Takeda and Seattle Phase III Adcetris trial meets endpoint

Takeda Pharmaceutical (TYO: 4502) and Seattle Genetics (Nasdaq: SGEN) have said that the Phase III ALCANZA clinical trial evaluating Adcetris (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL) met its primary endpoint, demonstrating a highly statistically-significant improvement in the rate of objective response lasting at least four months (ORR4).

US biotech firm Seattle Genetics saw its shares rise 2.37% to $49.20 by late morning trading following the announcement, while Takeda gained 4.62% to 4,800 yen.

This randomized trial, which received a Special Protocol Assessment (SPA) from the US Food and Drug Administration and scientific advice from the European Medicines Agency, compared the use of single-agent Adcetris to a control arm of investigator’s choice of standard therapies, methotrexate or bexarotene, in 131 patients with CD30-expressing CTCL who received prior systemic or radiation therapy. Adcetris is currently not approved for the treatment of CTCL, but has been cleared for marketing in more than 60 countries for other indications.