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ARTICLE | Clinical News

Adcetris meets modified PFS endpoint in Phase III for first-line classical Hodgkin's lymphoma

July 7, 2017 8:07 PM UTC

Seattle Genetics Inc. (NASDAQ:SGEN) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) reported data from the Phase III ECHELON-1 trial in 1,334 patients with stage III or IV classical Hodgkin's lymphoma not previously treated with systemic chemotherapy or radiotherapy showing that Adcetris brentuximab vedotin (SGN-35) plus adriamycin, vinblastine and dacarbazine (AVD) chemotherapy as first-line treatment met the primary endpoint of improving 2-year modified progression-free survival (PFS) rate vs. adriamycin, bleomycin, vinblastine and dacarbazine (ABVD) chemotherapy (82.1% vs. 77.2%, HR=0.77, p=0.035). Modified PFS was defined as time to progression, death or use of additional therapy in patients not achieving a complete response following completion of first-line treatment. The partners said the modified PFS endpoint eliminates the "confounding impact" of salvage and consolidation chemotherapies and radiotherapy. Additionally, an interim analysis of overall survival (OS), a secondary endpoint, "trended in favor" of Adcetris plus AVD chemotherapy. Patients in the ABVD arm had an increased rate and severity of pulmonary toxicity, which the company said is associated with bleomycin.

The partners have an SPA from FDA for the open-label, international trial and have received scientific advice from EMA. Secondary endpoints include complete remission and safety. Data will be submitted for presentation at the American Society of Hematology meeting in Atlanta in December. The partners also plan to submit the data for regulatory approval in their respective territories, but declined to disclose details...