High response incidence seen for axatilimab in recurrent, refractory graft-versus-host disease

For patients with recurrent or refractory graft-versus-host disease (GVHD), the colony-stimulating factor 1 receptor (CSF1R)-blocking antibody axatilimab results in a high incidence of overall response, according to a study published in the New England Journal of Medicine.

Daniel Wolff, M.D., from University Hospital Regensburg in Germany, and colleagues examined three different doses of axatilimab in a phase 2 study involving patients with recurrent or refractory chronic GVHD.

Patients were randomly assigned to receive axatilimab, administered intravenously, at a dose of 0.3 mg, 1 mg, or 3 mg per kilogram of body weight every two weeks, every two weeks, and every four weeks, respectively (80, 81, and 80 patients in the 0.3-mg, 1-mg, and 3-mg dose groups, respectively). The primary end point was overall response in the first six cycles (complete or partial response).

The researchers found that the primary end point was met in all dose groups; an overall response was seen in 74, 67, and 50% of patients in the 0.3-mg, 1-mg, and 3-mg dose groups, respectively. In the three dose groups, there was a reduction of more than 5 points on the modified Lee Symptom Scale in 60, 69, and 41% of patients, respectively. Dose-dependent transient laboratory abnormalities related to CSF1R blockade were the most common adverse events.

“The study met its primary end point and showed the efficacy of axatilimab in patients across all three dose groups, with an overall response occurring in 50 to 74% of the patients,” the authors write.

The study was funded by Incyte and Syndax Pharmaceuticals, which manufacture and license axatilimab.

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