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Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia

Robert Kreitman 1 Claire Dearden 2 Pier Luigi Zinzani 3 Julio Delgado 4 Lionel Karlin 5 Tadeusz Robak 6 Douglas Gladstone 7 Philipp Le Coutre 8 Sascha Dietrich 9 Mirjana Gotic 10 Loree Larratt 11 Fritz Offner 12 Gary Schiller 13 Ronan Swords 14 Larry Bacon 15 Monica Bocchia 16 Krimo Bouabdallah 17 Dimitri Breems 18 Agostino Cortelezzi 19 Shira Dinner 20 Michael Doubek 21 Bjørn Tore Gjertsen 22 Marco Gobbi 23 Andrzej Hellmann 24 Stéphane Leprêtre 25, 26 Frédéric Maloisel 27 Farhad Ravandi 28 Philipp Rousselot 29 Mathias Rummel 30 Tanya Siddiqi 31 Tamar Tadmor 32 Xavier Troussard 33 Cecilia Arana Yi 34 Giuseppe Saglio 35 Gail Roboz 36 Kemal Balic 37 Nathan Standifer 37 Peng He 37 Shannon Marshall 37 Wyndham Wilson 38 Ira Pastan 38 Nai-Shun Yao 37 Francis Giles 20
Abstract : This is a pivotal, multicenter, open-label study of moxetumomab pasudotox, a recombinant CD22-targeting immunotoxin, in hairy cell leukemia (HCL), a rare B cell malignancy with high CD22 expression. The study enrolled patients with relapsed/ refractory HCL who had ≥2 prior systemic therapies, including ≥1 purine nucleoside analog. Patients received moxetumomab pasudotox 40 µg/kg intravenously on days 1, 3, and 5 every 28 days for ≤6 cycles. Blinded independent central review determined disease response and minimal residual disease (MRD) status. Among 80 patients (79% males; median age, 60.0 years), durable complete response (CR) rate was 30%, CR rate was 41%, and objective response rate (CR and partial response) was 75%; 64 patients (80%) achieved hematologic remission. Among complete responders, 27 (85%) achieved MRD negativity by immunohistochemistry. The most frequent adverse events (AEs) were peripheral edema (39%), nausea (35%), fatigue (34%), and headache (33%). Treatment-related serious AEs of hemolytic uremic syndrome (7.5%) and capillary leak syndrome (5%) were reversible and generally manageable with supportive care and treatment discontinuation (6 patients; 7.5%). Moxetumomab pasudotox treatment achieved a high rate of independently assessed durable response and MRD eradication in heavily pretreated patients with HCL, with acceptable tolerability.
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Robert Kreitman, Claire Dearden, Pier Luigi Zinzani, Julio Delgado, Lionel Karlin, et al.. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia. Leukemia, Nature Publishing Group: Open Access Hybrid Model Option B, 2018, 32 (8), pp.1768-1777. ⟨10.1038/s41375-018-0210-1⟩. ⟨hal-02194148⟩

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