Seattle Genetics, Inc. ( SGEN ) recently commenced a phase I/II study to evaluate Adcetris in combination with Teva Pharmaceutical Industries Ltd. 's ( TEVA ) Treanda (bendamustine) for Hodgkin lymphoma (HL) patients after first relapse.
The single-arm, open-label study is divided into two cohorts. The phase I cohort's primary endpoint is to find the recommended dosing level of Treanda in combination with Adcetris and evaluate the safety and tolerability of this combination.
The complete remission rate will be assessed as the primary endpoint of the phase II cohort. Secondary endpoints include best response, duration of response and progression-free survival.
After receiving Adcetris plus Treanda patients will have an option to suspend the therapy and undergo an autologous stem cell transplant (ASCT) following which treatment with single-agent Adcetris will be resumed.
Seattle Genetics also announced that Adcetris data on first line salvage therapy in relapsed/refractory HL was presented recently. In this study, 85.7% of the patients showed an objective response rate.
In May 2013, the US Food and Drug Administration (FDA) accepted a supplemental biologics license application (sBLA) for Adcetris for retreatment and extended duration of medication with the drug beyond 16 cycles in relapsed HL and systemic anaplastic large cell lymphoma (sALCL).
We note that Adcetris was approved by the FDA in Aug 2011 for the treatment of patients with HL after failure of ASCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not suitable for ASCT. Adcetris was also approved for sALCL in treatment-experienced patients.
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