Genmab A/S (CSE: GEN) announced today final data from its two Phase II studies in early and late stage mycosis fungoides (MF)
COPENHAGEN, Denmark | June 29, 2007 | Genmab A/S (CSE: GEN) announced today final data from its two Phase II studies in early and late stage mycosis fungoides (MF), a form of cutaneous T-cell lymphoma (CTCL), was reported in Blood (Kim, Y., M. Duvic, E. Obitz, et al. Clinical efficacy of zanolimumab (HuMax-CD4): two phase 2 studies in refractory cutaneous T-cell lymphoma. Blood 2007; 109: 4655-4662). In the high dose levels of 560 mg and 980 mg, 13 MF patients had objective responses lasting between 8 and 91 weeks, with median response duration of 81 weeks (20.3 months), a significant increase compared to previously reported data. Nine of the responses lasted more than 20 weeks. Three MF patients treated at the 280 mg dose had responses lasting 12, 13 and 24 weeks and discontinued the study before disease progression.
Responses generally remained the same with 13 of 38 MF patients overall obtaining an objective response to HuMax-CD4 (zanolimumab). Fifty-six percent of MF patients treated at 560 mg (7/14 patients) or 980 mg (3/4 patients) of HuMax-CD4 achieved objective responses compared with 15% at the 280 mg (3/20 patients) dose when evaluated by CA Score.
“The final data from the Phase II CTCL studies shows the duration of response nearly doubled the duration of 10.5 months we previously reported,” said Lisa N. Drakeman, Ph.D. “We believe this length of duration could be a significant advantage for CTCL patients who must often return to their doctors seeking new treatments after short periods of time.”
About the Studies
Two studies were conducted concurrently – one in early stage CTCL and one in late stage. In both studies, patients were refractory or intolerant to previous therapy and were treated with a 280 mg, 560 mg or 980 mg dose of Humax-CD4 once a week for 16 weeks. Patients were followed for at least 4 weeks after the end of treatment or until disease progression. Objective responses were evaluated using the Composite Assessment of Index Lesion Disease Activity (CA) Score.
SOURCE: Genmab A/S
Post Views: 138
Genmab A/S (CSE: GEN) announced today final data from its two Phase II studies in early and late stage mycosis fungoides (MF)
COPENHAGEN, Denmark | June 29, 2007 | Genmab A/S (CSE: GEN) announced today final data from its two Phase II studies in early and late stage mycosis fungoides (MF), a form of cutaneous T-cell lymphoma (CTCL), was reported in Blood (Kim, Y., M. Duvic, E. Obitz, et al. Clinical efficacy of zanolimumab (HuMax-CD4): two phase 2 studies in refractory cutaneous T-cell lymphoma. Blood 2007; 109: 4655-4662). In the high dose levels of 560 mg and 980 mg, 13 MF patients had objective responses lasting between 8 and 91 weeks, with median response duration of 81 weeks (20.3 months), a significant increase compared to previously reported data. Nine of the responses lasted more than 20 weeks. Three MF patients treated at the 280 mg dose had responses lasting 12, 13 and 24 weeks and discontinued the study before disease progression.
Responses generally remained the same with 13 of 38 MF patients overall obtaining an objective response to HuMax-CD4 (zanolimumab). Fifty-six percent of MF patients treated at 560 mg (7/14 patients) or 980 mg (3/4 patients) of HuMax-CD4 achieved objective responses compared with 15% at the 280 mg (3/20 patients) dose when evaluated by CA Score.
“The final data from the Phase II CTCL studies shows the duration of response nearly doubled the duration of 10.5 months we previously reported,” said Lisa N. Drakeman, Ph.D. “We believe this length of duration could be a significant advantage for CTCL patients who must often return to their doctors seeking new treatments after short periods of time.”
About the Studies
Two studies were conducted concurrently – one in early stage CTCL and one in late stage. In both studies, patients were refractory or intolerant to previous therapy and were treated with a 280 mg, 560 mg or 980 mg dose of Humax-CD4 once a week for 16 weeks. Patients were followed for at least 4 weeks after the end of treatment or until disease progression. Objective responses were evaluated using the Composite Assessment of Index Lesion Disease Activity (CA) Score.
SOURCE: Genmab A/S
Post Views: 138
