to seek approval for the product in Europe in 2011. “These data have the potential to provide an important advance in therapy for Hodgkin lymphoma,” said Millennium’s chief medical officer, Nancy Simonian, in a statement.
The trial, which started in February 2009, was designed in collaboration with the FDA. All patients got the treatment, rather than being randomly assigned to either the standard of care or the new drug. They were given an intravenous infusion of the Seattle Genetics treatment every three weeks. Side effects were mostly mild, and similar to what researchers saw in a preliminary trial: mild tingling and numbness in the fingers and toes, fatigue, white blood cell depletion, and diarrhea. All patients had relapsed after prior therapy and generally had a life expectancy of two to three years.
Seattle Genetics—partly to give its investigators a chance to show the full details at medical conference to be determined—isn’t providing important details yet about how many of the patients had complete disappearance of their tumors and how many just had partial responses. But when Seattle Genetics’ executive team got a look at the data over the weekend, it confirmed what they thought they’d see, given results from a Phase I trial. Back in a story I wrote two years ago, chief medical officer Tom Reynolds said brentuximab vedotin offered the kind of groundbreaking results for a cancer drug that are rarely seen, likening it to Roche and Biogen Idec’s rituximab (Rituxan) for non-Hodgkin’s lymphoma and Novartis’ imatinib (Gleevec) for chronic myeloid leukemia. Yesterday, Siegall had the same reaction.
“When the data was put up on screen, excitement was palpable,” Siegall says. “It was incredibly exciting for us. We work incredibly hard and are passionate about what we do. I can’t tell you how gratifying it is to see that kind of result. Very few agents demonstrate this type of response rate.”
More news is to come on whether this drug can help patients earlier on or with similar diseases. Seattle Genetics plans to release more clinical trial data within a few weeks on whether brentuximab vedotin can help patients with another rare lymphoma, anaplastic large cell lymphoma, that also has an overabundant number of CD30 cell markers, like Hodgkin’s. And while many patients with Hodgkin’s are essentially cured today by prior rounds of chemotherapy, Seattle Genetics and Millennium envision bringing this new antibody therapy to larger numbers of patients with earlier forms of disease because of the new drug’s combination of strong effectiveness and mild side effects. One such trial, called Aethera, is currently enrolling more than 320 patients.
Seattle Genetics hasn’t set a price for this product, but it has discussed
