HGS' HGS-ETR1+Velcade enters Ph II MM trial

USA-based Human Genome Sciences has initiated dosing of patients in a randomized Phase II clinical trial of its anticancer drug candidate HGS-ETR1 (mapatumumab) in combination with Millennium Pharmaceuticals' Velcade (bortezomib) in advanced multiple myeloma.

The primary objective of the study is to evaluate disease response to the combination of drugs versus bortezomib alone, in patients with relapsed or refractory MM. The randomized, multicenter, open-label Phase II efficacy and safety study will enroll approximately 100 patients across the USA and Canada. Secondary objectives include the evaluation of safety and tolerability, and determination of HGS-ETR1 plasma concentrations for use in a population pharmacokinetic analysis.

HGS noted that the agent has completed three Phase II trials. In patients with non-Hodgkin's lymphoma, it was well tolerated and showed signs of clinical activity in relapsed or refractory subjects, and could be administered safely and repetitively. Clinical responses were observed in 18% of those with follicular lymphomas, and 65% of these patients exhibited either response or stable disease.