DARATUMUMAB, a CD38 Monoclonal Antibody Study in Advanced Multiple Myeloma - an Open-Label, Dose Escalation Followed by Open-Label Extension in a Single-Arm Phase I/II Study

STOCKHOLM, June 14, 2013 /PRNewswire/ --

Dr Henk Lokhorst will present the results from a phase I/II study in advanced Multiple Myeloma.

Multiple myeloma is the second most common hematological cancer. It is a cancer of the plasma cells and it accounts for approx. 1% of all cancers. At present, no cure is available. The 5-year relative survival rate for multiple myeloma is around 40% so there is a strong need for new treatment modalities to improve the survival.

Daratumumab is a human CD38 monoclonal antibody being tested against multiple myeloma, but it could also have potential in a broad range of other hematological diseases.

Daratumumab has received Fast Track Designation and Breakthrough Therapy Designation from the US FDA for the treatment of multiple myeloma patients who have relapsed after other therapies and have no further treatment options. Breakthrough Therapy Designation is a program intended to expedite the development and review of drugs to treat serious or life-threatening diseases.

Daratumumab is currently in development as single agent and in combination with other compounds. Here at EHA, we present updated results from the ongoing GEN501 study aiming to recruit 78 heavily pretreated patients. The primary objective of this study is to establish the safety profile of daratumumab whereas main secondary objectives are to evaluate the efficacy of daratumumab and establish the maximum tolerated dose (MTD).

Daratumumab has to date been well tolerated with most common adverse events reported being infusion related reactions. At doses up to and including 2mg/kg it has shown promising efficacy with 31% of patients achieving a response and 67% of patients in dose cohorts 4 mg/kg and above achieving a response. This is currently unprecedented for single-agent treatment of Multiple Myeloma.

Presenter : Henk Lokhorst

Affiliation : University Medical Center Utrecht, Netherlands

Topic: DARATUMUMAB, A CD38 MONOCLONAL ANTIBODY STUDY IN ADVANCED MULTIPLE MYELOMA - AN OPEN-LABEL, DOSE ESCALATION FOLLOWED BY OPEN-LABEL EXTENSION IN A SINGLE-ARM PHASE I/II STUDY (abstract S576)