in clinical trials were a depletion in infection-fighting white blood cells, nerve damage in the fingers and toes, fatigue, nausea, and anemia. But most of the side effects were mild by cancer drug standards and the response rate was extraordinary given this group of patients had essentially run out of options, and entered the trial with a life expectancy of two to three years.
One of the key studies to watch on whether Seattle Genetics can take this drug to a larger group of Hodgkin’s patients will be presented Dec. 13 by Anas Younes of the University of Texas MD Anderson Cancer Center in Houston. That study was designed to enroll first-line Hodgkin’s patients on either the usual ABVD plus Adcetris in a variety of doses, or just AVD plus Adcetris.
Interim results, posted on the ASH website, show that six of 31 patients dropped out because of side effects, and that seven patients had to quit taking bleomycin because of side effects. Five of those seven patients were able to continue taking the Seattle Genetics drug along with AVD, researchers said. No patients died in the study, but researchers did say that 16 percent of patients had febrile neutropenia, which means patients had a significant depletion of their infection-fighting white-blood cells, combined with a fever.
Researchers labeled the side effects of the experimental regimen as “manageable” in the abstract. More updated data on safety, and the drug’s anti-tumor effect, will be made available at the meeting.
The data being presented next week at ASH is still interim, Siegall says, but there’s already enough information at this point for Seattle Genetics and Millennium to plan the next major step. That will be a global study of more than 880 patients getting first-line treatment for Hodgkin’s disease, Siegall says. The companies are still working on designing the study protocol, and signing up clinical trial sites around the world, but the goal is to start enrolling patients by the end of 2012 or early 2013, Siegall says. The upcoming study will be from the third of three phases of clinical trials normally required for FDA approval.
Siegall made it clear that moving Adcetris to first-line Hodgkin’s lymphoma is just the beginning of a broader program to bring the new drug to more patients.
“This is the pathway Rituxan went down,” Siegall says. “They started with relapsed, refractory patients. Then they went to front line patients, and then additional lymphomas.”
