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Home » HUMAN GENOME SCIENCES REPORTS PHASE II RESULTS FOR HGS-ETR1
HUMAN GENOME SCIENCES REPORTS PHASE II RESULTS FOR HGS-ETR1
July 6, 2005
Human Genome Sciences announced that the results of a Phase II clinical trial demonstrate that HGS-ETR1 (mapatumumab) is well-tolerated and can be administered safely in patients with advanced non-small cell lung cancer (NSCLC).
Data on 32 patients were presented in at the 11th World Conference on Lung Cancer in a poster entitled "Results of a Phase II Trial of HGS-ETR1 (Agonistic Human Monoclonal Antibody to TRAIL Receptor 1) in Subjects with Relapsed/Recurrent Non-Small Cell Lung Cancer." The trial, which was conducted in the U.S., was a multicenter, open-label study to evaluate the efficacy, safety and tolerability of HGS-ETR1 in patients with relapsed or refractory non-small cell lung cancer.
Patients enrolled in the trial received 10 mg/kg doses of HGS-ETR1 administered as an intravenous infusion 21 days apart in the absence of disease progression. The primary objective of the study was to evaluate tumor response. The secondary objectives were to evaluate the safety and tolerability of HGS-ETR1, and to determine plasma concentrations of HGS-ETR1 for use in a population pharmacokinetic analysis.
Patients participating in the study had previously received up to seven different cancer treatment regimens (median of three). The data presented demonstrated that HGS-ETR1 was well tolerated, with no patients discontinuing therapy due to drug-related toxicity, and that HGS-ETR1 can safely be administered intravenously every 21 days at doses of 10 mg/kg. No immunogenic responses were observed. Stable disease was observed in 29 percent of the patients treated, with eight patients receiving at least four cycles of therapy.
KEYWORDS Drug Pipeline Alert
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