CAMBRIDGE, MASS. & OSAKA, JAPAN & BOTHELL, WASH.-- May 30, 2022 -- Takeda Pharmaceutical Company Limited (TSE:4502) and Seagen Inc., (NASDAQ:SGEN) today announced that overall survival (OS) data from the Phase 3 ECHELON-1 clinical trial of an ADCETRIS (brentuximab vedotin) plus chemotherapy combination will be presented in an oral session at the 59th American Society of Clinical Oncology (ASCO) Annual Meeting on Friday, June 3, 2022, 1:00-4:00 PM CT, and at the 27th European Hematology Association (EHA) Annual Meeting on Friday, June 10, 2022, 11:30 - 12:45 CEST.

“The longer-term follow-up data from the ECHELON-1 trial have significant clinical importance, as this trial represents one of only two frontline randomized studies in advanced stage Hodgkin lymphoma that shows an overall survival advantage for the experimental arm,” said Stephen Ansell, M.D., Ph.D., Mayo Clinic, and ECHELON-1 study investigator. “These results clearly show that the addition of brentuximab vedotin to chemotherapy improves the long-term outcome of patients and the combination should be considered a standard of care.”

Data from the ECHELON-1 trial demonstrated a statistically significant improvement in OS in adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma treated with ADCETRIS plus doxorubicin, vinblastine and dacarbazine (A+AVD) vs. doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). With approximately six years median follow up (73 months), patients receiving A+AVD had a 41 percent reduction in the risk of death (hazard ratio [HR] 0.59; 95% confidence interval [CI]: 0.396 to 0.879), with an estimated OS rate (95% CI) of 93.9% (91.6, 95.5) at 6 years. The safety profile of ADCETRIS was consistent with previous studies, and no new safety signals were observed. Please see Important Safety Information, including a SPECIAL/BOXED WARNING for progressive multifocal leukoencephalopathy (PML), for ADCETRIS below.

“Patients with advanced-stage Hodgkin lymphoma have not benefitted from an improvement in overall survival outcomes for far too long,” said Chris Arendt, Ph.D., Head of Oncology Cell Therapy and Therapeutic Area Unit, Research and Development, at Takeda. “We are extremely proud of the results of the ECHELON-1 trial, as these findings represent a transformative improvement in care that can profoundly impact the lives of patients with advanced-stage disease. We look forward to sharing the data with regulators around the world.”

“These data unequivocally demonstrate the ability of the ADCETRIS combination regimen to improve upon a current standard of care, ABVD, for people with Hodgkin lymphoma by delivering an unsurpassed overall survival benefit,” said Roger Dansey, M.D., Interim CEO and Chief Medical Officer, Seagen. “We continue to evaluate the potential of ADCETRIS in different patient populations and in combination with other approved and investigational medicines.”

ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma in combination with AVD in the United States and for the treatment of adult patients with previously untreated CD30-positive Stage IV Hodgkin lymphoma in combination with AVD in Europe.

First-line brentuximab vedotin plus chemotherapy to improve overall survival in patients with stage III/IV classical Hodgkin lymphoma: An updated analysis of ECHELON-1. (Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia on Friday, June 3, 2022, 1:00 PM-4:00 PM CT at McCormick Place, Hall A8)

Key findings, which will be presented by Dr. Ansell, include:

· The trial achieved its key secondary endpoint with the combination of A+AVD, resulting in a statistically significant improvement in OS versus the control arm of ABVD as assessed by an Independent Review Facility (IRF) (HR 0.59; p-value=0.009). This corresponds to a 41 percent reduction in the risk of death.
。At a median follow up of 73 months, 39 and 64 OS events occurred in the A+AVD and ABVD arms, respectively.
。Estimated six-year OS rates (95% CI) were 93.9% (91.6, 95.5) with A+AVD vs. 89.4% (86.6, 91.7) with ABVD.
。Subgroup analyses supported a consistent benefit for A+AVD vs. ABVD.
· The six-year PFS estimate (95% CI) was 82.3% (79.1, 85.0) with A+AVD vs. 74.5% (70.8, 77.7) with ABVD.
· A+AVD resulted in a manageable safety profile consistent with prior reports.
。Treatment-emergent peripheral neuropathy continued to resolve or improve in both arms, with 86% (379/443) and 87% (249/286) of patients in the A+AVD and ABVD arms, respectively, either completely resolving (72% vs. 79%) or improving (14% vs. 8%) by last follow up.
。Fewer patients reported second malignancies in the A+AVD vs. ABVD arm (23 vs. 32).
。No new safety signals were identified.