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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 lymphoma
Author(s) -
Fanale Michelle,
Assouline Sarit,
Kuruvilla John,
SolalCéligny Philippe,
Heo Dae S.,
Verhoef Gregor,
Corradini Paolo,
Abramson Jeremy S.,
Offner Fritz,
Engert Andreas,
Dyer Martin J. S.,
Carreon Daniel,
Ewald Brett,
Baeck Johan,
Younes Anas,
Freedman Arnold S.
Publication year - 2014
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.12630
Subject(s) - lymphoma , medicine , follicular lymphoma , monoclonal antibody , radioimmunotherapy , refractory (planetary science) , gastroenterology , malt lymphoma , antibody , immunology , biology , astrobiology
Summary 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 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 CD 40 warrants further investigation.