Response to mogamulizumab and follow-up data in the 44 study patients
| . | All patients (N = 44) . | SS patients with RAM* (n = 14) . | Patients without RAM (n = 30) . | P (RAM vs no RAM) . | MF patients (n = 9) . | SS patients (n = 35) . | SS patients without RAM (n = 21) . | P (SS – RAM vs no RAM) . |
|---|---|---|---|---|---|---|---|---|
| BOR in skin | ||||||||
| Progression | 8 (18) | 2 (14) | 6 (20) | .41 | 2 (22) | 6 (17) | 4 (19 | 1 |
| Stable disease | 10 (23) | 3 (21) | 7 (23) | 3 (33) | 7 (20) | 4 (19) | ||
| PR | 22 (50) | 9 (64) | 13 (43) | 3 (33) | 19 (54) | 10 (53) | ||
| CR | 4 (9) | 0 (0) | 4 (13) | 1 (11) | 3 (9) | 3 (14) | ||
| PR + CR | 26 (59) | 9 (64) | 17 (57) | 4 (44) | 22 (63) | 13 (62) | ||
| BOR in blood in SS patients | ||||||||
| Progression | 1 (3) | 0 (0) | 1 (3) | .65 | NA | 1 (3) | 1 (3) | .50 |
| Stable disease | 1 (3) | 0 (0) | 1 (3) | 1 (3) | 1 (3) | |||
| PR | 15 (40) | 7 (50) | 8 (27) | 15 (40) | 8 (27) | |||
| CR | 18 (54) | 7 (50) | 11 (37) | 18 (54) | 11 (37) | |||
| PR + CR | 33 (94) | 14 (100) | 19 (63) | 33 (94) | 19 (63) | |||
| BOR overall (skin and blood) | ||||||||
| Progression | 9 (20) | 2 (14) | 7 (23) | .33 | 2 (22) | 7 (20) | 5 (24) | .74 |
| Stable disease | 10 (23) | 3 (21) | 7 (23) | 3 (33) | 7 (20) | 4 (19) | ||
| PR | 21 (48) | 9 (64) | 12 (40) | 3 (33) | 18 (54) | 9 (43) | ||
| CR | 4 (9) | 0 (0) | 4 (13) | 1 (11) | 3 (9) | 3 (14) | ||
| PR + CR | 25 (57) | 9 (64) | 16 (53) | 4 (44) | 21 (60) | 12 (57) | ||
| Time to BOR | 333 [15-2121] | 453 [21-1893] | 273 [15-2121] | .19 | 120 [35-284] | 382 [15-2121] | 332 [15-2121] | .34 |
| Follow-up duration, d | 681 [23-2223] | 887 [118-2223] | 605 [23-2096] | .93 | 413 [24-978] | 768 [23-2223] | 688 [23-2096] | .98 |
| Duration of mogamulizumab, d | 449 [7-2357] | 490 [57-2047] | 430 [7-2357] | .39 | 170 [7-631] | 521 [14-2357] | 542 [14-2357] | 1 |
| Still under mogamulizumab at last follow-up | 3 (7) | 1 (7) | 2 (7) | 1 | 0 (0) | 3 (9) | 2 (10) | 1 |
| Time to next treatment, d | 434 [23-2567] | 1650 [127-2482] | 215 [23-2567] | .01 | 158 [24-942] | 652 [23-2567] | 365 [23-2567] | .06 |
| Time to progression, d | 353 [7-2567] | 1650 [120-2482] | 181 [7-2567] | .01 | 113 [7-942] | 444 [18-2567] | 341 [18-2567] | .04 |
| . | All patients (N = 44) . | SS patients with RAM* (n = 14) . | Patients without RAM (n = 30) . | P (RAM vs no RAM) . | MF patients (n = 9) . | SS patients (n = 35) . | SS patients without RAM (n = 21) . | P (SS – RAM vs no RAM) . |
|---|---|---|---|---|---|---|---|---|
| BOR in skin | ||||||||
| Progression | 8 (18) | 2 (14) | 6 (20) | .41 | 2 (22) | 6 (17) | 4 (19 | 1 |
| Stable disease | 10 (23) | 3 (21) | 7 (23) | 3 (33) | 7 (20) | 4 (19) | ||
| PR | 22 (50) | 9 (64) | 13 (43) | 3 (33) | 19 (54) | 10 (53) | ||
| CR | 4 (9) | 0 (0) | 4 (13) | 1 (11) | 3 (9) | 3 (14) | ||
| PR + CR | 26 (59) | 9 (64) | 17 (57) | 4 (44) | 22 (63) | 13 (62) | ||
| BOR in blood in SS patients | ||||||||
| Progression | 1 (3) | 0 (0) | 1 (3) | .65 | NA | 1 (3) | 1 (3) | .50 |
| Stable disease | 1 (3) | 0 (0) | 1 (3) | 1 (3) | 1 (3) | |||
| PR | 15 (40) | 7 (50) | 8 (27) | 15 (40) | 8 (27) | |||
| CR | 18 (54) | 7 (50) | 11 (37) | 18 (54) | 11 (37) | |||
| PR + CR | 33 (94) | 14 (100) | 19 (63) | 33 (94) | 19 (63) | |||
| BOR overall (skin and blood) | ||||||||
| Progression | 9 (20) | 2 (14) | 7 (23) | .33 | 2 (22) | 7 (20) | 5 (24) | .74 |
| Stable disease | 10 (23) | 3 (21) | 7 (23) | 3 (33) | 7 (20) | 4 (19) | ||
| PR | 21 (48) | 9 (64) | 12 (40) | 3 (33) | 18 (54) | 9 (43) | ||
| CR | 4 (9) | 0 (0) | 4 (13) | 1 (11) | 3 (9) | 3 (14) | ||
| PR + CR | 25 (57) | 9 (64) | 16 (53) | 4 (44) | 21 (60) | 12 (57) | ||
| Time to BOR | 333 [15-2121] | 453 [21-1893] | 273 [15-2121] | .19 | 120 [35-284] | 382 [15-2121] | 332 [15-2121] | .34 |
| Follow-up duration, d | 681 [23-2223] | 887 [118-2223] | 605 [23-2096] | .93 | 413 [24-978] | 768 [23-2223] | 688 [23-2096] | .98 |
| Duration of mogamulizumab, d | 449 [7-2357] | 490 [57-2047] | 430 [7-2357] | .39 | 170 [7-631] | 521 [14-2357] | 542 [14-2357] | 1 |
| Still under mogamulizumab at last follow-up | 3 (7) | 1 (7) | 2 (7) | 1 | 0 (0) | 3 (9) | 2 (10) | 1 |
| Time to next treatment, d | 434 [23-2567] | 1650 [127-2482] | 215 [23-2567] | .01 | 158 [24-942] | 652 [23-2567] | 365 [23-2567] | .06 |
| Time to progression, d | 353 [7-2567] | 1650 [120-2482] | 181 [7-2567] | .01 | 113 [7-942] | 444 [18-2567] | 341 [18-2567] | .04 |
Data are presented as No. (%) among patients or as mean (range).
BOR, best overall response; CR, complete response; HDAC, histone deacetylase; HSCT, hematopoietic stem cell transplantation; PR, partial response.
All patients with RAM were SS patients.