Phase IA/II, multicentre, open‐label study of the CD 40 antagonistic monoclonal antibody lucatumumab in adult patients with advanced non‐H odgkin or H odgkin …

M Fanale, S Assouline, J Kuruvilla… - British journal of …, 2014 - Wiley Online Library
M Fanale, S Assouline, J Kuruvilla, P Solal‐Céligny, DS Heo, G Verhoef, P Corradini…
British journal of haematology, 2014Wiley Online Library
Despite advancements in the treatment of non‐Hodgkin lymphoma (NHL) and H odgkin
lymphoma (HL), patients continue to relapse and thus a need for new targeted therapies
remains. The CD 40 receptor is highly expressed on neoplastic B cells and activation leads
to enhanced proliferation and survival. Lucatumumab (HCD 122) is a fully human
antagonistic CD 40 monoclonal antibody. A phase IA/II study was designed to determine the
maximum tolerated dose (MTD) and activity of lucatumumab in patients with …
Summary
Despite advancements in the treatment of non‐Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL), patients continue to relapse and thus a need for new targeted therapies remains. The CD40 receptor is highly expressed on neoplastic B cells and activation leads to enhanced proliferation and survival. Lucatumumab (HCD122) is a fully human antagonistic CD40 monoclonal antibody. A phase IA/II study was designed to determine the maximum tolerated dose (MTD) and activity of lucatumumab in patients with relapsed/refractory lymphoma. Determination of the MTD was the primary objective of the phase IA dose escalation portion and clinical response was the primary objective of the phase II dose expansion portion. Patients received escalating doses of lucatumumab administered intravenously once weekly for 4 weeks of an 8‐week cycle. MTD was determined at 4 mg/kg of lucatumumab. A total of 111 patients with NHL (n = 74) and HL (n = 37) were enrolled. Responses were observed across various lymphoma subtypes. The overall response rate by computed tomography among patients with follicular lymphoma (FL) and marginal zone lymphoma of mucosa‐associated lymphatic tissue (MZL/MALT) was 33·3% and 42·9%, respectively. Lucatumumab demonstrates modest activity in relapsed/refractory patients with advanced lymphoma, suggesting that targeting of CD40 warrants further investigation.
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