Takeda antibody drug adcetris submits a new adaptation application for peripheral T-cell lymphoma (PTCL).

Seattle Genetics and partner Takeda recently jointly announced that they have submitted to the U.S. Food and Drug Administration (FDA) a supplemental biologics license (sBLA) for the antibody drug adcetris, which is used for CD30-positive peripheral T-cell lymphoma (PTCL, also known as mature T-cell lymphoma, MTCL).
sBLA submission is based on data from Phase III clinical study ECHELON-2. The study was the largest randomized, double-blind Phase III study ever conducted in PTCL patients, which included previously untreated CD30-positive PTCL patients, and assessed the efficacy and safety of Adcetris combined chemotherapy program CHP (cyclophosphamide-amycin-strong pine) for first-line treatment compared to the currently recognized first-line standard care plan CHOP (cyclophosphamide-amoelin-synthesium-strong pine) for first-line treatment. The main endpoint of the study was the progress-free lifetime (PFS) assessed by the Independent Review Body (IRF).
results show that compared with the CHOP scheme, the Adcetris-CHP scheme has achieved a significant statistical improvement in PFS (HR=0.71, p=0.0110), which has reached the main end of the study. In addition, compared to the CHOP scheme, the Adcetris-CHP scheme also shows advantages in terms of total lifetime (OS) at the critical secondary endpoint (HR=0.66, p=0.0244). Other key secondary endpoints, the Adcetris-CHP programme also showed significant statistically significant advantages, including PFS in patients with systemic degenerative large cell lymphoma (sALCL), complete remission rate (CRR), and objective remission rate (ORR). In this study, the Adcetris-CHP scheme is similar to the CHOP scheme. Detailed figures will be released at the annual meeting of the American Society of Hematology (ASH) in early December.
. Clay Siegall, president and CEO of Seattle Genetics, said CD30 is expressed in several subtypes of PTCL, an invasive non-Hodgkin's lymphoma (NHL) that diagnoses about 4,000 CD30-positive patients in the United States each year. For decades, the multidring chemotherapy program CHOP has been the standard first-line treatment treatment for PTCL. The results from the ECHELON-2 study show that when used in CD30-positive PTCL first-line treatment, the Adcetris joint CHP program significantly improved the therapeutic effect compared to the CHOP program, which is a major breakthrough in CD30-positive PTCL treatment. We look forward to working with the FDA to bring this innovation to patients as soon as possible.
Adcetris is an antibody-coupled drug (ADC) made from a monoclonal antibody that targets cd30 proteins and a micro-tube destroyer (monomethyl auristatin E, MMAE) that is coupled with a protease-sensitive crosslinking agent, a proprietary technique of Seattle Genetics. Cd30 protein is a clear marker of classic Hodgkin's lymphoma (HL) and systemic interdessional large cell lymphoma (sALCL), while Auristatin E prevents cell division by inhibiting the polymerization of micro-tube proteins. Adcetris is stable in the blood and releases MMAE after being internalized by CD30-positive tumor cells.
, developed by Seattle Genetics, reached a licensing agreement in 2009 to commercialize the drug in other countries around the world, except the United States and Canada. To date, Adcetris has been ratified by more than 70 countries worldwide.
Currently, Takeda and Seattle Genetics are actively pursuing a large Phase III clinical development project aimed at turning Adcetris into a basic care drug for CD30-positive lymphoma and redefining the clinical first-line treatment of lymphoma. (Bio Valley)