Thusday, seagen share that its phase III trial of ADCETRIS (brentuximab vedotin) demonstrated significant improvements in overall survival (OS) for patients diagnosed with advanced classical Hodgkin’s lymphoma (cHL).
Data from Phase III ECHELON-1, a randomized, open-label clinical study in 1,334 adult participants with stage III or IV cHL, showed consistent improvement in OS over each of six 28-day cycles finished. OS is the primary secondary endpoint of the trial, while its primary endpoint is modified progression-free survival.
LCH is a type of blood cancer that begins when lymphocytes grow out of control. According to American Cancer Societyapproximately 8,450 new cases of LH will appear in 2022 and it is estimated that some 920 will die from the disease in the United States alone.
Participants received ADCETRIS along with chemotherapy for the study and were followed up after about six years.
Seagen researchers found that those who received ADCETRIS plus doxorubicin, vinblastine and dacarbazine (A+AVD) saw their risk of death drop by 41% compared to the group of patients receiving ADCETRIS. doxorubicin, bleomycin, vinblastine and dacarbazine (ABVD). Patients were randomly assigned to each group and received the drugs intravenously on day 1 and day 15 of a 28-day cycle. The entire study comprised six cycles.
“These groundbreaking results are important for patients with advanced classical Hodgkin’s lymphoma given that improved overall survival has rarely been demonstrated in first-line treatment for this disease,” commented Dr. Roger Dansey, MD. -head of Seagen, in a press release.
ADCETRIS is an antibody-drug conjugate approved for use in certain types of relapsed or refractory Hodgkin lymphoma, as well as previously untreated stage III/IV cHL and peripheral T-cell lymphoma (PTCL). It is also approved for previously untreated systemic anaplastic large cell lymphoma (sALCL), other CD30-expressing PTCLs, including angioimmunoblastic T-cell lymphoma, and sALCL after failure of at least one regimen prior multi-agent chemotherapy, among others.
The drug is developed by Seagen and Takeda, which fund joint development costs on a 50/50 basis worldwide, with the exception of Japan where only Takeda is responsible for development expenditures. ADCETRIS has marketing authorization in more than 75 countries and is currently undergoing at least 70 clinical trials in various indications in lymphoma and other diseases.
Details of the latest results will be shared at the company’s next medical meeting.