Is Transplant a Necessity or a Choice: Focus on the necessity for CR and MRD

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1 Is Transplant a Necessity or a Choice: Focus on the necessity for CR and MRD Ajai Chari, MD Associate Professor of Medicine Director of Clinical Research Multiple Myeloma Program Mount Sinai Medical Center

2 Importance of Response Depth Post ASCT Response Depth by Conventional Criteria ASCT Novel Agent Combinations Response Depth by MRD ASCT Novel Agent + ASCT

3 Response Response Depth: Conventional Stringent CR (scr) Complete Response (CR) Very Good PR (VGPR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) IMWG Criteria M protein % Plasma Cells in BM Skeletal Disease normal FLC ratio AND PEP/IFE negative No clonal PC AND< 5% Stable PEP negative IFE negative < 5% Stable PEP negative but IFE positive < 5% Stable > 50% reduction in SPEP > 90% reduction in UPEP > 50% dec Inv -UnInv FLC N/A Stable Not meeting criteria for scr, CR, VGPR, PR nor PD > 25% increase (SPEP by 0.5, UPEP by 0.2, New bone lesions Inv- UnInv FLC by 10) 25% increase or increased size

4 Depth of Response and Overall Survival After ASCT van de Velde HJ, et al. Haematologica 2007;92(10):

5 Does Depth of Response Matter in Era of Novel Therapies? A1 A2 B1 B2 VAD x 4 VAD x 4 Induction Vel-Dex x 4 Vel-Dex x 4 DCEP x 2 Consolidation DCEP x 2 Transplant 1: melphalan 200 mg/m2 Transplant 2: second ASCT or RIC allo if < VGPR PFS Post ASCT > or < VGPR Moreau P. et al. Blood 2011;117(11):

6 Increasing Rates of CR with Novel Induction Regimens Munshi et al. IMW 2015.

7 Comparison of MRD Techniques Paiva et al. Blood May 14;125(20):

8 Biran B, Ely S, Chari A. Current Hematologic Malignancy Reports Sept.

9 Impact of MRD Status on Survival Outcomes in CR Patients: A Meta-Analysis 9 Number of patients with PFS and OS data allowing for analysis Patients assessed for PFS 496 1, articles retrieved in total Any response-achieving patients (n = 13 studies) 9 MFC, 11 PCR, 1NGS Patients assessed for OS 496 1,329 CR-achieving patients (n = 4 studies) 3 MFC, 1 PCR Munshi et al. IMW ,000 1,500 2,000 Number of patients assessed 1. Paiva B, et al. J Clin Oncol. 2011;29: Paiva B, et al. Blood. 2012;119: Rawstron AC, et al. J Clin Oncol. 2013;31: Swedin A, et al. Br J Haematol. 1998;103:

10 Effect of MRD Status in CR Patients on Risk of Disease Progression 10 N= 496 CR patients, 362 MRD neg, 134 MRD pos MRD-negativity reduced HR of PD by 56% Rawstron et al. 1 Swedin et al. 2 Paiva et al Paiva et al Total Overall HR 0.44 (95% CI ; P < ) The size of the solid squares is proportional to the amount of information each study contains. An open diamond represents the overall result. CI, confidence interval; CR, complete response; HR, hazard ratio; MRD, minimal residual disease. Munshi et al. IMW HR 1. Rawstron AC, et al. J Clin Oncol. 2013;31: Swedin A, et al. Br J Haematol. 1998;103: Paiva B, et al. J Clin Oncol. 2011;29: Paiva B, et al. Blood. 2012;119:

11 Patients (%) 100 Effect of MRD Status in CR Patients on PFS MRD-negative (n = 362) MRD-positive (n = 134) (adjusted) = 35.85; P < PFS (years) No. of patients at risk MRD-negative MRD-positive CR patients MRD-negative MRD-positive Data are adjusted for different proportions of patients being MRD-positive and MRD-negative by study. 3-year PFS: 72% MRD-negative versus 50% MRD-positive patients 5-year PFS: 50% MRD-negative versus 29% MRD-positive patients Median PFS 60 months 36 months Majority of MRD-positive patients progressed by 6 years, whereas nearly 50% of MRD-negative patients remained progression-free CR, complete response; MRD, minimal residual disease; PFS, progression-free survival. Munshi et al. IMW 2015.

12 Effect of MRD Status in Post ASCT CR Patients on Overall Survival 12 MRD-negative status reduced the hazard of death by 53% HR Rawstron et al. 1 Swedin et al. 2 Paiva et al Total Overall HR 0.47 (95% CI ; P = ) The size of the solid squares is proportional to the amount of information each study contains. An open diamond represents the overall result. CI, confidence interval; CR, complete response; HR, hazard ratio; MRD, minimal residual disease; OS, overall survival Rawstron AC, et al. J Clin Oncol. 2013;31: Swedin A, et al. Br J Haematol. 1998;103: Paiva B, et al. Blood. 2012;119: Munshi et al. IMW 2015.

13 Patients (%) Effect of MRD status in Post ASCT CR Patients on Overall Survival MRD-negative (n = 362) MRD-positive (n = 134) CR patients MRD-negative MRD-positive Median OS NR 82 months (adjusted) = 15.06; P < OS (years) No. of patients at risk: MRD-negative MRD-positive Data are adjusted for different proportions of patients being MRD-positive and MRD-negative by study. 3-year OS: 93% MRD-negative versus 79% MRD-positive patients 5-year OS: 78% MRD-negative versus 60% MRD-positive patients CR, complete response; MRD, minimal residual disease; NR, not reached; OS, overall survival.. Munshi et al. IMW 2015.

14 Patients (%) OS for Post ASCT CR Patients by FISH and MRD status Combining UK MRC Myeloma IX 1 with Spanish study 2 data (adjusted) = 31.68; P < Standard FISH + MRD-negative (n = 120) High-risk FISH or MRD-positive (n = 108) High-risk FISH + MRD-positive (n = 13) OS (years) Best OS seen in patients with favorable cytogenetics and MRD negativity CR, complete response; FISH, fluorescent in situ hybridization; MRD, minimal residual disease; OS, overall survival. 1. Rawstron AC, et al. J Clin Oncol. 2013;31: Paiva B, et al. Blood. 2012;119: Munshi et al. IMW 2015.

15 Phase 2 MMRC Study of Extended KRd plus ASCT in Newly Diagnosed MM With deferred ASCT, carfilzomib+ lenalidomide + dexamethasone (KRd) has shown excellent responses in NDMM with unprecedented scr 55% and also 3 year disease control rate of 79% However 45% not scr and 21% relapsed in 3 years even with scrs Hence Extended KRd + ASCT study Jakubowiak A, Blood 2012.

16 KRD + ASCT Study Design N= Ziimmeran T ASCO 2015

17 Ziimmeran T ASCO 2015

18 Ziimmeran T ASCO 2015

19 Unanswered Questions DFCI/IFM results? What is predictive value of MRD independent of GEP defined risk Who should be tested for MRD/what is specificity of MRD testing? MRD Present MRD Absent Conventional Measureable Disease - Yes Residual Disease? Conventional Measureable Disease No MRD positive scr MRD negative scr Best MRD test -? molecular assays of peripheral blood and in PET/MRI negative patients given limitations of single BM sample Impact of new era of MM immunotherapy on MRD? significance of a monoclonal antibody associated CR? exogenous IgG antibodies on IFE role of interference assays, heavy lite Personalized medicine use of MRD to guide treatment intensity?

20 Conclusions Response Depth by Conventional Criteria Depth correlates with OS post ASCT Unprecedented depth with novel agent combinations require improved measures of response depth Response Depth by MRD even stringent CRs with highly active KRd still relapse MRD negativity post ASCT correlates with PFS and OS ASCT + consolidation KRd resulted in the biggest improvements in scr and MRD negativity Transplant is still a necessity to achieve scr and MRD negativity

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