Janssen Biotech, Inc will not proceed with Phase II trial of daratumumab for three types of relapsed or refractory non-Hodgkin's lymphoma (NHL).

Genmab A/S announced that its collaboration partner for daratumumab, Janssen Biotech, Inc., has decided not to initiate stage II of the Phase II study (CARINA, LYM2001) of daratumumab in three types of relapsed or refractory non-Hodgkin's lymphoma (NHL). The study will not proceed to stage 2 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 in the study, patients with mantle cell lymphoma (MCL), ORR was not evaluable due to slow recruitment, driven by the aggressive nature of the disease in its final stages. This has no impact on other ongoing or planned studies with daratumumab.