Baseline patient demographics and characteristics
| . | Modakafusp alfa . | Total (N = 146) . | |
|---|---|---|---|
| 120 mg q4w (n = 71) . | 240 mg q4w (n = 75) . | ||
| Age, median (range), y | 67 (36-82) | 68 (42-90) | 67.0 (36-90) |
| Male, n (%) | 37 (52.1) | 36 (48.0) | 73 (50.0) |
| Race, n (%) | |||
| White | 38 (53.5) | 51 (68.0) | 89 (61.0) |
| Black or African American | 10 (14.1) | 4 (5.3) | 14 (9.6) |
| Asian | 5 (7.0) | 9 (12.0) | 14 (9.6) |
| Not reported | 18 (25.4) | 11 (14.7) | 29 (19.9) |
| Weight at baseline, median (range), kg | 76.9 (40.0-116.0) | 75.0 (39.0-135.3) | 76.0 (39.0-135.3) |
| ECOG PS, n (%) | |||
| 0 | 18 (25.4) | 23 (30.7) | 41 (28.1) |
| 1 | 45 (63.4) | 43 (57.3) | 88 (60.3) |
| 2 | 8 (11.3) | 9 (12.0) | 17 (11.6) |
| ISS at screening, n (%) | |||
| I | 33 (46.5) | 35 (46.7) | 68 (46.6) |
| II | 19 (26.8) | 21 (28.0) | 40 (27.4) |
| III | 19 (26.8) | 19 (25.3) | 38 (26.0) |
| Median time from initial diagnosis (range), y | 7.2 (2.1-20.2) | 6.8 (1.1-19.4) | 6.9 (1.1-20.2) |
| Extramedullary disease at diagnosis, n (%) | 13 (18.3) | 17 (22.7) | 30 (20.5) |
| Extramedullary disease at study entry, n (%) | 14 (20.0) | 20 (26.7) | 34 (23.4) |
| Heavy chain type, n (%) | |||
| IgG | 39 (54.9) | 41 (54.7) | 80 (54.8) |
| IgA | 14 (19.7) | 18 (24.0) | 32 (21.9) |
| Other∗ | 17 (23.9) | 16 (21.3) | 31 (21.2) |
| Light chain type, n (%) | |||
| Kappa | 40 (56.3) | 45 (60.0) | 85 (58.2) |
| Lambda | 30 (42.3) | 29 (38.7) | 59 (40.4) |
| Other† | 1 (1.4) | 1 (1.3) | 2 (1.4) |
| Cytogenetic risk, n (%) | |||
| High risk | 22 (33.3) | 17 (27.4) | 39 (30.5) |
| Standard risk | 26 (39.4) | 21 (33.9) | 47 (36.7) |
| No. of previous LoTs, median (range) | 6 (3-17) | 6 (3-15) | 6 (3-17) |
| Type of previous therapy, n (%) | |||
| Anti-CD38 mAb | 71 (100) | 75 (100) | 146 (100) |
| Anti-CD38 mAb in last LoT | 13 (18.3) | 15 (20.0) | 28 (19.2) |
| PI | 71 (100) | 75 (100) | 146 (100) |
| IMiD | 71 (100) | 75 (100) | 146 (100) |
| Autologous stem cell transplant | 57 (80.3) | 51 (68.0) | 108 (74.0) |
| Anti-BCMA | 34 (47.9) | 32 (42.7) | 66 (45.2) |
| Antibody-drug conjugate | 13 (18.3) | 19 (25.3) | 32 (21.9) |
| CAR T-cell therapy | 12 (16.9) | 9 (12.0) | 21 (14.4) |
| T-cell engager | 20 (28.2) | 13 (17.3) | 33 (22.6) |
| Penta-exposed‡ | 48 (67.6) | 49 (65.3) | 97 (66.4) |
| Refractory status, n (%) | |||
| Anti-CD38 mAb | 71 (100) | 75 (100) | 146 (100) |
| PI | 71 (100) | 75 (100) | 146 (100) |
| IMiD | 70 (98.6) | 75 (100) | 145 (99.3) |
| Anti-BCMA | 25 (35.2) | 29 (38.7) | 54 (37.0) |
| Antibody-drug conjugate | 10 (14.1) | 19 (25.3) | 29 (19.9) |
| CAR T-cell therapy | 4 (5.6) | 6 (8.0) | 10 (6.8) |
| T-cell engager | 20 (28.2) | 15 (20.0) | 35 (24.0) |
| Triple-refractory§ and penta-exposed‡ | 47 (66.2) | 49 (65.3) | 96 (65.8) |
| Penta-refractory|| | 30 (42.3) | 20 (26.7) | 50 (34.2) |
| . | Modakafusp alfa . | Total (N = 146) . | |
|---|---|---|---|
| 120 mg q4w (n = 71) . | 240 mg q4w (n = 75) . | ||
| Age, median (range), y | 67 (36-82) | 68 (42-90) | 67.0 (36-90) |
| Male, n (%) | 37 (52.1) | 36 (48.0) | 73 (50.0) |
| Race, n (%) | |||
| White | 38 (53.5) | 51 (68.0) | 89 (61.0) |
| Black or African American | 10 (14.1) | 4 (5.3) | 14 (9.6) |
| Asian | 5 (7.0) | 9 (12.0) | 14 (9.6) |
| Not reported | 18 (25.4) | 11 (14.7) | 29 (19.9) |
| Weight at baseline, median (range), kg | 76.9 (40.0-116.0) | 75.0 (39.0-135.3) | 76.0 (39.0-135.3) |
| ECOG PS, n (%) | |||
| 0 | 18 (25.4) | 23 (30.7) | 41 (28.1) |
| 1 | 45 (63.4) | 43 (57.3) | 88 (60.3) |
| 2 | 8 (11.3) | 9 (12.0) | 17 (11.6) |
| ISS at screening, n (%) | |||
| I | 33 (46.5) | 35 (46.7) | 68 (46.6) |
| II | 19 (26.8) | 21 (28.0) | 40 (27.4) |
| III | 19 (26.8) | 19 (25.3) | 38 (26.0) |
| Median time from initial diagnosis (range), y | 7.2 (2.1-20.2) | 6.8 (1.1-19.4) | 6.9 (1.1-20.2) |
| Extramedullary disease at diagnosis, n (%) | 13 (18.3) | 17 (22.7) | 30 (20.5) |
| Extramedullary disease at study entry, n (%) | 14 (20.0) | 20 (26.7) | 34 (23.4) |
| Heavy chain type, n (%) | |||
| IgG | 39 (54.9) | 41 (54.7) | 80 (54.8) |
| IgA | 14 (19.7) | 18 (24.0) | 32 (21.9) |
| Other∗ | 17 (23.9) | 16 (21.3) | 31 (21.2) |
| Light chain type, n (%) | |||
| Kappa | 40 (56.3) | 45 (60.0) | 85 (58.2) |
| Lambda | 30 (42.3) | 29 (38.7) | 59 (40.4) |
| Other† | 1 (1.4) | 1 (1.3) | 2 (1.4) |
| Cytogenetic risk, n (%) | |||
| High risk | 22 (33.3) | 17 (27.4) | 39 (30.5) |
| Standard risk | 26 (39.4) | 21 (33.9) | 47 (36.7) |
| No. of previous LoTs, median (range) | 6 (3-17) | 6 (3-15) | 6 (3-17) |
| Type of previous therapy, n (%) | |||
| Anti-CD38 mAb | 71 (100) | 75 (100) | 146 (100) |
| Anti-CD38 mAb in last LoT | 13 (18.3) | 15 (20.0) | 28 (19.2) |
| PI | 71 (100) | 75 (100) | 146 (100) |
| IMiD | 71 (100) | 75 (100) | 146 (100) |
| Autologous stem cell transplant | 57 (80.3) | 51 (68.0) | 108 (74.0) |
| Anti-BCMA | 34 (47.9) | 32 (42.7) | 66 (45.2) |
| Antibody-drug conjugate | 13 (18.3) | 19 (25.3) | 32 (21.9) |
| CAR T-cell therapy | 12 (16.9) | 9 (12.0) | 21 (14.4) |
| T-cell engager | 20 (28.2) | 13 (17.3) | 33 (22.6) |
| Penta-exposed‡ | 48 (67.6) | 49 (65.3) | 97 (66.4) |
| Refractory status, n (%) | |||
| Anti-CD38 mAb | 71 (100) | 75 (100) | 146 (100) |
| PI | 71 (100) | 75 (100) | 146 (100) |
| IMiD | 70 (98.6) | 75 (100) | 145 (99.3) |
| Anti-BCMA | 25 (35.2) | 29 (38.7) | 54 (37.0) |
| Antibody-drug conjugate | 10 (14.1) | 19 (25.3) | 29 (19.9) |
| CAR T-cell therapy | 4 (5.6) | 6 (8.0) | 10 (6.8) |
| T-cell engager | 20 (28.2) | 15 (20.0) | 35 (24.0) |
| Triple-refractory§ and penta-exposed‡ | 47 (66.2) | 49 (65.3) | 96 (65.8) |
| Penta-refractory|| | 30 (42.3) | 20 (26.7) | 50 (34.2) |
CAR, chimeric antigen receptor; ECOG PS, Eastern Cooperative Oncology Group performance status; ISS, International Staging System; q4w, every 4 weeks.
Includes IgD, IgE, biclonal, and none.
Includes biclonal, unknown, and missing data.
Exposed to 2 PIs, 2 IMiDs, and an anti-CD38 mAb.
Refractory to an IMiD, a PI, and an anti-CD38 mAb.
Refractory to 2 PIs, 2 IMiDs, and an anti-CD38 mAb.