Takeda, Seattle Genetics Report Positive Results From Phase 3 ECHELON-1 Trial

(RTTNews) - Takeda Pharmaceutical Company Limited (TKPYY.PK) and Seattle Genetics Inc. (SGEN) announced that the Phase 3 ECHELON-1 clinical trial met its primary endpoint of a statistically significant improvement in modified progression-free survival or PFS versus the control arm. ECHELON-1 is a randomized, multicenter trial evaluating ADCETRIS (brentuximab vedotin) as part of a frontline combination chemotherapy regimen in 1,334 patients with previously untreated advanced classical Hodgkin lymphoma.

ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma. ADCETRIS is currently not approved as a frontline therapy for Hodgkin lymphoma.

Patients in ECHELON-1 were randomized to receive either a combination of ADCETRIS+AVD (Adriamycin, vinblastine, dacarbazine) or ABVD (Adriamycin, bleomycin, vinblastine, dacarbazine), a recognized standard of care for frontline Hodgkin lymphoma. The results of the ECHELON-1 trial demonstrated that combination treatment with ADCETRIS resulted in a statistically significant improvement in modified PFS versus the control arm as assessed by an Independent Review Facility (hazard ratio=0.770; p-value=0.035).

The two-year modified PFS rate for patients in the ADCETRIS arm was 82.1 percent compared to 77.2 percent in the control arm. Interim analysis of overall survival (OS), the key secondary endpoint, also trended in favor of the ADCETRIS+AVD arm

Takeda and Seattle Genetics plan to submit these results to regulatory authorities for approval in their respective territories.