Human Genome says phase 2 trial of HGS-ETR1 shows clinical responses for non-Hodgkin's lymphoma

New York, Dec. 12 - Human Genome Sciences, Inc. said that a phase 2 clinical trial of HGS-ETR1 (mapatumumab) showed the drug is well tolerated and capable of producing clinical responses when administered as monotherapy in patients with advanced non-Hodgkin's lymphoma.

"These clinical results build on a growing body of preclinical evidence that HGS-ETR1 can induce cell death in a wide variety of cultured lymphoma and leukemia patient samples and cultured cell lines," said Anas Younes, professor of lymphoma/myeloma at University of Texas M.D. Anderson Cancer Center in Houston, in a press release.

The results were presented at the 47th annual meeting of the American Society of Hematology in Atlanta.

The phase 2 trial is a multi-center, open-label study to evaluate the efficacy, safety and tolerability of HGS-ETR1, an agonistic human monoclonal antibody to Trail receptor 1, in patients with relapsed or refractory non-Hodgkin's lymphoma.

The 40 patients enrolled in the trial received up to six cycles of treatment in the absence of disease progression, with HGS-ETR1 administered as an intravenous infusion once every 21 days. Patients were enrolled in two groups, with eight patients receiving HGS-ETR1 doses of 3 mg/kg and 32 receiving HGS-ETR1 doses of 10 mg/kg.

Patients participating in the study were heavily pretreated, having received up to 12 previous cancer treatment regimens, with 69% (28 out of 40) having received 3 or more prior regimens. Of note, 94% (34 out of 36) of the subjects with B-cell non-Hodgkin's lymphoma had received prior rituximab therapy.

The reported data showed HGS-ETR1 is well tolerated, with minimal toxicity, can safely be administered intravenously every 21 days at doses up to 10 mg/kg, and exhibits clinical activity in patients with relapsed or refractory non-Hodgkin's lymphoma.

Three patients showed responses, one complete and two partial, all of whom had been diagnosed with follicular lymphomas.

Stable disease was observed in 30% or 12 out of 40 of the patients.

So far, seven patients or 18% remain without progression of disease, with stable disease or response enduring nine to 18 months.

Two patients received special permission to continue treatment until progression. One received 12 cycles of treatment, while the other received more than nine.

In addition, a poster presentation of the results from pre-clinical studies showed that HGS-ETR1 with rituximab showed better in vitro inhibition of non-Hodgkin's lymphoma cell growth than either HGS-ETR2 with rituximab or rituximab alone.

Human Genome Sciences is a Rockville, Md., biotechnology company.

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