• • • • •
(+) (+) ( – )
• “ ” – – –
2012 ASH Abstract #3972 Kumar et al
’
1:1 1:1
Median Follow Up: 36 Months
100 100 80 80 60 60 40 40 20 20 0 0 0 6 12 18 24 30 0 6 12 18 24 30 36 36 Rd RD
1.00 1.00 Probability of OS Probability of OS 0.8 0.75 0.6 0.50 P = .0017 0.4 0.25 CR + VGPR (n = 445) 0.2 CR or better PR PD PR (n = 288) VGPR SD 0 0 1 2 3 4 5 6 7 1 2 3 4 5 6 7 8 1
HD melphalan IgA remained normal Kappa light chain rose Renal failure on Dialysis Short lived response to High Dose Melphalan
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100 1.0 0.9 Patients without progression (%) 80 0.8 Time to progression (%) 0.7 60 0.6 0.5 40 0.4 0.3 20 0.2 0.1 P-value : p<0.0001 0 0.0 20 40 50 0 10 30 0 12 24 36 48 6 18 30 42
MRD at post-maintenance for arm A MRD at post-maintenance for arm B 1.0 1.0 Negative (<10-6) Negative (<10-6) 0.9 0.9 Patients without progression (%) 0.8 0.8 0.7 0.7 Positive Positive 0.6 0.6 0.5 0.5 0.4 0.4 P-value : p<0.0001 P-value : p=0.0007 0.3 0.3 0.2 0.2 0.1 0.1 0.0 0.0 0 12 24 36 48 0 12 24 36 48 6 18 30 42 6 18 30 42 Months since randomization Months since randomization N at risk N at risk (events) (events) -6 ) MRD neg (<10 50 (0) 50 (0) 50 (0) 50 (0) 50 (2) 47 (2) 37 (3) 22 (0) 4 -6 ) MRD neg (<10 36 (0) 36 (0) 36 (0) 36 (0) 36 (3) 30 (1) 24 (2) 14 (0) 6 MRD positive 45 (0) 45 (0) 45 (0) 45 (2) 42 (10) 31 (5) 21 (6) 7 (0) 2 MRD positive 47 (0) 47 (0) 47 (0) 47 (5) 41 (7) 33 (6) 24 (7) 4 (1) 3
PR VGPR CR sCR 35 ORR = 31% 3% 30 2% CR or 1% better 13% 25 VGPR or 10% better ORR, % 20 15 10 18% 5 0 16 mg/kg N = 148
Responders MR/SD PD/NE
CD16 Elotuzumab
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• T Cell Anti-BCMA • T Cell T Cell Anti-BCMA Anti-BCMA T Cell Anti-BCMA • •
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