Brentuximab Vedotin (SGN-35) blijkt een zo succesvolle aanpak van non-Hodgkin lymfomen dat er een tekort aan het ontstaan is aan dit medicijn. Zo meldt de Volkskrant  vandaag in een pagina groot artikel. Ik heb de studie er eens bijgehaald die recent nog is gepubliceerd in het NEJM (New England Journal of Medicin) en de resultaten lijken inderdaad veelbelovend. Maar het is nog slechts een fase I/II studie. Op de website van Seattle Genetics  staat meer over lopende studies met dit middel. Een eerste studie was al snel compleet maar kunt u wellicht ook informatie opvragen: Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

Hier het abstract van de studie. Als u het volledige studierapport wilt lezen klik hier, het is vrij te lezen.

Brentuximab Vedotin (SGN-35) for Relapsed CD30-Positive Lymphomas

Anas Younes, M.D., Nancy L. Bartlett, M.D., John P. Leonard, M.D., Dana A. Kennedy, Pharm.D., Carmel M. Lynch, Ph.D., Eric L. Sievers, M.D., and Andres Forero-Torres, M.D.

N Engl J Med 2010; 363:1812-1821November 4, 2010


Hodgkin's lymphoma and anaplastic large-cell lymphoma are the two most common tumors expressing CD30. Previous attempts to target the CD30 antigen with monoclonal-based therapies have shown minimal activity. To enhance the antitumor activity of CD30-directed therapy, the antitubulin agent monomethyl auristatin E (MMAE) was attached to a CD30-specific monoclonal antibody by an enzyme-cleavable linker, producing the antibody–drug conjugate brentuximab vedotin (SGN-35).


In this phase 1, open-label, multicenter dose-escalation study, we administered brentuximab vedotin (at a dose of 0.1 to 3.6 mg per kilogram of body weight) every 3 weeks to 45 patients with relapsed or refractory CD30-positive hematologic cancers, primarily Hodgkin's lymphoma and anaplastic large-cell lymphoma. Patients had received a median of three previous chemotherapy regimens (range, one to seven), and 73% had undergone autologous stem-cell transplantation.


The maximum tolerated dose was 1.8 mg per kilogram, administered every 3 weeks. Objective responses, including 11 complete remissions, were observed in 17 patients. Of 12 patients who received the 1.8-mg-per-kilogram dose, 6 (50%) had an objective response. The median duration of response was at least 9.7 months. Tumor regression was observed in 36 of 42 patients who could be evaluated (86%). The most common adverse events were fatigue, pyrexia, diarrhea, nausea, neutropenia, and peripheral neuropathy.


Brentuximab vedotin induced durable objective responses and resulted in tumor regression for most patients with relapsed or refractory CD30-positive lymphomas in this phase 1 study. Treatment was associated primarily with grade 1 or 2 (mild-to-moderate) toxic effects. (Funded by Seattle Genetics; number, NCT00430846.)


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