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)

Herrera, Alex F.;Ansell, Stephen M.;Zinzani, Pier Luigi;Radford, John;Carlo-Stella, Carmelo;et.al.
(2022) Blood — Vol. 140, n° Suppl 1, p. 3673-3677 (2022)

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Authors
  • Herrera, Alex F.
    Author
  • Ansell, Stephen M.
    Author
  • Zinzani, Pier Luigi
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  • Radford, John
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  • André, MarcUCLouvain
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  • Carlo-Stella, Carmelo
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Abstract
(en) 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). [...]
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Herrera, A. F., Ansell, S. M., Zinzani, P. L., Radford, J., Maddocks, K. J., Pinto, A., Collins, G. P., Bachanova, V., Bartlett, N. L., Bence-Bruckler, I., Hamadani, M., Kline, J., Mayer, J., Savage, K. J., Advani, R. H., Caimi, P. F., Casasnovas, R.-O., Feldman, T. A., Hess, B. T., et al. (2022). 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). Blood, 140(Suppl 1), 3673-3677. https://doi.org/10.1182/blood-2022-157583 (Original work published 2022)