Summary of IRRs with modakafusp alfa
IRR or time relative to infusion . | Modakafusp alfa . | Total (N = 146) . | |
---|---|---|---|
120 mg q4w (n = 71) . | 240 mg q4w (n = 75) . | ||
Any IRR, n (%) | 18 (25.4) | 12 (16.0) | 30 (20.5) |
Signs and symptoms (all grades), n (%) | 18 (25.4) | 12 (16.0) | 30 (20.5) |
Chills | 5 (7.0) | 4 (5.3) | 9 (6.2) |
Flushing | 5 (7.0) | 2 (2.7) | 7 (4.8) |
Back pain | 3 (4.2) | 3 (4.0) | 6 (4.1) |
Nausea | 3 (4.2) | 3 (4.0) | 6 (4.1) |
Pruritus | 2 (2.8) | 4 (5.3) | 6 (4.1) |
Hypotension | 3 (4.2) | 2 (2.7) | 5 (3.4) |
Pyrexia | 2 (2.8) | 3 (4.0) | 5 (3.4) |
Chest discomfort | 1 (1.4) | 2 (2.7) | 3 (2.1) |
Headache | 1 (1.4) | 2 (2.7) | 3 (2.1) |
No. of IRR events | 37 | 18 | 55 |
Time relative to infusion, n (%) | |||
Start of infusion to before the EOI | 27 (73.0) | 10 (55.6) | 37 (67.3) |
At or after EOI to <2 hours after infusion | 7 (18.9) | 4 (22.2) | 11 (20.0) |
≥2 hours after infusion to <4 hours after infusion | 2 (5.4) | 0 | 2 (3.6) |
≥4 hours post-infusion to <6 hours post-infusion | 0 | 1 (5.6) | 1 (1.8) |
≥6 hours after infusion | 1 (2.7) | 1 (5.6) | 2 (3.6) |
Unknown IRR time | 0 | 2 (11.1) | 2 (3.6) |
IRR or time relative to infusion . | Modakafusp alfa . | Total (N = 146) . | |
---|---|---|---|
120 mg q4w (n = 71) . | 240 mg q4w (n = 75) . | ||
Any IRR, n (%) | 18 (25.4) | 12 (16.0) | 30 (20.5) |
Signs and symptoms (all grades), n (%) | 18 (25.4) | 12 (16.0) | 30 (20.5) |
Chills | 5 (7.0) | 4 (5.3) | 9 (6.2) |
Flushing | 5 (7.0) | 2 (2.7) | 7 (4.8) |
Back pain | 3 (4.2) | 3 (4.0) | 6 (4.1) |
Nausea | 3 (4.2) | 3 (4.0) | 6 (4.1) |
Pruritus | 2 (2.8) | 4 (5.3) | 6 (4.1) |
Hypotension | 3 (4.2) | 2 (2.7) | 5 (3.4) |
Pyrexia | 2 (2.8) | 3 (4.0) | 5 (3.4) |
Chest discomfort | 1 (1.4) | 2 (2.7) | 3 (2.1) |
Headache | 1 (1.4) | 2 (2.7) | 3 (2.1) |
No. of IRR events | 37 | 18 | 55 |
Time relative to infusion, n (%) | |||
Start of infusion to before the EOI | 27 (73.0) | 10 (55.6) | 37 (67.3) |
At or after EOI to <2 hours after infusion | 7 (18.9) | 4 (22.2) | 11 (20.0) |
≥2 hours after infusion to <4 hours after infusion | 2 (5.4) | 0 | 2 (3.6) |
≥4 hours post-infusion to <6 hours post-infusion | 0 | 1 (5.6) | 1 (1.8) |
≥6 hours after infusion | 1 (2.7) | 1 (5.6) | 2 (3.6) |
Unknown IRR time | 0 | 2 (11.1) | 2 (3.6) |