Response to modakafusp alfa by investigator assessment
. | Modakafusp alfa . | Total (N = 146) . | |
---|---|---|---|
120 mg q4w (n = 71) . | 240 mg q4w (n = 75) . | ||
ORR,∗ n (%) | 23 (32.4) | 31 (41.3) | 54 (37.0) |
95% CI | 21.8-44.6 | 30.1-53.3 | 29.2-45.4 |
Clinical benefit rate,† n (%) | 27 (38.0) | 36 (48.0) | 63 (43.2) |
95% CI | 26.8-50.3 | 36.3-59.9 | 35.0-51.6 |
Disease control rate,‡ n (%) | 53 (74.6) | 51 (68.0) | 104 (71.2) |
95% CI | 62.9-84.2 | 56.2-78.3 | 63.2-78.4 |
Best confirmed overall response,§ n (%) | |||
Stringent CR | 1 (1.4) | 1 (1.3) | 2 (1.4) |
CR | 0 (0) | 1 (1.3) | 1 (0.7) |
VGPR | 13 (18.3) | 12 (16.0) | 25 (17.1) |
PR | 9 (12.7) | 17 (22.7) | 26 (17.8) |
MR | 4 (5.6) | 5 (6.7) | 9 (6.2) |
SD | 26 (36.6) | 15 (20.0) | 41 (28.1) |
PD | 12 (16.9) | 15 (20.0) | 27 (18.5) |
Not evaluable | 3 (4.2) | 2 (2.7) | 5 (3.4) |
. | Modakafusp alfa . | Total (N = 146) . | |
---|---|---|---|
120 mg q4w (n = 71) . | 240 mg q4w (n = 75) . | ||
ORR,∗ n (%) | 23 (32.4) | 31 (41.3) | 54 (37.0) |
95% CI | 21.8-44.6 | 30.1-53.3 | 29.2-45.4 |
Clinical benefit rate,† n (%) | 27 (38.0) | 36 (48.0) | 63 (43.2) |
95% CI | 26.8-50.3 | 36.3-59.9 | 35.0-51.6 |
Disease control rate,‡ n (%) | 53 (74.6) | 51 (68.0) | 104 (71.2) |
95% CI | 62.9-84.2 | 56.2-78.3 | 63.2-78.4 |
Best confirmed overall response,§ n (%) | |||
Stringent CR | 1 (1.4) | 1 (1.3) | 2 (1.4) |
CR | 0 (0) | 1 (1.3) | 1 (0.7) |
VGPR | 13 (18.3) | 12 (16.0) | 25 (17.1) |
PR | 9 (12.7) | 17 (22.7) | 26 (17.8) |
MR | 4 (5.6) | 5 (6.7) | 9 (6.2) |
SD | 26 (36.6) | 15 (20.0) | 41 (28.1) |
PD | 12 (16.9) | 15 (20.0) | 27 (18.5) |
Not evaluable | 3 (4.2) | 2 (2.7) | 5 (3.4) |
IMWG, International Myeloma Working Group; MR, minimal response; PD, progressive disease; PR, partial response; sCR, stringent CR; SD, stable disease; VGPR, very good partial response.
Defined as the proportion of patients who achieved a confirmed PR or better during the study as defined by IMWG uniform response criteria.
Defined as the proportion of patients with a confirmed response of sCR, CR, VGPR, PR, or MR; ORR + MR.
Defined as the proportion of patients with a confirmed response of sCR, CR, VGPR, PR, MR, or SD.
Ten patients had no postbaseline response assessment.