Exploratory Analysis of Factors Influencing Efficacy and Safety of Camidanlumab Tesirine: Data from the Open-Label, Multicenter, Phase 2 Study of Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (R/R cHL)

(eng) INTRODUCTION: Despite most patients with cHL being cured with standard therapies, a proportion of patients are refractory or relapse after first- and second-line treatments (1L/2L), including stem cell transplantation, and there are limited treatment options available after failure of brentuximab vedotin (BV) and PD-1 blockade. Camidanlumab tesirine (Cami) is an antibody-drug conjugate comprising an anti-CD25 monoclonal antibody conjugated through a cleavable linker to a pyrrolobenzodiazepine (PBD) dimer. Cami has shown notable single-agent anti-tumor activity and manageable toxicity in the Phase 2 trial of patients with R/R cHL (Carlo-Stella et al, Hemasphere 2022;6:102-103). OBJECTIVES: To assess the clinical response and safety of Cami by subgroups based on demographics, known risk factors impacting outcomes in patients with R/R cHL, and factors with potential relevance to Cami's mechanism of action. METHODS: This analysis was based on the open-label, multicenter, Phase 2 study of Cami monotherapy in patients with R/R cHL after ≥3 prior lines of therapy (NCT04052997). Cami was administered (30-minute infusion) on day 1 of each 3-week cycle at 45 µg/kg for 2 cycles, then 30 µg/kg for subsequent cycles. Subgroup analyses (data cutoff: March 16, 2022) were conducted (Table 1). Efficacy outcomes included the overall response rate (ORR) and median duration of response (mDOR); statistical significance was assessed by comparison of 95% confidence intervals. Safety was assessed by incidence of treatment emergent adverse events (TEAEs). [...]