Study design and participants
tumor, death, immune‐related disease/conditions, HL, toxicity, Cemi, PTCL, DLBCL, cHL, anti‐PD‐L2, peripheral T‐cell lymphoma
TUMOR, LYMPHOMA, DISEASE, CHL, ONCOLOGY, CLASSIC HODGKIN LYMPHOMA
This was a Phase 1/2 multicenter, non‐comparative, open‐label study. Patients were enrolled at 23 study sites in seven countries (France, Italy, Republic of Korea, Netherlands, Portugal, Spain, and Taiwan).Eligible patients were ≥12 years old and had disease location amenable to tumor biopsy at baseline, measurable disease, and histologically confirmed advanced cHL, DLBCL, or PTCL that had relapsed or progressed after previous therapy. The number of previous therapies required for inclusion differed by cohort: ≥3 (cHL anti‐PD‐1/PD‐L1 naïve), 1 anti–PD‐1/PD‐L1–containing regimen (cHL anti‐PD‐1/PD‐L1 progressors), 2 (DLBCL), and 1 (PTCL). Key exclusion criteria were prior exposure to anti‐CD38, anti–PD‐1/PD‐L1 (except for cHL anti–PD‐1/PD‐L1 progressors), anti‐PD‐L2, anti‐CD137, anti‐CTLA4, or anti‐LAG3 agents, evidence of other immune‐related disease/conditions, Eastern Cooperative Oncology Group (ECOG) performance status ≥2, poor bone marrow reserve, and poor organ function. Among cHL anti‐PD‐1/PD‐L1 progressors, 3 patients were refractory to a prior anti‐PD‐1 agent. One patient who had a partial response (PR) with prior pembrolizumab developed progressive disease upon rechallenge.The study was in two parts (study design in Figure Study design. Cemi, cemiplimab; cHL, classic Hodgkin lymphoma (HL); DLBCL, diffuse large B‐cell lymphoma; DLT, dose‐limiting toxicity; Isa, isatuximab; PD‐1, programmed death‐1; PD‐L1, programmed death ligand‐1; PTCL, peripheral T‐cell lymphoma