Millennium, part of the Takeda Group, has announced the interim results from a Phase I clinical trial of Adcetris (brentuximab vedotin) administered in combination with or sequentially with chemotherapy to treat newly diagnosed systemic anaplastic large cell lymphoma (sALCL) and other CD30-positive mature T-cell lymphoma patients.
Jointly developed by Seattle Genetics and Millennium, Adcetris is an antibody-drug conjugate, consisting of an anti-CD30 monoclonal antibody linked by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E, using Seattle Genetics' proprietary technology.
The Phase I trial enrolled 32 patients, of which 30 patients had sALCL, one patient had peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), and one patient had human T-cell lymphotropic virus (HTLV)-1 associated T-cell lymphoma.
In the study, patients were administered with two sequential treatment regimen comprising two cycles of single-agent Adcetris every three weeks at 1.8mg/kg, followed by six cycles of CHOP.
The trial reported that patients who achieve at least a partial remission (PR) after completing the six cycles of CHOP are eligible to receive continued single-agent Adcetris at 1.8mg/kg for up to an additional eight three-week cycles.
The primary objectives of the trial include dose-limiting toxicities, safety and tolerability of Adcetris when combined or used sequentially with multi-agent front-line chemotherapy regimens, while the secondary endpoints are investigator assessment of response, progression-free survival (PFS) and overall survival (OS).
The University of Texas MD Anderson Cancer Center Division of Cancer Medicine Department of Lymphoma / Myeloma professor Michelle Fanale said: "The interim data from this phase I clinical trial suggest that ADCETRIS has the potential to play an important role in advancing the treatment of newly diagnosed T-cell lymphoma patients, and continued investigation of ADCETRIS in these patients is warranted."
In August 2011, Adcetris was granted accelerated approval by the US Food and Drug Administration (FDA) for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) and for the treatment of patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen.
As per the collaboration agreement, Seattle Genetics has gained US and Canadian commercialisation rights, and the Takeda Group has rights to commercialise the drug in the rest of the world.