l auristatin E (MMAE).
Seattle Genetics and its Adcetris collaborator, Millennium, are conducting the ALCANZA trial, a Phase 3 clinical trial of Adcetris for patients with CD30-positive relapsed CTCL, including those with primary cutaneous anaplastic large cell lymphoma (pcALCL) or MF. The trial is assessing Adcetris vs. investigator's choice of methotrexate or bexarotene (Targretin; Eisai). The primary endpoint of the study is overall response rate lasting at least 4 months. Approximately 124 patients will be enrolled in the pivotal trial.
Adcetris is approved for two indications: (1) the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.
August 22, 2011
Adcetris Approved for Hodgkin lymphoma and Systemic Anaplastic Large Cell Lymphoma
Adcetris Approved for Hodgkin lymphoma and Systemic Anaplastic Large Cell Lymphoma The FDA approved Adcetris (brentuximab vedotin; Seattle Genetics) to treat Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL). Adcetris is to be used in patients with HL whose disease has progressed after autologous stem cell transplant or after two prior chemotherapy treatments for those who cannot receive a transplant. Adcetris may also be used in patients with ALCL whose disease has progressed after one prior chemotherapy treatment.
The effectiveness of Adcetris in patients with HL was eva luated in a single clinical trial involving 102 patients. In the single-arm trial, patients were only treated with Adcetris. The study's primary endpoint was objective response rate, the percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment. Seventy-three percent of patients achieved either a complete or partial response to the treatment. On average, these patients responded to the therapy for 6.7 months.
The effectiveness of Adcetris in patients with systemic ALCL was eva luated in a single clinical trial in 58 patients. In the single-arm trial, patients were only treated with Adcetris. The trial's primary endpoint was objective response rate. Of the patients receiving Adcetris for ALCL, 86% experienced either a complete or partial response and responded on average for 12.6 months.
Phase 2 Trial Update of Adcetris in Cutaneous T-Cell Lymphoma
Seattle Genetics announced interim results from a Phase 2 clinical trial of Adcetris (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL).
At the time of data analysis, 17 of 23 enrolled patients had received at least two doses of Adcetris and were eva luable for response. All patients had relapsed CD30-positive cutaneous lymphoproliferative disorders, including lymphomatoid papulosis, primary cutaneous anaplastic large cell lymphoma or mycosis fungoides. Patients treated in this trial receive 1.8mg/kg of Adcetris every three weeks for up to a maximum of eight doses. Patients who achieve partial remission or stable disease are eligible to receive an additional eight doses. Eleven of 17 eva luable patients (65%) achieved an objective response, including seven complete remissions and four partial remissions. Six patients had stable dise |
