Brentuximab vedotin phase 2 in relapsed systemic anaplastic large cell lymphoma (SG035-0004)

Systemic anaplastic large cell lymphoma uniformly expresses CD30. Brentuximab vedotin is an antibody against CD30 joined to monomethyl auristatin E, a drug that disrupts microtubules. This multicentre phase 2 study gave it at 1.8 mg/kg intravenously every three weeks, as an outpatient infusion, to 58 patients with systemic ALCL that had come back after at least one treatment; the primary endpoint was objective response by independent central review.

Fifty patients (86 per cent) responded and 33 (57 per cent) had a complete remission. The median durations of response and of complete remission were 12.6 and 13.2 months. Grade 3 or 4 adverse events in at least 10 per cent were neutropenia (21 per cent), thrombocytopenia (14 per cent) and peripheral sensory neuropathy (12 per cent). The five-year report (Blood 2017) found no progressions beyond 40 months and eight patients, 14 per cent of those enrolled, in sustained remission with neither a transplant nor any further treatment. The drug was approved in the United States in 2011 for relapsed systemic ALCL, and ECHELON-2 later moved it to first line.