Takeda, Seattle Genetics' Adcetris hits main goal of late-stage study as front-line treatment for Ho

Takeda and Seattle Genetics said Monday that a Phase III study investigating Adcetris (brentuximab vedotin) as part of a front-line combination chemotherapy regimen for patients with previously untreated advanced classical Hodgkin lymphoma met its primary endpoint. The companies indicated that they plan to submit the results to regulatory authorities for approval in their respective territories.

In the ECHELON-1 study, 1334 patients who had a histologically confirmed diagnosis of Stage III or IV classical Hodgkin lymphoma and no history of treatment with systemic chemotherapy or radiotherapy were randomised to receive Adcetris in combination with doxorubicin, vinblastine and dacarbazine or doxorubicin, bleomycin, vinblastine and dacarbazine. Takeda and Seattle Genetics noted that the latter regimen is a recognised standard of care for front-line Hodgkin lymphoma.

Results showed that the Adcetris regimen significantly improved two-year modified progression-free survival versus the control arm, with rates of 82.1 percent and 77.2 percent, respectively. The companies added that an interim analysis of overall survival, the key secondary goal of the study, also trended in favour of the Adcetris regimen. Other secondary endpoints of the trial included complete remission and safety.

Clay Siegall, CEO of Seattle Genetics, commented "notably, this is the first clinical trial in front-line advanced Hodgkin lymphoma to show superior efficacy of a regimen that eliminates bleomycin." The companies added that data from the trial will be presented at the American Society of Hematology (ASH) annual meeting in December.

Despite the results, shares in Seattle Genetics fell as much as 11 percent on the news. SunTrust Bank analyst Yatin Suneja said that the relatively modest improvement of about 5 percent offered by Adcetris could generate cost concerns among payers. However, Suneja suggested that the benefit of removing bleomycin from the treatment regimen could be substantial, particularly for younger patients.

Adcetris, which is an antibody-drug conjugate directed to CD30, is approved in the US for the treatment of patients with classical Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplantation (HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not autologous HSCT candidates, as well as for the treatment of classical Hodgkin lymphoma patients at high risk of relapse or progression as post-autologous HSCT consolidation. The therapy has also been granted FDA accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. North American sales of the drug, which is cleared in 67 countries for relapsed or refractory Hodgkin lymphoma and sALCL, reached about $266 million last year.