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This is an excerpt from a story in HemOnc Today. Read the full article here. 

Richard Furman, M.D. Patients with Waldenström macroglobulinemia had a favorable overall response and tolerance to ofatumumab monotherapy, according to an open-label, single-arm, phase 2 study published in The Lancet Hematology.

“Findings in this study might have major clinical significance for patients with Waldenström macroglobulinemia and warrant further assessment,” Richard R. Furman, M.D., distinguished associate professor of medicine at Weill Cornell Medicine, and colleagues wrote.

“Immunotherapy offers the potential of clinical efficacy without the marrow toxicity of cytotoxic chemotherapy. The large proportion of patients with a response and the low risk [for] initial immunoglobulin M (IgM) flare suggests that ofatumumab might be a nonchemotherapeutic treatment option for patients with Waldenström macroglobulinemia, particularly those with high IgM concentration.”

Before the FDA approved ibrutinib (Imbruvica; Janssen, Pharmacyclics) in January 2015 for patients with Waldenström macroglobulinemia, there were no treatments specifically approved for the disease. Ibrutinib, however, can have adverse events, such as diarrhea, bleeding risk, hypertension, joint pain and atrial fibrillation.

Furman and colleagues designed their study to assess the safety and clinical activity of IV ofatumumab monotherapy for untreated and relapsed Waldenström macroglobulinemia .

The researchers identified 37 adult patients — from six hospitals and cancer centers in the United States — who were untreated or had relapsed.

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Furman and colleagues acknowledged they were unable to draw any conclusions regarding the efficacy of ofatumumab compared with rituximab (Rituxan; Genentech, Biogen), because they did not obtain information on the outcome and tolerability of previous rituximab treatments, and because of the difficulties comparing across two separate phase 2 studies. They noted their findings are further limited by the small sample size and the change in dosing regimen for all patients, which prevented a definitive conclusion.

“These findings indicate that response to ofatumumab in Waldenström macroglobulinemia is a prolonged process, supporting the hypothesis that the therapy kills a compartment of malignant lymphocytes that probably differentiate into the IgM–secreting cells, which die at a standard rate,” Furman and colleagues wrote.

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