Key clinical point:
Major finding: The overall response rate was 12.5% for patients with follicular lymphoma and 6.7% for diffuse large B-cell lymphoma (DLBCL). There were no responders in the mantle cell lymphoma cohort.
Study details: An open-label, phase 2 trial involving 15 patients with diffuse large B-cell lymphoma, 16 patients with follicular lymphoma, and 5 patients with mantle cell lymphoma.
Disclosures: The study was funded by Janssen Research & Development; two study authors reported employment by Janssen. Others reported financial ties to Janssen, Celgene, Roche, Gilead, Novartis, Amgen, and others.
Salles G et al. Clin Lymphoma Myeloma Leuk. 2019 Jan 2. doi: 10.1016/j.clml.2018.12.013.
Dr. David Henry, Editor in Chief of MDedge Hematology/Oncology, comments:
Daratumumab has enjoyed great success in frontline or relapsed myeloma studies, but not so here in this equally difficult patient population with relapsed/refractory non-Hodgkin lymphoma. The study population was enriched with CD38 positivity ( more than 50% of patients) because of preclinical models suggesting that daratumumab was more effective when CD38 was highly expressed.
Of 36 patients on the trial, 15 had diffuse large B-cell lymphoma, 16 had follicular lymphoma, and 5 had mantle cell lymphoma with a median CD38 expression of 70%. Daratumumab was given at 16 mg/kg IV once a week for two cycles, then every 2 weeks for four cycles, and finally on a monthly basis. Infusion-related reactions occurred in 72.2% of patients and other adverse events included thrombocytopenia, which was grade 3 in 11% of patients.
Very disappointingly, the overall response rate was 12.5% in follicular lymphoma, occurring in only two patients; 6.7% in diffuse large B-cell lymphoma, with response from just one patient; and no response in patients with mantle cell lymphoma. Accordingly, the authors have chosen not to take this regimen/study forward in a larger cohort of relapsed/refractory NHL.