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Seattle Gene (Seagen) recently announced the data of the Phase 3 ECHELON-1 study (NCT0112490).
) in patients with advanced classical Hodgkin lymphoma (cHL) treated with chemotherapy combined with a statistically significant improvement in overall survival (OS) (p=0.
009)
.
ECHELON-1 is a randomized, open-label, international phase 3 study in adults with newly diagnosed advanced (stage III or IV) cHL to compare Adcetris combined with chemotherapy AVD (doxorubicin + vincristine) Efficacy and safety of ABVD (doxorubicin + bleomycin + vincristine + dacarbazine) relative to the currently accepted standard-of-care regimen ABVD (doxorubicin + bleomycin + vincristine + dacarbazine)
.
The study enrolled 1334 adult patients with histologically confirmed stage III or IV cHL who had not received prior systemic chemotherapy or radiation therapy
At a median follow-up of about 6 years, the A+AVD group had a 41% lower risk of death compared with the ABVD group (HR=0.
59 [95%CI: 0.
396-0.
879])
.
The safety profile of Adcetris was consistent with previous studies, and no new safety signals were observed
Detailed data from the study will be presented at an upcoming medical meeting
.
These groundbreaking results are important for patients with advanced cHL
Adcetris is approved for certain types of relapsed or refractory Hodgkin lymphoma (HL), including previously untreated advanced (stage III/IV) cHL and previously untreated peripheral T-cell lymphoma tumor (PTCL)
.
Adcetris is an antibody-drug conjugate (ADC) composed of a monoclonal antibody targeting the CD30 protein and a microtubule disruptor (monomethyl auristatin E, MMAE) coupled through a protease-sensitive cross-linker The coupling technology is a proprietary technology of Seattle Genetics
.
CD30 protein is a clear marker of classical Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL), and Auristatin E can block cell division by inhibiting tubulin polymerization
Adcetris, a standard-of-care drug for the treatment of relapsed or refractory (r/r) cHL, was developed by Seattle Genetics, and Takeda entered into a licensing agreement in 2009 to obtain commercial commercialization of the drug in countries other than the United States and Canada.
rights
.
Up to now, Adcetris has been approved in more than 70 countries around the world, with as many as 6 indications, and the indications in different countries are different
In the United States, Adcetris has been approved for 6 adult indications, including: (1) Combined with doxorubicin + vincristine + dacarbazine (AVD), first-line treatment of previously untreated (naïve) stage III or IV stage classical Hodgkin lymphoma (cHL); (2) cHL with an elevated risk of recurrence or progression after consolidation with autologous hematopoietic stem cell transplantation (ASCT); (3) failed autologous HSCT, or is not suitable for autologous HSCT and cHL who have failed at least 2 multi-drug chemotherapy regimens; (4) combined with cyclophosphamide + doxorubicin + prednisone, first-line treatment of systemic anaplastic large cell lymphoma ( sALCL) or other CD30-expressing peripheral T-cell lymphoma (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified; (5) sALCL that has previously failed at least one multi-agent chemotherapy regimen (6) Primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have previously received systemic therapy
In China, the National Medical Products Administration (NMPA) officially approved Adcetris (English trade name: Adcetris, generic name: brentuximab vedotin, Velbutuximab for injection) in May 2020 for the treatment of relapsed or refractory Adult patients with systemic anaplastic large cell lymphoma (sALCL) or CD30-positive Hodgkin lymphoma (HL)
Currently, Takeda and Seattle Genetics are actively advancing a large Phase III clinical development program to develop Adcetris as a primary care drug for CD30-positive lymphoma and redefine first-line clinical treatment of lymphoma
