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Genmab, GSK CLL Drug Sails Through Pivotal Test
(BioWorld Today Via Acquire Media NewsEdge) Genmab A/S and partner GlaxoSmithKline plc said their investigational leukemia drug ofatumumab convincingly passed its Phase III pivotal study, meeting the primary endpoint in both patient groups studied.
Ofatumumab (HuMax-CD20), a new generation fully human monoclonal antibody that targets the small loop epitope of the CD20 molecule on B cells, gained an objective response of 51 percent in one group - double what was hoped for - and reached a 44 percent objective response in the other group.
In the interim analysis, ofatumumab was evaluated in one group of 154 chronic lymphocytic leukemia (CLL) patients, 138 of whom were evaluable. About half of the patients (59) were refractory to both fludarabine and alemtuzumab. The analysis also included a second group (79) who were refractory to fludarabine and considered inappropriate candidates for alemtuzumab due to bulky tumor in their lymph nodes.
An objective response rate of 51 percent (p < 0.0001), consisting of 30 partial responses, was achieved in the group of patients refractory to fludarabine and alemtuzumab. In the fludarabine refractory, alemtuzumab inappropriate patient group, an objective response rate of 44 percent (p < 0.0001) was achieved, including one complete response, and 34 partial responses.
All patients in the ongoing study receive eight weekly infusions of ofatumumab, followed by four monthly infusions. Patients receive 300 mg at the first infusion and 2,000 mg at each subsequent infusion. Disease status is assessed every four weeks until week 28 and then every three months until disease progression or month 24. Patient recruitment is continuing, and Genmab said a final analysis will be conducted on the full study population, which is expected to be 100 patients in each group.
Ofatumumab was generally well tolerated, with the most frequent adverse events being pyrexia, diarrhea, fatigue, cough, neutropenia, anemia and pneumonia. There were no unexpected safety findings. None of the 14 patients tested for human anti-human antibodies (HAHA) demonstrated their presence at 12 months.
Genmab, of Copenhagen, Denmark, said it has requested a pre-biologics license application meeting with the FDA to discuss the data, and it is targeting a 2008 BLA filing.
There also is the potential to submit to the EU regulatory authorities in this time frame. Full data will be submitted to a future scientific meeting.
London-based GSK in-licensed ofatumumab in a deal valued at up to $2.1 billion in December 2006. (See BioWorld Today, Dec. 20, 2006.) It has a similar mode of action to rituximab (Rituxan, Mabthera), which is co-marketed in the U.S. by Cambridge, Mass.-based Biogen Idec and South San Francisco-based Genentech Inc., and in Europe by Basel, Switzerland-based F. Hoffmann-La Roche Ltd. It differs, however, in being a fully human antibody whereas rituximab is a chimeric antibody, a distinction that Genmab thinks could have a difference in chronic treatment settings.
Ofatumumab also is in various Phase II and Phase III studies in non-Hodgkin's lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis, all in partnership with GSK.
On Thursday, shares in Genmab on the Copenhagen Stock Exchange (CSE:GEN) gained DKK31 (US$6.48) to close at DKK257. n
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