Antibodies are a standard part of first relapse management in multiple myeloma (MM): Yes
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1 Antibodies are a standard part of first relapse management in multiple myeloma (MM): Yes Ajay Nooka, MD MPH FACP Assistant Professor, Division of Bone Marrow Transplant Winship Cancer Institute, Emory University 1365 Clifton Road NE, C4010, Atlanta, GA
2 Head to head comparison 2
3 Approach to Treatment of Myeloma Transplant ineligible Transplant eligible Induction treatment (6-8 cycles) Induction Transplant treatment (4-5 Candidate cycles) Stem Cell Transplantation Maintenance? Maintenance? Option for relapsed regimens Option for relapsed regimens 3
4 Lenalidomide and Bortezomib-based early relapse regimens: Phase 3 trials Trial Regimen Primary endpoints Secondary Endpoints ASPIRE 1 N=792 TOURMALINE-MM-1 2 N=722 ELOQUENT-2 3 N=646 POLLUX 4 N=569 PANORAMA 5 N=768 CASTOR 6 N=498 Rd + Carfilzomib PFS OS, ORR, DOR, HR-QOL, Safety Rd Rd + Ixazomib PFS OS, OS in del (17p), ORR, >VGPR, DOR, TTP, TTP in Rd high risk pts, Safety, global health Rd + Elotuzumab PFS, ORR OS, Severity of pain or interference with QOL Rd Exploratory: TTR, DOR, HR-QOL, Safety Rd + Daratumumab PFS TTP, ORR, >VGPR, >CR, MRD, TTR, DOR, OS Rd Vd + Panobinostat PFS OS, ORR, DOR, TTP, Safety Vd Vd + Daratumumab PFS TTP, ORR, >VGPR, DOR, TTR, OS Vd Exploratory: TTNT 1. Stewart K, et al. N Engl J Med. 2015;372(2): Moreau P, et al. N Engl J Med. 2016;374(17): Lonial S, et al. N Engl J Med. 2015;373(7): Dimopoulus M, et al. N Engl J Med. 2016;375(14): San Miguel J, et al. Lancet Oncol. 2014;15(11): Palumbo A, et al. N Engl J Med. 2016;375(17):
5 Variables to consider Survival: PFS and OS Variable Favor antibody Favor non-antibody approaches Efficacy: ORR and Deeper Responses Safety: AE profile Benefit as earlier line of therapy Possibility of delivering uninterrupted therapy over long term Possibility of Retreatment Cost-Effective Score Board 5
6 Lenalidomide and Bortezomib-based early relapse regimens: PFS and OS Trial Regimen PFS (mon) PFS (HR, 95% CI) OS (HR, 95% CI) ASPIRE 1 N=792 TOURMALINE-MM-1 2 N=722 ELOQUENT-2 3 N=646 POLLUX 4 N=569 PANORAMA 5 N=768 CASTOR 6 N=498 Rd + Carfilzomib ( ) Rd 17.6 p= Rd + Ixazomib ( ) Rd 14.7 p=0.01 Rd + Elotuzumab ( ) Rd 14.9 p<0.01 Rd + Daratumumab NR 0.37 ( ) Rd 18.4 P< Vd + Panobinostat ( ) Vd 8.08 P< Vd + Daratumumab NR 0.39 ( ) Vd 7.2 P< ( ) p=0.04 NR 0.78 ( ) 0.63 ( ) 0.87 ( ) P= ( ) 1. Stewart K, et al. N Engl J Med. 2015;372(2): Moreau P, et al. N Engl J Med. 2016;374(17): Lonial S, et al. N Engl J Med. 2015;373(7): Dimopoulus M, et al. N Engl J Med. 2016;375(14): San Miguel J, et al. Lancet Oncol. 2014;15(11): Palumbo A, et al. N Engl J Med. 2016;375(17):
7 Variables to consider Variable Favor antibody Favor non-antibody approaches Survival: PFS and OS 1 0 Efficacy: ORR and Deeper Responses Safety: AE profile Benefit as earlier line of therapy Possibility of delivering uninterrupted therapy over long term Possibility of Retreatment Cost-Effective Score Board 1 0 7
8 Lenalidomide and Bortezomib-based early relapse regimens: Efficacy Trial Regimen ORR (%) VGPR (%) ASPIRE 1 N=792 TOURMALINE-MM-1 2 N=722 ELOQUENT-2 3 N=646 POLLUX 4 N=569 PANORAMA 5 N=768 CASTOR 6 N=498 Rd + Carfilzomib Rd Rd + Ixazomib Rd Rd + Elotuzumab Rd Rd + Daratumumab Rd Vd + Panobinostat Vd Vd + Daratumumab Vd Stewart K, et al. N Engl J Med. 2015;372(2): Moreau P, et al. N Engl J Med. 2016;374(17): Lonial S, et al. N Engl J Med. 2015;373(7): Dimopoulus M, et al. N Engl J Med. 2016;375(14): MRD negative rates: POLLUX 7 5. San Miguel J, et al. Lancet Oncol. 2014;15(11): Palumbo A, et al. N Engl J Med. 2016;375(17): Usmani S, et al. Blood. 2016;128: Abstract
9 Variables to consider Variable Favor antibody Favor non-antibody approaches Survival: PFS and OS 1 0 Efficacy: ORR and Deeper Responses 1 0 Safety: AE profile Benefit as earlier line of therapy Possibility of delivering uninterrupted therapy over long term Possibility of Retreatment Cost-Effective Score Board 2 0 9
10 Lenalidomide and Bortezomib-based early relapse regimens: Safety Trial Regimen G3 AEs (%) Rate of discontinuation due to AE (%) ASPIRE 1 N=792 TOURMALINE-MM-1 2 N=722 ELOQUENT-2 3 N=646 POLLUX 4 N=569 PANORAMA 5 N=768 CASTOR 6 N=498 Rd + Carfilzomib Rd Rd + Ixazomib Rd Rd + Elotuzumab 77 9 Rd Rd + Daratumumab Rd Vd + Panobinostat Vd Vd + Daratumumab Vd No known long term risks with antibodies 1. Stewart K, et al. N Engl J Med. 2015;372(2): Moreau P, et al. N Engl J Med. 2016;374(17): Lonial S, et al. N Engl J Med. 2015;373(7): Dimopoulus M, et al. N Engl J Med. 2016;375(14): San Miguel J, et al. Lancet Oncol. 2014;15(11): Palumbo A, et al. N Engl J Med. 2016;375(17):
11 Variables to consider Variable Favor antibody Favor non-antibody approaches Survival: PFS and OS 1 0 Efficacy: ORR and Deeper Responses 1 0 Safety: AE profile 1 0 Benefit as earlier line of therapy Possibility of delivering uninterrupted therapy over long term Possibility of Retreatment Cost-Effective Score Board
12 Benefit of antibodies as earlier lines of therapy: MRD negativity from CASTOR MRD ve rate with DVd as 1 st line vs ITT PFS with DVd as 1 st line vs 2-3 Mateos MV, et al. Blood. 2016;128: Abstract
13 Variables to consider Variable Favor antibody Favor non-antibody approaches Survival: PFS and OS 1 0 Efficacy: ORR and Deeper Responses 1 0 Safety: AE profile 1 0 Benefit as earlier line of therapy 1 0 Possibility of delivering uninterrupted therapy over long term Possibility of Retreatment Cost-Effective Score Board
14 Relative Benefit of PFS: Possibility of delivering therapy over long term Betts K, et al. Haematologica. 2017;102: Abstract E
15 Variables to consider Variable Favor antibody Favor non-antibody approaches Survival: PFS and OS 1 0 Efficacy: ORR and Deeper Responses 1 0 Safety: AE profile 1 0 Benefit as earlier line of therapy 1 0 Possibility of delivering uninterrupted therapy over long term Possibility of Retreatment Cost-Effective 1 0 Score Board
16 Possibility of Retreatment with antibodies Cohort 1 (n=19) (DARA and POM naïve) Cohort 2 (n=22) (DARA or POM ref) Cohort 3 (n=12) (DARA and POM ref) ORR SCR CR VGPR PR MR/SD PD 17 (89%) 9 (40.9%) 4 (33.3%) 7 (36.8%) 1 (5.3%) 3 (15.8%) 1 (4.5%) 1 (8.3%) 8 (42.1%) 8 (36.4%) 3 (25%) 1 (5.3%) 9 (40.9%) 6 (50%) 1 (5.3%) 4 (18.2%) 2 (16.7%) Median cycles 15 (1-23) 3 (1-8) 3 (1-8) Nooka A, et al. Blood. 2016;128: Abstract
17 Variables to consider Variable Favor antibody Favor non-antibody approaches Survival: PFS and OS 1 0 Efficacy: ORR and Deeper Responses 1 0 Safety: AE profile 1 0 Benefit as earlier line of therapy 1 0 Possibility of delivering uninterrupted therapy over long term 1 0 Possibility of Retreatment 1 0 Cost-Effective and convenience Score Board
18 Cost-effectiveness No formal studies Weekly administration for the first 2 months, biweekly for the next 6 months and monthly administration afterwards Convenient schedule 18
19 Variables to consider Variable Favor antibody Favor non-antibody approaches Survival: PFS and OS 1 0 Efficacy: ORR and Deeper Responses 1 0 Safety: AE profile 1 0 Benefit as earlier line of therapy 1 0 Possibility of delivering uninterrupted therapy over long term 1 0 Possibility of Retreatment 1 0 Cost-Effective and convenience 1 0 Score Board
20 Emory Approach to Early Relapse Slow indolent relapse Aggressive relapse + Len maintenance - Len maintenance + Len maintenance - Len maintenance Consider adding Ixazomib/Dex* Consider Dara/Len/Dex Consider Dara/Pom/Dex Consider Dara/Len/Dex Consider Adding Elo/Dex* * Increase len dose Consider Elo/Len/Dex Consider Car/Len/Dex Consider Car/Pom/Dex Consider Dara/Vel/Dex Consider Car/Pom/Dex Car/Pan as second salvage if IMID used 20
21 Thank you Questions?? P.S: please don t fall for the magic words of JK, data >>> words 21
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