Summary of efficacy end points
| . | Mezagitamab cohort . | ||||||
|---|---|---|---|---|---|---|---|
| 45 mg (n = 4) . | 135 mg (n = 3) . | 300 mg (n = 12) . | 600 mg (n = 22) . | 1200 mg (n = 3) . | PomDex (n = 6) . | Total (N = 50) . | |
| Best overall response∗ (confirmed/unconfirmed) | n = 4 | n = 3 | n = 12 | n = 19 | n = 3 | n = 6 | N = 47 |
| ORR, n (%) [95% CI] | 1 (25) [0.6-80.6] | 0 | 5 (42) [15.2-72.3] | 9 (47) [24.4-71.1] | 1 (33) [0.8-90.6] | 5 (83) [35.9-99.6] | 21 (45) [30.2-59.9] |
| ≥VGPR, n (%) [95% CI] | 0 | 0 | 1 (8) [0.2-38.5] | 2 (11) [1.3-33.1] | 1 (33) [0.8-90.6] | 0 | 4 (9) [2.4-20.4] |
| sCR or CR, n (%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| VGPR, n (%) | 0 | 0 | 1 (8) | 2 (11) | 1 (33) | 0 | 4 (9) |
| PR, n (%) | 1 (25) | 0 | 4 (33) | 7 (37) | 0 | 5 (83) | 17 (36) |
| MR, n (%) | 0 | 1 (33) | 0 | 2 (11) | 0 | 1 (17) | 4 (9) |
| SD, n (%) | 2 (50) | 2 (67) | 5 (42) | 5 (26) | 2 (67) | 0 | 16 (34) |
| PD, n (%) | 1 (25) | 0 | 2 (17) | 3 (16) | 0 | 0 | 6 (13) |
| Responder outcomes (patients with a PR or better) (confirmed† ) | n = 1; PR | n = 0 | n = 5; 1 VGPR, 4 PR | n = 4; PR | n = 1; VGPR | n = 4; PR | N = 15; 2 VGPR, 13 PR |
| Median time to response, mo (range) | 2.1 (2.1-2.1) | – | 1.3 (1.0-3.7) | 1.1 (1.0-1.9) | 1.0 (1.0-1.0) | 2.5 (1.0-4.4) | 1.3 (1.0-4.4) |
| Median DOR, mo (range) | 3.0 (3.0-3.0) | – | 3.7 (1.8-28.0) | 22.1 (10.1-30.2) | NE (27.6∗-27.6∗) | 6.7 (1.2∗-22.7∗) | 11.3 (1.2∗-30.2) |
| PFS | |||||||
| Patients with an event, n (%) | 4 (100) | 2 (67) | 12 (100) | 19 (86) | 2 (67) | 4 (67) | 43 (86) |
| Median, mo (range) | 2.9 (0.7-31.6) | 2.9 (0.3-36.4‡) | 3.5 (2.1-28.6‡) | 8.8 (3.3-23.8‡) | 3.7 (0.3-36.4‡) | ||
| OS | |||||||
| Patients with event, n (%) | 1 (25) | 0 | 7 (58) | 6 (27) | 1 (33) | 1 (17) | 16 (32) |
| Median, mo (range) | 30.4 (10.3-38.4‡) | NE (0.8-36.4‡) | NE (4.9-28.6‡) | NE (3.3-28.1‡) | NE (0.8-44.0‡) | ||
| . | Mezagitamab cohort . | ||||||
|---|---|---|---|---|---|---|---|
| 45 mg (n = 4) . | 135 mg (n = 3) . | 300 mg (n = 12) . | 600 mg (n = 22) . | 1200 mg (n = 3) . | PomDex (n = 6) . | Total (N = 50) . | |
| Best overall response∗ (confirmed/unconfirmed) | n = 4 | n = 3 | n = 12 | n = 19 | n = 3 | n = 6 | N = 47 |
| ORR, n (%) [95% CI] | 1 (25) [0.6-80.6] | 0 | 5 (42) [15.2-72.3] | 9 (47) [24.4-71.1] | 1 (33) [0.8-90.6] | 5 (83) [35.9-99.6] | 21 (45) [30.2-59.9] |
| ≥VGPR, n (%) [95% CI] | 0 | 0 | 1 (8) [0.2-38.5] | 2 (11) [1.3-33.1] | 1 (33) [0.8-90.6] | 0 | 4 (9) [2.4-20.4] |
| sCR or CR, n (%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| VGPR, n (%) | 0 | 0 | 1 (8) | 2 (11) | 1 (33) | 0 | 4 (9) |
| PR, n (%) | 1 (25) | 0 | 4 (33) | 7 (37) | 0 | 5 (83) | 17 (36) |
| MR, n (%) | 0 | 1 (33) | 0 | 2 (11) | 0 | 1 (17) | 4 (9) |
| SD, n (%) | 2 (50) | 2 (67) | 5 (42) | 5 (26) | 2 (67) | 0 | 16 (34) |
| PD, n (%) | 1 (25) | 0 | 2 (17) | 3 (16) | 0 | 0 | 6 (13) |
| Responder outcomes (patients with a PR or better) (confirmed† ) | n = 1; PR | n = 0 | n = 5; 1 VGPR, 4 PR | n = 4; PR | n = 1; VGPR | n = 4; PR | N = 15; 2 VGPR, 13 PR |
| Median time to response, mo (range) | 2.1 (2.1-2.1) | – | 1.3 (1.0-3.7) | 1.1 (1.0-1.9) | 1.0 (1.0-1.0) | 2.5 (1.0-4.4) | 1.3 (1.0-4.4) |
| Median DOR, mo (range) | 3.0 (3.0-3.0) | – | 3.7 (1.8-28.0) | 22.1 (10.1-30.2) | NE (27.6∗-27.6∗) | 6.7 (1.2∗-22.7∗) | 11.3 (1.2∗-30.2) |
| PFS | |||||||
| Patients with an event, n (%) | 4 (100) | 2 (67) | 12 (100) | 19 (86) | 2 (67) | 4 (67) | 43 (86) |
| Median, mo (range) | 2.9 (0.7-31.6) | 2.9 (0.3-36.4‡) | 3.5 (2.1-28.6‡) | 8.8 (3.3-23.8‡) | 3.7 (0.3-36.4‡) | ||
| OS | |||||||
| Patients with event, n (%) | 1 (25) | 0 | 7 (58) | 6 (27) | 1 (33) | 1 (17) | 16 (32) |
| Median, mo (range) | 30.4 (10.3-38.4‡) | NE (0.8-36.4‡) | NE (4.9-28.6‡) | NE (3.3-28.1‡) | NE (0.8-44.0‡) | ||
PomDex was given in combination with mezagitamab 300 mg (administered per the product label).
CI, confidence interval; CR, complete response; MR, minimal response; NE, not estimable; OS, overall survival; sCR, stringent complete response; SD, stable disease; VGPR, very good partial response.
Best overall responses did not require 2 consecutive assessments and included a combination of confirmed and unconfirmed responses.
All objective responses required at least 2 consecutive assessments made at any time before the institution of a new therapy to be considered confirmed.
Censored observations.