Table 3.
Treatment-emergent adverse events at grade ≥3 and IRR incidence according to grade
| TEAEs,an (%) | DLBCL | FL | Other iNHL | MCL | Total |
|---|---|---|---|---|---|
| N = 35 | N = 34 | N = 11 | N = 12 | N = 92 | |
| Any grade ≥3b | 19 (54) | 9 (27) | 5 (46) | 4 (33) | 37 (40) |
| Hematologicalc | |||||
| Neutropenia | 6 (17) | 2 (6) | 0 | 0 | 8 (9) |
| Thrombocytopenia | 2 (6) | 1 (3) | 0 | 1 (8) | 4 (4) |
| Anemia | 3 (9) | 0 | 0 | 0 | 3 (3) |
| Non-hematologicalc | |||||
| Dyspnea | 2 (6) | 1 (3) | 0 | 1 (8) | 4 (4) |
| Pneumoniad | 3 (9) | 0 | 0 | 0 | 3 (3) |
| Fatigue | 1 (3) | 1 (3) | 0 | 0 | 2 (2) |
| Hypokalemia | 1 (3) | 1 (3) | 0 | 0 | 2 (2) |
| Infusion-related reaction,an (%) | |||||
| Any | 4 (11) | 4 (12) | 1 (9) | 2 (17) | 11e (12) |
| Grade 1/2 | 4 (11) | 3 (9) | 1 (9) | 2 (17) | 10 (11) |
| Grade 4 | 0 | 1 (3) | 0 | 0 | 1 (1) |
Data are number of patients (%).
TEAEs according to the Medical Dictionary for Regulatory Activities preferred term (PT).
TEAEs including PT disease progression.
TEAEs reported at grade ≥3 in two or more patients overall.
In two patients, pneumonia started during the extended treatment phase (days 706 and 468, respectively), both patients recovered within 2 weeks. One patient developed pneumonia with cardiorespiratory failure (unrelated to MOR208 treatment) in cycle 1 (day 23) with a fatal outcome.
No grade 3 or grade 5 infusion-related reactions were reported.
DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; iNHL, indolent non-Hodgkin’s lymphoma; MCL, mantle cell lymphoma; TEAEs, treatment emergent adverse events.