Treatment of elderly multiple myeloma patients

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1 SAMO Interdisciplinary Workshop on Myeloma March 30 th -31 st 2012, Seehotel Hermitage, Lucerne Treatment of elderly multiple myeloma patients Federica Cavallo, MD, PhD Federica Cavallo, MD, PhD Division of Hematology University of Torino Torino, Italy

2 Median age at diagnosis: 69.4 years

3 OS From Time of Diagnosis in 6-yr Intervals Based on Date of Diagnosis Kumar SK, et al. Blood. 2008;111:

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7 CR rate reliable end point?

8 Efficacy is increased in combination Data from the relapsed/refractory setting Single agent + Dex + Chemotherapy ncr PR ncr PR ncr PR Thalidomide % 25 30% n/a 41 65% 5 26% 41 79% Lenalidomide 2-5 2% 26% 15% (CR) 61% 36 43%* 73 82% Bortezomib % 43% 22% 67% 13 54% 66 85% * VGPR * VGPR 1. Palumbo et al. Blood : Richardson et al. Blood 2009;114: Dimopoulos et al. Leukemia 2009;23: Palumbo et al. ASH 2008 (abstract 868) 5. Knop et al. Blood 2009;113: Richardson et al. Blood 2007;110: Mikhael et al. Br J Haematol 2009;144: Terpos et al. Leukemia 2008; 22(12): Kropff et al. Br J Haematol 2007;138: Popat et al. Br J Haem 2009; 144(6): Reece et al. J Clin Oncol 2008; 26(29):

9 Effective combinations in front-line Combinations investigated in phase 3 trials MPT 1-6 VMP 7,8 VMP-VT 9 VMPT-VT 10 MPR-R 11 Rd 12 1 Palumbo et al. Blood 2008; 112: Facon et al. Lancet 2007; 370: Hulin et al. J Clin Oncol 2009; 27: Waage et al. Blood 2010; 116: Wijermans et al. J Clin Oncol 2010; 28: Beksac et al. Eur J Haematol 2011;86: San Miguel et al. N Engl J Med 2008; 359(9): ; Suppl. App. 8 San Miguel et al. ASH 2011 (Abstract 476), oral presentation 9 Mateos et al. Lancet Oncol 2010; 11(10): Palumbo et al. ASH 2010 (Abstract 620), oral presentation 11 Palumbo et al. ASH 2010 (Abstract 622), oral presentation 12 Rajkumar et al. Lancet Oncol. 2010;11(1):29-37

10 Substantial improvements in PFS and OS with novel agent combinations in non-transplant setting Results from phase 3 trials Median PFS (months) MP MPT VMP 8,9, MPR-R N/A Median OS (months) VMP-VT/VP % (3-yr OS)* VMPT-VT % (3-yr OS)* 1 MTCG. J Clin Oncol 1998;16(12): Palumbo et al. Blood 2008; 112: Facon et al. Lancet 2007; 370: Hulin et al. J Clin Oncol 2009; 27: Waage et al. Blood 2010; 116: Wijermans et al. J Clin Oncol 2010; 28: Beksac et al. Eur J Haematol 2011;86: San Miguel et al. N Engl J Med 2008; 359(9): ; Suppl. App. 9 San Miguel et al. ASH 2011 (Abstract 476), oral presentation 10 Palumbo et al. ASH 2010 (Abstract 622), oral presentation 11 Mateos et al. Lancet Oncol 2010; 11(10): Palumbo et al. ASH 2010 (Abstract 620), oral presentation

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14 Best response rate VMP (N=253) VMPT-VT (N=250) P value CR 24% 42% < > VGPR 50% 64% > PR 81% 90% % of patients VMP 17 % of patients VMPT VT 5 0 CR VGPR PR SD 1 PD CR VGPR PR SD PD

15 Bortezomib-Melphalan-Prednisone-Thalidomide Time to first response and time to CR 100 VMP VMPT VT PR: VMPT VT % of pat tients PR: VMP CR: VMPT VT CR: VMP Months Palumbo et al. JCO. 2010; [Epub ahead of print]

16 Phase 1/2: bortezomib, lenalidomide, dex (VRD) in newly diagnosed MM Treatment Up to 8 3-week cycles: Bortezomib, lenalidomide, dex + maintenance or ASCT Results Response after 4 cycles: ncr 6%, VGPR 11% Best response to treatment (median 10 cycles of treatment) All pts (n=66) Phase 2 population (n=35) CR 29% 37% ncr 39% 57% VGPR 67% 74% PR 100% 100% Median follow-up: 21 months Median PFS & OS not reached 18-months PFS 75% 18-month OS 97% Most common AEs: Sensory PN (80%), fatigue (64%), constipation (61%) Grade 3 PN: 7%, no grade 4 Overall rate of DVT/PE: 6% No treatment-related mortality Richardson et al. Blood 2010;116:

17 Improvement in survival not only in young, but also elderly patients Beneficial effect of novel agents becoming apparent across the whole patient population Pulte et al. The Oncologist 2011;16:

18 Is maintenance reliable end point?

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20 VMPT 1.00 CR VMPT-VT Landmark Analysis (TTP) ISS I and II VT Continuous Therapy VMPT VT Continuous Therapy VMPT-VT 0.75 VMPT-VT 0.50 VMP VMP 0.00 HR 0.54, p= HR 0.45, p= Months Months 1.00 No CR 1.00 ISS III VMPT-VT 0.50 VMPT-VT VMP 0.00 HR 0.63, p=0.25 VMP 0.00 HR 0.63, p= Months Months

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23 Impact of prolonged therapy Lenalidomide maintenance Non-transplant setting - MPR-R superior to MP in terms of PFS 1 Bortezomib maintenance Non-transplant setting - Improvement in PFS (VMPT-VT vs VMP) 2 1 Palumbo et al. ASH 2011 (Abstract 475), oral presentation 2 Palumbo et al. ASH 2010 (Abstract 620)

24 Tolerability of long-term treatment Important to establish long-term tolerability to assess impact on QoL Only few QoL data Thal/pred maintenance post-asct associated with diminished QoL in NCIC CTG MY.10 trial 1 1. Stewart et al. ASH 2010 (Abstract 39)

25 Retreatment with IMiDs Retrospective study Median of 2 treatments prior to IMiD based salvage therapy Median time from diagnosis to repeat exposure to IMiD: 28 months n=140 Len Len n=48 Len Thal n=11 Thal Len n=58 Thal Thal n=23 ORR ( PR) to repeat IMiD therapy Median TTP from start of repeat IMiD therapy 54% 20% 48% 30% 16 months 3 months 9 months 6 months Repeat therapy with IMiDs feasible Response rates with lenalidomide retreatment higher than with repeat thal administration Madan et al. IMW 2011 (abstract P-134); poster presentation Madan et al. Blood 2011;118(7):1763-5

26 Phase 3 VISTA trial: VMP vs MP Subsequent therapies Subsequent therapy and responses achieved VMP (n=215) MP (n=246) Bortezomib-based therapy n=77 n=145 Retreatment PR 50% 58% Thalidomide-based therapy n=103 n=122 PR 46% 55% Lenalidomide-based therapy n=84 n=63 PR 62% 56% Patients can be successfully treated with subsequent IMiD-based therapy and can also be retreated with bortezomib San Miguel et al. ASH 2011 (Abstract 476), oral presentation

27 MM-015: Sensitivity Analysis Effect of SPM on PFS PFS (Disease progression or death as event) EFS (Disease progression, death, or SPM as event) 100 MPR+R 31 months MPR 14 months 100 MPR+R 29 months MPR 15 months MP 13 months MP 13 months Pa atients (%) HR P <.001 HR P < Time (months) HR P <.001 HR P < Time (months) 50 Risk of death or disease progression at 2 years: MPR-R: 45%; MP, 81% Risk of SPM at 2 years: MPR-R: 3%; MP, 2%

28 Risk for SPM vs PD/Death (Safety Population) 100 MPR-R MPR MP Patien nts (%) Time (Months) Time (Months) Time (Months) PD/Death Hematologic SPM Solid Tumor MP, melphalan, prednisone; MPR, melphalan, prednisone, lenalidomide; MPR-R, melphalan, prednisone, lenalidomide with lenalidomide maintenance; PD, progressive disease.

29 What about the frail population?

30 Multiple Myeloma: elderly patients Excellent results obtained in clinical trials using new drugs: MPT, MPV, MPVT-VT, MPR-R Poor results obtained in study population moderate improvement in the age group 60 to 69 years, and no improvement among older patients (Brenner H, et al. Blood. 2008;111: )

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32 Multiple Myeloma: elderly patients Excellent results obtained in clinical trials using new drugs: MPT, MPV, MPVT-VT, MPR-R Poor results obtained in study population Increased toxicity in elderly (unfit) patients

33 MPT and VMP Severe AEs and early discontinuation ITT Doses Grade 3-4 AEs Early Discontinuation MPT 1 Thalidomide 400 mg/d 50% 45% MPT 2 Thalidomide 100 mg/d 50% 41% VMP 3 Bortezomib 1.3mg/m 2 d1,4,8,11 91% 34% 1. Facon T, et al. Lancet. 2007; 370: Palumbo A, et al. Lancet. 2006;367: San Miguel J, et al. N Engl J Med. 2008;359:

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37 Extensive experience in the management of novel agents

38 Extensive experience in the management of novel agents How to manage neutropenia in MM Palumbo A, et al. Clin Lymphoma Myeloma Leuk 2011 Dec 15 [Epub] Management of treatment-emergent peripheral neuropathy in MM Richardson PG, et al. Leukemia 2011 Dec 23 [Epub] Treatment-related peripheral neuropathy in MM: the challenge continues Delforge M, et al. Lancet Oncol 2010;11(11): Optimizing the use of lenalidomide in relapsed or refractory MM: consensus statement Dimopoulos MA, et al. Leukemia 2011;25(5): Consensus guidelines for the optimal management of adverse events in newly diagnosed, transplant-ineligible patients receiving MPT for the treatment of MM Palumbo A, et al. Ann Hematol 2010;89(8): Characterization of haematological parameters with VMP versus MP in newly diagnosed MM, with evaluation of long-term outcomes and risk of thromboembolic events with use of erythropoiesis-stimulating agents: analysis of the VISTA trial Richardson P, et al. Br J Haematol 2011 Mar 6 [Epub]

39 Dose adjustment recommendations for the treatment of frail elderly patients Agent Dose level 0 Dose level 1 Dose level 2 Bortezomib 1.3 mg/m 2 twice / week d 1,4,8,11 / 3 wks 1.3 mg/m 2 once / week d 1,8,15,22 / 5 weeks 1.0 mg/m 2 once / week d 1,8,15,22 / 5 weeks Thalidomide 100 mg/d 50 mg/d 50 mg qod Lenalidomide 25 mg/d 15 mg/d 10 mg/d d 1-21 / 4 weeks d 1-21 / 4 weeks d 1-21 / 4 weeks Dexamethasone 40 mg/d d 1,8,15,22 / 4 week 20 mg/d d 1,8,15,22 / 4 week 10 mg/d d 1,8,15,22 / 4 week Melphalan 0.25 mg/kg d 1-4 / 4-6 weeks 0.18 mg/kg d 1-4 / 4-6 weeks 0.13 mg/kg d 1-4 / 4-6 weeks Prednisone 50 mg qod 25 mg qod 12.5 mg qod Cyclophosphamide 100 mg/d d 1-21 / 4 weeks 50 mg/d d 1-21 / 4 weeks 50 mg qod d 1-21 / 4 weeks Adapted from: Palumbo et al. N Engl J Med 2011;364(11):

40 Overview of VMP schedules: twice-weekly versus once-weekly bortezomib dosing Study Treatment duration Dosing Planned bortezomib dose Delivered bortezomib dose VISTA: VMP 4 twice-weekly 6-week cycles + 5 once-weekly 6-week cycles Bortezomib 1.3 mg/m 2 Melphalan 9 mg/m 2 Prednisone 60 mg/m mg/m mg/m 2 GIMEMA: VMP PETHEMA/ GEM: VMP Modified VISTA schedules: once weekly bortezomib 9 once-weekly 5-week cycles 1 twice-weekly 6-week cycle + 5 once-weekly 5-week cycles Bortezomib 1.3 mg/m 2 Melphalan 9 mg/m 2 Prednisone 60 mg/m 2 Bortezomib 1.3 mg/m 2 Melphalan 9 mg/m 2 Prednisone 60 mg/m mg/m mg/m mg/m 2 n/a San Miguel et al. N Engl J Med 2008;359: Bringhen et al. Blood 2010;116: Mateos et al. Lancet Oncol 2010;11:934-41

41 Conclusions Availability of highly effective combinations incorporating novel agents Unprecedented results without use of transplant Feasibility of rechallenge after upfront novel agent use Extensive experience in the management of novel agents enables optimal delivery of therapy

42 In the future Future trials focused on optimizing MM treatment regimens for both fit and unfit elderly adults are urgently needed to define tailored, personalized therapy for this large patient population.

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