Date: 2011-12-11
Type of information: Interim results
phase: 1-2
Announcement: interim results
Company: Genmab (Denmark)
Product: daratumumab (HuMax-CD38)
Action
mechanism: Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma. The CD38 molecule is highly expressed on the surface of multiple myeloma cells. CD38 is also expressed on a number of other hematological tumors, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma.
Disease: multiple myeloma
Therapeutic area: Cancer - Oncology
Country:
Trial
details: This ongoing Phase I/II dose escalation study will include a maximum of 122 patients with multiple myeloma that is relapsed or refractory to at least two different prior treatments. The primary objective of the study is to establish the safety profile of daratumumab and secondary objectives are to establish maximum tolerated dose and efficacy. An independent data monitoring committee evaluates the safety data for each cohort before dose-escalation.
Latest
news: Genmab has announced preliminary safety and efficacy data from the first Phase I/II clinical study of daratumumab (HuMax(r)-CD38) in multiple myeloma. A 49%, 55%, and 61% reduction in the serum M-component was observed in the three patients treated at the highest dose level examined so far (4 mg/kg of daratumumab). The serum M-component is an abnormal protein produced by the cancerous plasma cells and is a direct marker for tumor activity. Reduction in the serum M-component is a key factor for response evaluations in multiple myeloma. The observed level of reduction therefore indicates that daratumumab was clinically active in these multiple myeloma patients.
The data presented was from 23 patients who received daratumumab in doses up to 4mg/kg. The data also showed daratumumab has an acceptable safety profile. The most common adverse events seen in the study so far were pyrexia, cough, free hemoglobin, anemia, dizziness, hemolysis, flu-like illness, nausea, lymphopenia and monocytopenia.
