Table 2 Response rates by adjudicated mIWG–MRT–ECNM response criteria
Best confirmed response, n (%) | All AdvSM (n = 32) | AdvSM subtype | Previous therapy | Previous midostaurin | ||||
|---|---|---|---|---|---|---|---|---|
ASM (n = 2) | SM-AHN (n = 26) | MCL (n = 4) | Yes (n = 23) | No (n = 9) | Yes (n = 17) | No (n = 15) | ||
ORR (CR + CRh + PR + Cl) | 24 (75) | 2 (100) | 21 (81) | 1 (25) | 17 (74) | 7 (78) | 14 (82) | 10 (67) |
95% Confidence interval | 57–89 | 16–100 | 61–93 | 1–81 | 52–90 | 40–97 | 57–96 | 38–88 |
Best response | ||||||||
CR or CRh | 6 (19) | 1 (50) | 5 (19) | 0 | 3 (13) | 3 (33) | 3 (18) | 3 (20) |
CR | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
CRh | 6 (19) | 1 (50) | 5 (19) | 0 | 3 (13) | 3 (33) | 3 (18) | 3 (20) |
PR | 10 (31) | 1 (50) | 8 (31) | 1 (25) | 7 (30) | 3 (33) | 5 (29) | 5 (33) |
CI | 8 (25) | 0 | 8 (31) | 0 | 7 (30) | 1 (11) | 6 (35) | 2 (13) |
Stable disease | 4 (13) | 0 | 2 (8) | 2 (50) | 2 (9) | 2 (22) | 0 | 4 (27) |
Progressive disease | 1 (3) | 0 | 0 | 1 (25) | 1 (4) | 0 | 0 | 1 (7) |
Not evaluable | 3 (9)a | 0 | 3 (12) | 0 | 3 (13) | 0 | 3 (18) | 0 |