Table 3.
Summary of most common TEAEs in copanlisib clinical studies in patients with indolent and aggressive lymphoma
| Study | Phase I | Phase II | |||
|---|---|---|---|---|---|
| NCT00962611 [34]a | NCT01660451; part A [52] | CHRONOS-1, NCT01660451; part B [35] | CHRONOS-1, NCT01660451; part B long-term follow-up [36] | NCT02391116 [55] | |
| Number of patients | 9 | 84 | 142 | 142 | 67 |
| Patient lymphoma type | Indolent and aggressive | Indolent and aggressive | Indolent | Indolent | Aggressive |
| AEs leading to dose interruptions/modifications, n (%) | 14 (25.0) | 50 (59.5)/11 (13.1) | 105 (73.9)/37 (26.1)b; 8 (5.6)c | 116 (81.7)/40 (28.2) | 34 (50.7)/9 (13.4) |
| Grade 5 AEs, n (%) | 0 | 10 (11.9) | 6 (4.2) | 6 (4.2) | 14 (20.9) |
| AEs in ≥ 15% of patients (any grade), n (%) | |||||
| Hyperglycemia | 8 (88.9) | 50 (59.5) | 71 (50.0) | 71 (50.0) | 22 (32.8) |
| Nausea | 7 (77.8) | 28 (33.3) | 33 (23.2) | 33 (23.2) | 21 (31.3) |
| Hypertension | 3 (33.3) | 46 (54.8) | 43 (30.3) | 42 (29.6) | 27 (40.3) |
| Diarrhea | 3 (33.3) | 34 (40.5) | 48 (33.8) | 50 (35.2) | 25 (37.3) |
| Decreased neutrophil count/neutropenia | – | 29 (34.5) | 42 (29.6) | 41 (28.9) | 7 (10.4) |
| Fatigue | 3 (33.3) | 41 (48.8) | 43 (30.3) | 37 (26.1) | 19 (28.4) |
| Anemia | – | 24 (28.6) | 22 (15.5) | 25 (17.6) | – |
| Rash/desquamation | 2 (22.2) | – | 18 (12.7)d | – | 9 (13.4) |
| Oral mucositis | 3 (33.3) | 19 (22.6) | 28 (19.7) | – | – |
| Lung infection | – | 17 (20.2) | 30 (21.1) | – | – |
| Fever/pyrexia | – | 16 (19.0) | 36 (25.4) | 38 (26.8) | 14 (20.9) |
| Decreased platelet count/thrombocytopenia | – | 15 (17.9) | 29 (20.4) | 20 (14.1) | – |
| Headache | – | 15 (17.9) | – | – | 9 (13.4) |
| Urinary tract infection | – | 14 (16.7) | – | – | – |
| Dyspnea | – | 14 (16.7) | – | – | 7 (10.4) |
| Constipation | – | 13 (15.5) | 17 (12.0) | 18 (12.7) | 11 (16.4) |
| Cough | – | 10 (11.9) | 23 (16.2) | 27 (19.0) | 12 (17.9) |
Top five AEs with the highest incidence per study are in bold
AE adverse event, TEAE treatment-emergent adverse event
aDrug-related TEAEs are presented for this study
bDose reduction to 45 mg
cDose reduction to 30 mg
dMaculopapular