Janssen terminates daratumab development in NHL

Genmab A/S said today that its partner, Janssen Biotech, Inc., has decided not to initiate stage 2 of the Phase II study (CARINA, LYM2001) of daratumumab in three types of relapsed or refractory non-Hodgkin’s lymphoma (NHL).  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.

Other ongoing or planned studies with daratumumab are not affected by the decision. “Daratumumab is still being investigated in a number of indications including multiple myeloma and other hematological cancers such as NK/T-cell lymphoma and myelodysplastic syndrome as well as in solid tumours,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The CARINA LYM2001 study (NCT02413489) was a three arm (DLBCL, FL, MCL), open-label multicenter study, designed to enrol up to 210 patients in two stages with relapsed or refractory non-Hodgkin’s lymphoma. Stage 1 of the study was designed to provide a preliminary assessment of monotherapy activity, with stage 2 designed to further evaluate safety and efficacy of daratumumab monotherapy. The primary endpoint of the study was overall response rate. The safety profile of daratumumab in these diseases was also assessed.