Brentuximab Vedotin (SGN-35), an antibody-drug conjugate that targets CD30 was found to shrink tumors in 75% of 102 patients with relapsed or refractory Hodgkin lymphoma in a pivotal trial. Brentuximab Vedotin was developed by Seattle Genetics Inc. and The Takeda Oncology Company, part of Takeda Pharmaceutical Company Limited.

Researchers say that the median duration of response was greater than six months, i.e. the benefit of the therapy lasted at least six months. The safety of brentuximab vedotin was generally about the same in this clinical trial as in previous ones.

Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics, said:

We are extremely excited with the top-line results, as they move us one step closer to our goal of bringing brentuximab vedotin to patients with relapsed or refractory Hodgkin lymphoma. We are positioned for a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) in the first half of 2011. In addition, we plan to report top-line data from our phase II trial of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) within the next few weeks.

Nancy Simonian, M.D., Chief Medical Officer of Millennium, said:

The lack of adequate therapies for the treatment of relapsed and refractory Hodgkin lymphoma represents a substantial unmet medical need worldwide, with almost a third of the 30,000 newly diagnosed patients relapsing or becoming refractory to front-line therapy annually. These data have the potential to provide an important advance in therapy for Hodgkin lymphoma. We intend to discuss these results with European regulators to support our goal of submitting a Marketing Authorization Application to the European Medicines Agency (EMA) in 2011.

The trial involved 102 patients with advanced lymphoma who had not responded to previous treatments. They received 1.8 milligrams per kilogram of brentuximab vedotin once every three weeks for up to 16 doses. 75% of patients experienced shrinking tumors. Those who experienced benefits did so for at least six months, the researchers reported.

Lymphoma is a type of cancer that starts in the lymphocytes, which are immune system cells. As in other cancers, lymphoma occurs when lymphocytes are in a state of uncontrolled cell growth and multiplication.

Lymphocytes are white blood cells that travel throughout the body in a fluid called lymph. They are transported by a network of vessels that make up the lymphatic system, part of the immune system. The lymphatic system – whose job it is to combat infections or anything else that threatens the body – is also comprised of lymph nodes that exist throughout the body to filter the lymph that flows through them. The lymph nodes become inflamed and tenderize when a large number of microbial organisms collect inside of them, indicating local infection.

There are two primary types of lymphocytes: B cells and T cells. Both are designed to identify and destroy infections and abnormal cells. B cells produce proteins that travel throughout the body, attaching themselves to infectious organisms and abnormal cells and alerting the immune system that the pathogen needs to be destroyed. T cells actually kill the pathogens directly and serve a function in regulating the immune system from over- or under-activity.

Lymphoma occurs when lymphocyte B or T cells change and begin growing and multiplying uncontrollably.

There are two types of lymphoma: Hodgkin lymphoma (HL, also called Hodgkin’s disease) and non-Hodgkin lymphoma (NHL). Both HL and NHL can occur in the same places and have similar symptoms. Their differences are visible at a microscopic level.

Hodgkin lymphoma develops from a specific abnormal lineage of B cells. There are five subtypes of HL. NHL may derive from either abnormal B or T cells, and its 30 subtypes are distinguished by unique genetic markers. The large number of lymphoma subtypes has led to a complicated classification scheme that involves microscopic appearance and well-defined genetic and molecular configurations.

Click here to read about Lymphoma in more detail.

Source: Seattle Genetics Inc.

Written by Christian Nordqvist