Seattle Genetics is announcing the initiation of a phase II clinical trial that will evaluate their antibody drug conjugate Adcetris (brentuximab vedotin) as a potential front-line therapy for patients age 60 or older with newly diagnosed Hodgkin's lymphoma (HL).
This trial is designed to assess the efficacy and tolerability of Adcetris as a solo or monotherapy for this older group of HL patients who are treatment naive.
Adcetris is currently approved for the treatment of relapsed HL and systemic anaplastic large cell lymphoma (sALCL).
"The current standard of care for the treatment of front-line HL is a combination of multiple chemotherapeutic agents and has not changed in more than three decades," said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer at Seattle Genetics, referring to ABVD chemotherapy.
"Some older HL patients are not able to tolerate the significant side effects associated with these regimens, and there is a significant need to identify effective and tolerable treatment options for these patients."
This is a phase II single-arm, open-label clinical trial, enrolling newly diagnosed and treatment naive patients.
The primary endpoint is the objective response rate (ORR).
Secondary endpoints include safety and tolerability, duration of response, complete remission (CR) rate and progression-free survival (PFS).
Source: Seattle Genetics