Safety
death, DLTs, overdose, toxicity, immune‐related TEAEs, thrombocytopenia, TEAEs, PTCL, DLBCL, anemia, lymphopenia, cHL, deaths, peripheral T‐cell lymphoma
DISEASE, THROMBOCYTOPENIA, ANEMIA, LYMPHOPENIA, ADVERSE EVENT, CHL, INFUSION REACTION, LYMPHOMA, INTESTINAL PERFORATION, URINARY TRACT INFECTION, HODGKIN'S LYMPHOMA
TEAEs were reported in 83.3% of the patients in the cHL anti‐PD‐1/PD‐L1 naïve cohort and in all patients in the remaining cohorts (Table Safety summary by cohort, all‐treated population
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.No Grade 5 (fatal) TEAEs were reported in the cHL cohorts. There were 4 deaths reported during the on‐treatment period in the DLBCL cohort (2 progressive disease, 1 intestinal perforation, 1 urinary tract infection) and 2 deaths in the PTCL cohort (1 unknown cause, 1 progressive disease); however, no deaths were treatment‐related (Table TEAEs reported in ≥20% of patients are shown in Table TEAEs in ≥20% of patients by cohort
Abbreviations: cHL, classic Hodgkin's lymphoma; DLBCL, diffuse large B‐cell lymphoma; PD‐1, programmed death‐1; PD‐L1, programmed death ligand‐1; PTCL, peripheral T‐cell lymphoma; TEAE, treatment‐emergent adverse event.The most commonly reported all‐grade hematological laboratory abnormality was anemia (88.9% [cHL anti‐PD‐1/PD‐L1 naïve], 58.3% [cHL anti‐PD‐1/PD‐L1 progressors], 100% [DLBCL and PTCL]). The most frequent Grade ≥3 hematological laboratory abnormalities were lymphopenia in all cohorts (27.8% [cHL anti‐PD‐1/PD‐L1 naïve], 8.3% [cHL anti‐PD‐1/PD‐L1 progressors], 43.8% [DLBCL], and 36.4% [PTCL]), and thrombocytopenia (36.4%) in the PTCL cohort (Table 