUM Global Recruitment February 2013

13 GALLIUM Recruitment per Country February 2013

14 GALLIUM - Lymphoma Subtypes February 2013

15 GALLIUM - Chemotherapy chosen by Center for FL

16 GALLIUM (BO21223): Timelines for Futility Analysis Futility GALLIUM (BO21223) Phase III G-chemo vs. R-chemo in 1st line inhl w/maintenance L IA data availability FA data availability Futility CR (Feb 13) Futility PFS IA PFS FA (May 15) (Jan 17) (Jun 18) (Nov 19) Futility analysis based on first 170 patients response at end of induction

17 Follicular Lymphomas Questions for the Next Steps of Therapy Best Chemotherapy to be combined with Rituximab Value of Radio-Immuno therapy Value of Stem Cell Transplantation after R Chemo Improvement of Rituximab Application Improvement of Rituximab Maintenance New Antibodies New Agents

18 Lenalidomide Mechanism of Action

19 M.S.1 Lenalidomide plus Rituximab First Line Therapy of Follicular Lymphoma SLL (N=24) Marginal (N=24)* Follicular (N=45)* All Patients Eval (N=93) ITT (N=100) ORR, n (%) 20(83) 21(88) 44(98) 85(91) 85(85) CR/Cru 6(25) 16(67) 38(85) 60(65) 60(60) PR 14(59) 5(21) 6(13) 25(27) 25(25) SD, n (%) 2(8) 3(13) 1(2) 6(6) 6(6) PD, n (%) 2(8) 0 0 2(2) 2(2) Fowler, N. et al. ICML Abst#137.

20 Folie 19 M.S.1 It may be good to include the median follow-up time... Marianna Shafarenko;

21 RELEVANCE : Phase 3 Study Design (Rituximab and LEnalidomide Versus ANy ChEmotherapy, FL-001) International, multi-centre, randomised study CR, CRu, PR 1st line FL n = 1000 R R 2 R-Chemo R 2 Maintenance 2 Years Rituximab Maintenance CR, CRu, PR R 2 Induction Lenalidomide 20 mg d 2-22 for 6 Cycles Ritux 4xCycle 1, 1x Cycles 2-6 R-Chemo R-CHOP (6x), R-CVP (8x), R-B (6x) R 2 maintenance 2 Years of Rituximab Maintenance 1 Year of Lenalidomide Maintenance

22 Therapy of follicular Lymphomas: GLSG/OSHO Gruppe 1 Fit patient Organfunktion Funktioneller Status Lebenserwartung Komorbidität Toxizitätsrisiko GALLIUM Go go Intensive Chemotherapie => anhaltende Remissionen Gruppe 2 Compromised patient Organfunktion Funktioneller Status Lebenserwartung Komorbidität Toxizitätsrisiko Slow go Weniger belastende Chemotherapie => Zurückdrängen des Lymphoms Gruppe 3 Frail patient Organfunktion Funktioneller Status Lebenserwartung Komorbidität Toxizitöätsrisiko No go supportive Therapie => Syptomkontrolle RELEVANCE CHOP/Benda-R CHOP/Benda-G R- Chemo R- 2 Rituximab Maintenance GA 101 Maintenance Rituximab Maintenance R - 2 Maintenance

23 Therapy of follicular Lymphomas: GLSG/OSHO/StiL Gruppe 1 Fit patient Organfunktion Funktioneller Status Lebenserwartung Komorbidität Toxizitätsrisiko Gruppe 2 Compromised patient Organfunktion Funktioneller Status Lebenserwartung Komorbidität Toxizitätsrisiko Gruppe 3 Frail patient Organfunktion Funktioneller Status Lebenserwartung Komorbidität Toxizitöätsrisiko Go go Intensive Chemotherapie => anhaltende Remissionen Slow go Weniger belastende Chemotherapie => Zurückdrängen des Lymphoms No go supportive Therapie => Syptomkontrolle

24

25 Study Design Medically Non-Fit Induction R A N D O M I S A T I O N A B 4 x Rituximab + 1x Rituximab 4x R-Bendamustine + 1 x Rituximab Re- Staging Week 16 CR PR SD CR PR SD Rituximab 375 mg/m² every 8 weeks week 21, 29, 37 Rituximab 375 mg/m² every 8 weeks week 21, 29, 37 Observation Observation PD Off study

26 GLSG/OSHO Study Group Study Concepts Follicular Lymphomas Mantel Cell Lymphomas Waldenstroem s Disease

27 Young Patients (<65) Elderly Patients (>65) Compromised Patients dose-intensified immuno-chemotherapy (either sequential: R-CHOP/R-DHAP =>PBSCT or R-Hyper-CVAD) high tumor load: immuno-chemotherapy (e.g. R-FC) allo-transplant? radioimmunotherapy? Rituximab maintenance? First line treatment conventional immuno-chemotherapy (e.g. R-CHOP) Rituximab maintenance! radioimmunotherapy? 1. relapse immuno-chemotherapy (e.g. R-FC, R-Bendamustin) molecular approaches! autologous PBSCT radioimmunotherapy? Rituximab maintenance? higher relapse watch & wait? Rituximab monotherapy Chlorambucil Bendamustin immunochemotherapy (e.g. R-Bendamustin) molecular approaches molecular approaches: Temsirolimus, Bortezomib, Lenalidomide (preferable in combination) repeat previous therapy (long remissions)

28 European MCL Network Patients <65 Years 3 x R-CHOP 3 x R-CHOP DexaBEAM (stem cell mobilization) Cyclo 120mg/kg + TBI 12 Gray PBSCT PR, CR! PR, CR! 3 x R-CHOP 3 x R-DHAP alternating (stem cell mobilization after course 4) TBI 10 Gray Ara-C 4 x 1.5 g/m 2 Melphalan 140 mg/m 2 PBSCT Hermine, ASH 2012

29 Abort without staging Evaluable MCL Younger Response to Induction R CHOP 3% R DHAP 3% ED 0 0% 0 0% PD 12 5% 8 3% SD 12 5% 6 3% PR % 92 39% CRu 33 14% 42 18% CR 59 25% 89 38% p= CR or CRu 92 39% % p= CR or CRu or PR % % p=0.13

30 MCL younger Time to Treatment Failure Hermine, ASH 2012

31 MCL younger Overall Survival Hermine, ASH 2012

32 Young Patients (<65) Elderly Patients (>65) Compromised Patients dose-intensified immuno-chemotherapy (either sequential: R-CHOP/R-DHAP =>PBSCT or R-Hyper-CVAD) high tumor load: immuno-chemotherapy (e.g. R-FC) allo-transplant? radioimmunotherapy? Rituximab maintenance? First line treatment conventional immuno-chemotherapy (e.g. R-CHOP) Rituximab maintenance! radioimmunotherapy? 1. relapse immuno-chemotherapy (e.g. R-FC, R-Bendamustin) molecular approaches! autologous PBSCT radioimmunotherapy? Rituximab maintenance? higher relapse watch & wait? Rituximab monotherapy Chlorambucil Bendamustin immunochemotherapy (e.g. R-Bendamustin) molecular approaches molecular approaches: Temsirolimus, Bortezomib, Lenalidomide (preferable in combination) repeat previous therapy (long remissions)

33 European MCL Network Patients >60 Years 4 x R-CHOP 3 x R-FC PR, CR 4 x R-CHOP 3 x R-FC IFN-α maintenance (3 x 3 M IU/week) or Peg-IFN (1mg/kg week) PR, CR Rituximab maintenance (all 2 months) Kluin-Nelemans, NEJM 2012

34 MCL Elderly: Response to Induction 3% 8 4% 12 ED 14% 36 6% 15 PD 28% 73 37% 100 PR All R-FC R-CHOP Evaluable % 51% 38% 12% 5% 4% p=0.15 p=0.30 p= % 46% 32% 14% 6% 3% CR/CRu/PR CR/CRu CR CRu SD Premature stop Documented

35 MCL Elderly: Toxicity of Induction Toxicity Hemoglobin Leukocytes Granulocytes Platelets Lymphocytes p < Grade 1/2 3/4 1/2 3/4 1/2 3/4 1/2 3/4 1/2 3/4 R-CHOP (n 261) R-FC (n 272) freq % freq %

36 MCL Elderly Overall survival R-FC R-CHOP Kluin-Nelemans, NEJM 2012

37 European MCL Network Patients >60 Years 4 x R-CHOP 3 x R-FC PR, CR 4 x R-CHOP 3 x R-FC IFN-α maintenance (3 x 3 M IU/week) or Peg-IFN (1mg/kg week) PR, CR Rituximab maintenance (all 2 months) Kluin-Nelemans, ASH 2011

38 MCL Elderly Remission Duration Kluin-Nelemans, NEJM 2012

39 MCL Elderly Response Duration After R-CHOP After R-FC

40 MCL Elderly: Overall Survival After R-CHOP After R-FC p=0.055 for interaction of induction and maintenance Kluin-Nelemans, NEJM 2012

41 European MCL Network: new studies 2013 First line < 65 years > 65 years MCL younger: R-CHOP/DHAP => low risk: ASCT vs. I. high risk: ASCT-> R vs I MCL elderly R2: R-CHOP vs R-CHOP/Ara-C => Rituximab M +/-Lenalidomide MCL elderly I: BR +/- Ibrutinib => Rituximab M +/- Ibrutinib 1. Relapse R-HAD +/- Bortezomib 2. Relapse (or not qualifying for R-HAD) Ibrutinib vs Temsirolimus BeRT BR-Temsirolimus

42 GLSG/OSHO Study Group Follicular Lymphomas Mantel Cell Lymphomas Waldenstroem s Disease

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