Safety data in patients with R/R PTCL and CTCL
| TRAEs in ≥5% of patients,∗ n (%) . | PTCL (n = 33) . | CTCL (n = 29) . | ||
|---|---|---|---|---|
| Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | |
| All TRAEs | 28 (84.8) | 15 (45.5) | 26 (89.7) | 13 (44.8) |
| Fatigue | 8 (24.2) | 2 (6.1) | 4 (13.8) | 0 |
| Nausea | 6 (18.2) | 0 | 6 (20.7) | 0 |
| Pyrexia | 6 (18.2) | 0 | 5 (17.2) | 0 |
| Neutropenia | 5 (15.2) | 5 (15.2) | 0 | 0 |
| Peripheral neuropathy | 5 (15.2) | 1 (3.0) | 8 (27.6) | 0 |
| Diarrhea | 5 (15.2) | 1 (3.0) | 6 (20.7) | 1 (3.4) |
| Anemia | 5 (15.2) | 1 (3.0) | 1 (3.4) | 0 |
| Increased aspartate aminotransferase | 5 (15.2) | 0 | 3 (10.3) | 1 (3.4) |
| Paresthesia | 5 (15.2) | 0 | 1 (3.4) | 0 |
| Thrombocytopenia | 4 (12.1) | 2 (6.1) | 1 (3.4) | 1 (3.4) |
| Peripheral sensory neuropathy | 4 (12.1) | 1 (3.0) | 2 (6.9) | 0 |
| Infusion-related reaction | 4 (12.1) | 0 | 6 (20.7) | 1 (3.4) |
| Pruritis | 4 (12.1) | 0 | 2 (6.9) | 0 |
| Arthralgia | 4 (12.1) | 0 | 1 (3.4) | 0 |
| Rash | 3 (9.1) | 0 | 4 (13.8) | 2 (6.9) |
| Increased alanine aminotransferase | 2 (6.1) | 0 | 2 (6.9) | 0 |
| Pneumonitis† | 2 (6.1) | 0 | 1 (3.4)‡ | 1 (3.4)‡ |
| Increased blood alkaline phosphatase | 2 (6.1) | 0 | 0 | 0 |
| Rash maculo-papular | 1 (3.0) | 0 | 2 (6.9) | 1 (3.4) |
| Dermatitis exfoliative generalized | 0 | 0 | 4 (13.8) | 2 (6.9) |
| Rash macular | 0 | 0 | 2 (6.9) | 0 |
| TRAEs in ≥5% of patients,∗ n (%) . | PTCL (n = 33) . | CTCL (n = 29) . | ||
|---|---|---|---|---|
| Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | |
| All TRAEs | 28 (84.8) | 15 (45.5) | 26 (89.7) | 13 (44.8) |
| Fatigue | 8 (24.2) | 2 (6.1) | 4 (13.8) | 0 |
| Nausea | 6 (18.2) | 0 | 6 (20.7) | 0 |
| Pyrexia | 6 (18.2) | 0 | 5 (17.2) | 0 |
| Neutropenia | 5 (15.2) | 5 (15.2) | 0 | 0 |
| Peripheral neuropathy | 5 (15.2) | 1 (3.0) | 8 (27.6) | 0 |
| Diarrhea | 5 (15.2) | 1 (3.0) | 6 (20.7) | 1 (3.4) |
| Anemia | 5 (15.2) | 1 (3.0) | 1 (3.4) | 0 |
| Increased aspartate aminotransferase | 5 (15.2) | 0 | 3 (10.3) | 1 (3.4) |
| Paresthesia | 5 (15.2) | 0 | 1 (3.4) | 0 |
| Thrombocytopenia | 4 (12.1) | 2 (6.1) | 1 (3.4) | 1 (3.4) |
| Peripheral sensory neuropathy | 4 (12.1) | 1 (3.0) | 2 (6.9) | 0 |
| Infusion-related reaction | 4 (12.1) | 0 | 6 (20.7) | 1 (3.4) |
| Pruritis | 4 (12.1) | 0 | 2 (6.9) | 0 |
| Arthralgia | 4 (12.1) | 0 | 1 (3.4) | 0 |
| Rash | 3 (9.1) | 0 | 4 (13.8) | 2 (6.9) |
| Increased alanine aminotransferase | 2 (6.1) | 0 | 2 (6.9) | 0 |
| Pneumonitis† | 2 (6.1) | 0 | 1 (3.4)‡ | 1 (3.4)‡ |
| Increased blood alkaline phosphatase | 2 (6.1) | 0 | 0 | 0 |
| Rash maculo-papular | 1 (3.0) | 0 | 2 (6.9) | 1 (3.4) |
| Dermatitis exfoliative generalized | 0 | 0 | 4 (13.8) | 2 (6.9) |
| Rash macular | 0 | 0 | 2 (6.9) | 0 |
| . | PTCL (n = 33) . | CTCL (n = 29) . |
|---|---|---|
| Deaths, n (%) | 26 (78.8) | 14 (48.3) |
| Disease | 21 (63.6) | 11 (37.9) |
| Graft-versus-host disease§ | 1 (3.0) | 0 |
| Pneumonia | 1 (3.0) | 0 |
| Pneumonitis | 1 (3.0) | 0 |
| Respiratory | 1 (3.0) | 0 |
| Infection due to leg amputation | 0 | 1 (3.4) |
| MRSA and GBS bacteremia | 0 | 1 (3.4) |
| Septic shock | 0 | 1 (3.4) |
| Unknown | 1 (3.0)‖ | 0 |
| . | PTCL (n = 33) . | CTCL (n = 29) . |
|---|---|---|
| Deaths, n (%) | 26 (78.8) | 14 (48.3) |
| Disease | 21 (63.6) | 11 (37.9) |
| Graft-versus-host disease§ | 1 (3.0) | 0 |
| Pneumonia | 1 (3.0) | 0 |
| Pneumonitis | 1 (3.0) | 0 |
| Respiratory | 1 (3.0) | 0 |
| Infection due to leg amputation | 0 | 1 (3.4) |
| MRSA and GBS bacteremia | 0 | 1 (3.4) |
| Septic shock | 0 | 1 (3.4) |
| Unknown | 1 (3.0)‖ | 0 |
GBS, group B Streptococcus; MRSA, methicillin-resistant Staphylococcus aureus.
Up to 30 days following last dose.
One instance of pneumonitis in the PTCL cohort was grade 5.
Incidence was classed as hypersensitivity pneumonitis.
Death from graft-versus-host disease occurred 245 days posttransplant after last nivolumab dose.
Patient achieved a best overall response of CR on the study but stopped study treatment and subsequently received an allogeneic transplant. No details on the cause of death are known but the patient did not have PD.