Phase II study of daratumumab will not proceed

Genmab has announced that its collaboration partner for daratumumab, Janssen Biotech, has decided to not initiate stage 2 of the Phase II study of daratumumab in three types of relapsed or refractory non-Hodgkin’s lymphoma (NHL).

The decision to not proceed with the second stage of the study was taken as a data review showed that two cohorts of the study — investigating the use of daratumumab monotherapy in relapsed or refractory patients with follicular lymphoma (FL) and with diffuse large B-cell lymphoma (DLBCL) — did not reach the predefined futility thresholds of overall response rates (ORR) of 50% and 30%, respectively. In the third cohort, patients with mantle cell lymphoma (MCL), ORR could not be evaluated as a result of slow recruitment, driven by the aggressive nature of the disease in its final stages.

“While we hoped that daratumumab as a monotherapy could potentially provide a new treatment option in NHL patients with a high unmet medical need, the preliminary activity profile seen was not sufficient for the study to continue,” said Jan van de Winkel, PhD, chief executive officer of Genmab. “Daratumumab is still being investigated in a number of indications including multiple myeloma and other haematological cancers, such as NK/T-cell lymphoma and myelodysplastic syndrome as well as in solid tumours.”