Characteristics of patients at baseline, overall, and in the 1.5 and 3 mg/kg Q4W cohorts
| Characteristic . | All patients (N = 106) . | 1.5 mg/kg Q4W cohorts∗ (n = 30) . | 3 mg/kg Q4W cohort (n = 7) . |
|---|---|---|---|
| Median age (range), y | 64.5 (34-84) | 66.5 (40-84) | 68 (43-78) |
| Male sex, n (%) | 62 (58.5) | 14 (46.7) | 5 (71.4) |
| Race, n (%) | |||
| White | 82 (77.4) | 25 (83.3) | 5 (71.4) |
| Black or African American | 17 (16.) | 2 (6.7) | 1 (14.3) |
| Asian | 4 (3.8) | 2 (6.7) | 0 |
| Not reported | 3 (2.8) | 1 (3.3) | 1 (14.3) |
| Median time since diagnosis (range), y | 5.6 (1.4-22.7) | 6.4 (1.8-16.2) | 8.7 (1.8-13.5) |
| Extramedullary disease at diagnosis, n (%) | 23 (21.7) | 4 (13.3) | 2 (28.6) |
| ECOG performance status score† , n (%) | |||
| 0 | 16 (15.1) | 4 (13.3) | 2 (28.6) |
| ≥1 | 84 (79,2) | 26 (86.7) | 5 (71.4) |
| Missing | 2 (1.9) | 0 | 0 |
| International Staging System class, n (%) | |||
| I | 40 (37.7) | 15 (50) | 4 (57.1) |
| II | 43 (40.6) | 11 (36.7) | 2 (28.6) |
| III | 14 (13.2) | 2 (6.7) | 1 (14.3) |
| Missing | 9 (13.2) | 2 (6.7) | 0 |
| High-risk cytogenetics profile‡, n/N (%) | 26/81 (32.1) | 8/25 (32) | 0 |
| Median no. of lines of previous therapy (range) | 6.5 (3-19) | 6.5 (3-16) | 6 (3-10) |
| Previous stem cell transplantation, n (%) | 86 (81.1) | 23 (76.7) | 5 (71.4) |
| Previous therapy exposure, n (%) | |||
| Anti-CD38 monoclonal antibody§ | 96 (90.6) | 29 (96.7) | 6 (85.7) |
| Anti-BCMA agent | 44 (41.5) | 15 (50) | 3 (42.9) |
| Chimeric antigen receptor T cell therapy‖ | 19 (17.9) | 8 (26.7) | 1 (14.3) |
| Bispecific T cell engager¶ | 15 (14.2) | 6 (20) | 1 (14.3) |
| Refractory status# , n (%) | |||
| Anti-CD38 monoclonal antibody§ | 89 (84) | 28 (93.3) | 4 (57.1) |
| Triple class∗∗ | 88 (83) | 28 (93.3) | 4 (57.1) |
| Penta drug†† | 48 (45.3) | 14 (46.7) | 1 (14.3) |
| Anti-BCMA agent | 37 (34.9) | 12 (40) | 2 (28.6) |
| Last line of therapy | 85 (80.2) | 25 (83.3) | 3 (42.9) |
| Characteristic . | All patients (N = 106) . | 1.5 mg/kg Q4W cohorts∗ (n = 30) . | 3 mg/kg Q4W cohort (n = 7) . |
|---|---|---|---|
| Median age (range), y | 64.5 (34-84) | 66.5 (40-84) | 68 (43-78) |
| Male sex, n (%) | 62 (58.5) | 14 (46.7) | 5 (71.4) |
| Race, n (%) | |||
| White | 82 (77.4) | 25 (83.3) | 5 (71.4) |
| Black or African American | 17 (16.) | 2 (6.7) | 1 (14.3) |
| Asian | 4 (3.8) | 2 (6.7) | 0 |
| Not reported | 3 (2.8) | 1 (3.3) | 1 (14.3) |
| Median time since diagnosis (range), y | 5.6 (1.4-22.7) | 6.4 (1.8-16.2) | 8.7 (1.8-13.5) |
| Extramedullary disease at diagnosis, n (%) | 23 (21.7) | 4 (13.3) | 2 (28.6) |
| ECOG performance status score† , n (%) | |||
| 0 | 16 (15.1) | 4 (13.3) | 2 (28.6) |
| ≥1 | 84 (79,2) | 26 (86.7) | 5 (71.4) |
| Missing | 2 (1.9) | 0 | 0 |
| International Staging System class, n (%) | |||
| I | 40 (37.7) | 15 (50) | 4 (57.1) |
| II | 43 (40.6) | 11 (36.7) | 2 (28.6) |
| III | 14 (13.2) | 2 (6.7) | 1 (14.3) |
| Missing | 9 (13.2) | 2 (6.7) | 0 |
| High-risk cytogenetics profile‡, n/N (%) | 26/81 (32.1) | 8/25 (32) | 0 |
| Median no. of lines of previous therapy (range) | 6.5 (3-19) | 6.5 (3-16) | 6 (3-10) |
| Previous stem cell transplantation, n (%) | 86 (81.1) | 23 (76.7) | 5 (71.4) |
| Previous therapy exposure, n (%) | |||
| Anti-CD38 monoclonal antibody§ | 96 (90.6) | 29 (96.7) | 6 (85.7) |
| Anti-BCMA agent | 44 (41.5) | 15 (50) | 3 (42.9) |
| Chimeric antigen receptor T cell therapy‖ | 19 (17.9) | 8 (26.7) | 1 (14.3) |
| Bispecific T cell engager¶ | 15 (14.2) | 6 (20) | 1 (14.3) |
| Refractory status# , n (%) | |||
| Anti-CD38 monoclonal antibody§ | 89 (84) | 28 (93.3) | 4 (57.1) |
| Triple class∗∗ | 88 (83) | 28 (93.3) | 4 (57.1) |
| Penta drug†† | 48 (45.3) | 14 (46.7) | 1 (14.3) |
| Anti-BCMA agent | 37 (34.9) | 12 (40) | 2 (28.6) |
| Last line of therapy | 85 (80.2) | 25 (83.3) | 3 (42.9) |
Representativeness of study patients are shown in supplemental Table 3.
ECOG, Eastern Cooperative Oncology Group.
Includes patients in dose escalation (n = 5) and dose expansion (n = 25).
Scores on the ECOG performance status scale range from 0 to 5, with higher scores indicating greater disability.
del 17, t(4;14), or t(14;16).
Anti-CD38 monoclonal antibodies included daratumumab and isatuximab.
BCMA-targeted in 18 patients overall, 8 patients in the 1.5 mg/kg cohort, and 1 patient in the 3 mg/kg cohort.
BCMA-targeted in 9 patients overall, 2 patients the 1.5 mg/kg cohort, and 1 patient in the 3 mg/kg cohort.
Refractory status defined as disease progression while on treatment or <60 days from last exposure to the drug.
Refractory to an IMiD, a PI, and an anti-CD38 antibody.
Refractory to bortezomib, carfilzomib, lenalidomide, pomalidomide and an anti-CD38 antibody.