Page 324 - Haematologica Vol. 109 - July 2024
P. 324
LETTER TO THE EDITOR
to avoid step-up dosing and in-patient hospitalization can benefit significantly from the more manageable dosing regimen of belantamab mafodotin, at a minimum of every 3 to 6 weeks or longer.
In addition, in cases of aggressive relapses where treat- ment should be initiated promptly, belantamab mafodotin in combination with other therapies can provide a rapid and successful alternative, bypassing the long delays as-
sociated with prolonged manufacturing process required for CAR T-cell therapies, as one example.
Considering the safety profile, belantamab mafodotin has been shown to be manageable in most patients in both the investigational9,10 and real-world14,15 settings. Eye-relat- ed side effects are proving better tolerated and reversible with a low rate of treatment discontinuation due to ocular adverse events now being reported (for example, 2% of the
Table 1. Baseline characteristics and outcomes of the patients treated with belantamab mafodotin in DREAMM-2 trial and in the published real-world experience.
DREAMM-2 trial
Spain
Israel
France IFM 2020-04
Mayo clinic
Italy
Athens
N=97
N=156
N=106
N=97
N=36
N=28
N=27
Basal characteris tics of patients receiving belantamab mafodotin
Age in years, median (range)
65 (60-70)
73 (40-89)
69 (36-88)
66 (37-82)
61 (37-83)
68 (51-83)
65 (41-81)
Sex: male, N (%)
51 (53)
82 (46)
60 (57)
49 (51)
23 (64)
16 (57)
14 (52)
Prior lines of tx., median (range)
7 (3-21)
5 (1-10)
6 (2-11)
5 (3-12)
8 (7-11)
6 (3-14)
5 (4-10)
ISS, %
II III
22 34 43
29 31 33
43 30 26
36 39 25
25 17 33
NR NR NR
33 48 19
High-risk cytogenetics, N (%)
41 (42)
del17p, 17 t(4;14), 15 1q21+, 28 t(14;20), 1
27 (43)
27/66 (41)
14 (41)
NR
6/15 (40)
Triple-class refractory, N (%)
97 (100)
125 (80)
77 (73)
55 (56)
36 (100)
28 (100)
27 (100)
Prior tx., N (%) ASCT
Carfilzomib Poma
73 (75) 74 (76) 89 (92)
101 (65) NR NR
62 (59) 77 (73) 82 (77)
70 (72) 11 (11) 60 (62)
27 (75) 36 (100) 36 (100)
20 (71) 24 (86) NR
25 (93) 24 (89) 19 (70)
Median PFS in months
2.8
11
14.5
9.5
6.5
8
16
Efficacy outcomes
Landmark mOS in months
13.7
11
14.5
9.5
6.5
8
16
ORR, N (%)
31 (32)
14 (42)
46 (46)
37 (38)
12 (33)
11 (40)
14 (52)
sCR/CR, N (%)
7 (7)
4 (12)
4 (4)
8 (8)
2 (6)
3 (11)
3 (11)
VGPR, N (%)
11 (11)
2 (6)
14 (14)
11 (11)
3 (8)
3 (11)
5 (19)
PR, N (%)
13 (13)
8 (24)
28 (28)
18 (19)
7 (19)
5 (18)
6 (22)
Safety outcomes
Keratopathy, N (%)
68 (72)
73 (88)
65 (68)
39 (38)
15 (43)
9 (32)
9 (33)
Infusion-related reaction, N (%).
20 (21)
NR
8 (8)
10 (10)
2 (5)
0
1 (4)
Adapted from Ntanasis-Stathopoulus_Int. J. Mol. Sci. 202315. ASCT: autologous stem cell transplant; ISS: international staging system; m: me- dian; NR: not reported; OS: overall survival; ORR: overall response rate; PFS: progression-free survival; poma: pomalidomide; PR: partial re- sponse; tx: treatment; (s)CR: (stringent) complete response; VGPR: very good partial response.
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