TABLE 2.
Safety summary by cohort, all‐treated population
| Cohort A1: cHL (anti‐PD‐1/PD‐L1 naïve) (n = 18) | Cohort A2: cHL (anti‐PD‐1/PD‐L1 progressors) (n = 12) | Cohort B: DLBCL (n = 17) | Cohort C: PTCL (n = 11) | |
|---|---|---|---|---|
| Any TEAE | 15 (83.3) | 12 (100) | 17 (100) | 11 (100) |
| Grade ≥3 TEAE | 1 (5.6) | 1 (8.3) | 12 (70.6) | 9 (81.8) |
| Grade 5 TEAE (fatal outcome) | 0 | 0 | 4 (23.5) | 2 (18.2) |
| SAEs | 2 (11.1) | 2 (16.7) | 10 (58.8) | 7 (63.6) |
| Treatment‐related a TEAEs | 9 (50.0) | 11 (91.7) | 9 (52.9) | 8 (72.7) |
| Treatment‐related a Grade ≥3 TEAE | 0 | 0 | 1 (5.9) | 3 (27.3) |
| Treatment‐related SAE | 0 | 1 (8.3) | 2 (11.8) | 2 (18.2) |
| TEAE leading to treatment discontinuation | 0 | 0 | 1 (5.9) | 3 (27.3) |
| Any AESI b | 7 (38.9) | 8 (66.7) | 7 (41.2) | 7 (63.6) |
| Any IR | 7 (38.9) | 9 (75.0) | 8 (47.1) | 8 (72.7) |
Note: All data are shown as n (%).
Abbreviations: AE, adverse event; AESI, adverse event of special interest; cHL, classic Hodgkin's lymphoma; DLT, dose‐limiting toxicity; IR, infusion reaction; PD‐1, programmed death‐1; PD‐L1, programmed death ligand‐1; PI3K, phosphoinositide 3‐kinase; PTCL, peripheral T‐cell lymphoma; SAE, serious adverse event; TEAE, treatment‐emergent adverse event.
Treatment‐related TEAEs are TEAEs related to at least one drug of the combination.
AESIs include Grade ≥2 IRs, Grade ≥3 immune‐related TEAEs, immune‐related AEs of any grade in a patient previously treated with a PI3K inhibitor (only applicable for patients who received cemiplimab), DLTs as defined in Phase 1, pregnancy, symptomatic overdose with investigational medicinal product/non‐investigational medicinal product.