Danish biotech company Genmab, which sold the global rights to its HuMax-CD20 (a.k.a. ofatumumab) antibody to GlaxoSmithKline (GSK) for over DKK 12bn (USD 2.5bn) in 2007, has just announced the long-awaited results of a Phase III study of the drug in the treatment of chronic lymphocytic leukaemia (CLL), reports financial daily newspaper Børsen.
The top-line results make very encouraging reading: the study in 154 patients showed positive response rate of 51% in the patient group refractory (i.e. non-responsive) to fludarabine and alemtuzumab, and 44% in the patient group refractory to fludarabine and for whom alemtuzumab treatment would be inappropriate. The health authorities set the bar for acceptable response rate at 25%. Genmab shares rose sharply on the news.
Genmab now plans to file for approval for the drug in both the US and Europe. In the US, the FDA has previously given Genmab fast-track status, which means that the authorities can process marketing applications within six months.
"We are thrilled to report a positive outcome for the CLL patients in this trial," said Genmab CEO Lisa Drakeman in a press release. "This also represents a significant achievement for Genmab as we now move toward filing of the first marketing applications for a Genmab antibody and we look forward to working with GSK on the submissions."
Kathy Rouan, vice president at GSK, said: "These very encouraging results suggest that ofatumumab has the potential to provide benefits to CLL patients with very refractory disease and limited treatment options." Rouan added that GSK and Genmab are collaborating on other pipeline drug development programmes.
Genmab creates and develops human antibodies for the treatment of life-threatening and debilitating diseases. The company has a portfolio of products in development to treat cancer, rheumatoid arthritis, infectious diseases and other inflammatory conditions. Genmab is listed on the OMX Nordic Exchange Copenhagen.