Date: 2015-12-09
Type of information: Initiation of preclinical development
phase: 2
Announcement:
Company: Janssen Research & Development, a J&J company (USA - NJ)
Product: daratumumab
Action
mechanism: monoclonal antibody. Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma. It targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells and may also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the FDA for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
Disease: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL)
Therapeutic area: Cancer - Oncology
Country: Australia, Belgium, France, Korea, Republic of, Netherlands, Turkey, USA
Trial
details: This open label, phase 2 study evaluates efficacy and safety of daratumumab in relapsed or refractory mantle Cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma. The purpose of this study is to assess overall response rate [ORR, including complete response (CR) and partial response (PR)] and to evaluate association between ORR and CD38 expression level in order to determine a threshold for CD38 expression level in each NHL subtype, above which daratumumab activity is enhanced in participants with relapsed or refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma. (NCT02413489 )
Latest
news: * On December 9, 2015, Genmab announced it has reached a $ 5 million milestone in its daratumumab collaboration with Janssen Biotech. The milestone payment was triggered by progress in the ongoing Phase II study ("Carina" LYM2001) of daratumumab in NHL. The study evaluates daratumumab monotherapy in three different types of NHL, diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and mantle cell lymphoma (MCL).
This Phase II study is a three arm (DLBCL, FL, MCL), open-label multicenter study which will enroll up to 210 patients with relapsed or refractory non-Hodgkin's lymphoma. Patients in the study will be treated with daratumumab monotherapy. The primary endpoint of the study is overall response rate. The safety profile of daratumumab in these diseases will also be assessed.
