Seattle Genetics, Inc. (SGEN) announced data from a two-year durability analysis of a phase I study on Adcetris (in combination with CHP chemotherapy) for the treatment of patients newly diagnosed with CD30-positive peripheral T-cell lymphoma (PTCL) (also known as mature T-cell lymphoma, or MTCL).
Patients, who achieved at least partial remission after completing six cycles (each three week long) of the combination therapy, were further treated with single-agent Adcetris for up to ten additional three-week cycles. The primary endpoints of the study were to define the maximum tolerated dose of Adcetris in combination with CHP regimen and evaluate its safety.
We note that Adcetris is in four phase III studies − AETHERA (Hodgkin lymphoma patients who are at high risk of relapse following autologous stem cell transplant (ASCT)), ALCANZA (relapsed cutaneous T-cell lymphoma (CTCL)), ECHELON-1 (front-line advanced classical Hodgkin lymphoma) and ECHELON-2 (front-line CD30-positive MTCL, including systemic anaplastic large cell lymphoma (sALCL)).
Data from the phase I study in newly diagnosed CD30-positive MTCL patients with advanced or high-risk disease characteristics showed durable progression-free survival (PFS) and overall survival (OS) rates. The estimated two-year PFS rate in this study was 54% while the OS rate was 80%. This data supported the ongoing phase III ECHELON-2 study, in which patients are currently being enrolled.
Seattle Genetics will present the phase I data at the European Society for Medical Oncology (ESMO) Congress to be held from Sep 26 to Sep 30.
Seattle Genetics has accelerated approval for Adcetris in the U.S. and conditional approval in Canada for two indications − Hodgkin lymphoma after failure of ASCT or after failure of at least two prior multi-agent chemotherapy regimens in non-ASCT patients and sALCL after failure of at least one prior multi-agent chemotherapy regimen.
In Europe, Seattle Genetics has conditional marketing authorization for Adcetris for relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option and relapsed or refractory sALCL.
Seattle Genetics holds a Zacks Rank #2 (Buy). Some better-ranked stocks in the biotech sector include Amgen Inc. (AMGN), Regado Biosciences, Inc. (RGDO) and Gilead Sciences Inc. (GILD). All these stocks carry a Zacks Rank #1 (Strong Buy).
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