Experimental drug Brentuximab Vedotin (SGN-35) achieved tumor volume reductions in 94% of Relapsed or Refractory Hodgkin Lymphoma patients while 34% of them achieved complete remission, Seattle Genetics reported after completing a Pivotal Clinical Trial. The company expects to submit the medication to the FDA (Food and Drug Administration) for approval during the first quarter of 2011 and to European regulators during the first half of 2011.

Brentuximab vedotin is an ADC (antibody-drug conjugate). It targets a defining marker of Hodgkin lymphoma – CD30. Presenters explained the results of the trial at the 52nd American Society of Hematology (ASH) Annual Meeting in Orlando, Florida.

The pivotal trial involving 102 patients with relapsed or refractory Hodgkin lymphoma achieved:

  • 75% of patients achieved the primary endpoint of the trial
  • Complete remission was acheived in 34% of patients
  • Independent central review confirmed a 29 week median response, and 47 weeks by investigator assessment
  • Median duration of response among complete remission patients had not been reached at a median 1-year follow-up
  • 94% of all patients experienced tumor reductions

The company reports that adverse events were manageable, and included peripheral sensory neuropathy, nausea, diarrhea, upper respiratory tract infection, nausea and fatigue.

Dr. Robert Chen, Assistant Professor, Hematology & Hematopoietic Cell Transplantation at City of Hope, said:

    “Up to thirty percent of all patients diagnosed with Hodgkin lymphoma will relapse. These patients have limited treatment options beyond autologous stem cell transplantation and represent a significant unmet medical need. Based on these data, brentuximab vedotin has the potential to change the treatment paradigm for relapsed or refractory Hodgkin lymphoma patients, and could be the first treatment approved for these patients in more than 20 years.”

Dr. Andreas Engert, Professor of Internal Medicine, University of Cologne, Germany, said:

    “I have rarely seen such response rates in this relapsed or refractory disease population. These data highlight brentuximab vedotin as a potential addition to the treatment options for Hodgkin lymphoma patients.”

A BLA (Biologics License Application) in the USA is planned for the beginning of 2011 for both relapsed or refractory Hodgkin lymphoma and relapsed/refractory ALCL (systemic anaplastic large cell lymphoma).

An MAA (Marketing Authorization Application) submission to EMA (European Medicines Agency) is planned for the first half of 2011.

Lymphoma is a kind of cancer that starts in the lymphatic system, specifically, the lymphocytes (immune cells). The lymphocytes are in a state of uncontrolled cell growth and multiplication. Lymphocytes are white blood cells that move throughout the body in a fluid called lymph. They travel through a network of vessels – the lymphatic system, which is part of our immune system.

There are two types of lymphoma: Hodgkin lymphoma, also called Hodgkin’s disease or simply HL, and non-Hodgkin lymphoma (NHL). Both types can develop in the same places and have similar signs and symptoms. Their differences are detectable at a microscopic level. HL develops from a specific abnormal lineage of B cells. HL has five subtypes. NHL can come from either abnormal B or T cells – there are 30 subtypes of NHL and they are distinguished by unique genetic markers.

According to Seattle Genetics:

    “Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. A defining attribute of the Reed-Sternberg cell is its expression of the CD30 antigen.”

By the end of this year about 8,500 Hodgkin lymphoma diagnoses will be made in the USA, and over 1,300 patients will have died from the disease, says the American Cancer Society. Over 30,000 individuals are diagnosed with the disease worldwide annually.

Seattle Genetics and Millennium are jointly developing brentuximab vedotin. Seattle Genetics has US/Canadian marketing rights for the medication while the Takeda Group has commercialization rights for the rest of the world. The Takeda Group is solely responsible for brentuximab vedotin’s development costs in Japan, and Seattle Genetics and Takeda share the costs 50/50 in the rest of the world.

Soucre: Seattle Genetics

Written by Christian Nordqvist