HOUSTON ― An antibody loaded with an anti-cancer agent produced complete or partial remissions in 38 percent of patients with relapsed or therapy-resistant Hodgkin lymphoma enrolled in a phase I clinical trial, investigators report in the Nov. 4 issue of the New England Journal of Medicine.
"That level of objective responses to a drug is impressive for a Phase I trial," said study lead author Anas Younes, M.D., professor in The University of Texas MD Anderson Cancer Center's Department of Lymphoma/Myeloma. "These encouraging results are being confirmed in a large phase II trial, the results of which are expected to be released in December.
"There hasn't been a new drug considered for Hodgkin lymphoma in 30 years," Younes said. "The potential impact on years of life saved is huge because the median age for this disease is only 32."
Phase I trials are mainly designed to find a maximum tolerated dose for an investigational therapy and to determine the type and severity of side effects that may accompany a drug. They enroll patients who have received standard treatments and have no other therapeutic options.
Brentuximab vedotin (SGN-35), the drug used in the clinical trial, consists of an antibody that targets the CD30 cell surface protein attached to a drug that blocks a class of proteins crucial to cell division. CD30 is expressed on Hodgkin lymphoma and anaplastic large-cell lymphoma (ALCL) cells, Younes said, with normal expression limited to about 1 percent of T cells and other immune system components.
A total of 45 patients enrolled, 42 with Hodgkin lymphoma, two with ALCL and one with angioimmunoblastic T-cell lymphoma. They had undergone a median of three previous chemotherapy regimens and 73 percent had received blood stem cell transplants.
The investigators determined a maximum-tolerated intravenous dose of 1.8 mg per kilogram of body weight every three weeks. Side effects at that dose w
|Contact: Scott Merville|
University of Texas M. D. Anderson Cancer Center