Brentuximab vedotin on track for BLA filing with FDA during first half of 2011.

Seattle Genetics and Millennium Pharmaceuticals confirmed plans to submit a BLA for the antibody-drug conjugate (ADC) candidate brentuximab vedotin (SGN-35) to FDA during the first half of 2011, on the back of positive topline data from a pivotal trial in patients with relapsed or refractory Hodgkin lymphoma (HL). Data from a Phase II trial in patients with relapsed or refractory systemic anaplastic large cell lymphoma are separately expected within the next few weeks, the firms add.

The pivotal HL study, carried out under an SPA with FDA, included 102 patients who had received autologous stem cell transplants. The reported data showed that monotherapy with brentuximab vedotin led to 75% of participants achieving an objective response according to the international revised response criteria for malignant lymphoma. The median duration of response was over six months. Full data from the study are due for presentation at a forthcoming scientific meeting, the firms note.

Brentuximab vedotin comprises an anti-CD30 mAb attached to the synthetic drug monomethyl auristatin E (MMAE) using Seattle’s enzyme-cleavable linker technology, which is designed to be stable in the bloodstream and only release MMAE on internalization into CD30-expressing tumor cells. The ADC is also undergoing Phase III evaluation in patients at high risk of residual HL following autologous stem cell transplantation. A Phase II retreatment trial in relapsed patients who previously responded to brentuximab vedotin is in addition ongoing, along with a Phase I combination study evaluating brentuximab vedotin as front-line HL therapy.

Seattle and Millennium are developing brentuximab vedotin under a collaboration agreement that gives Millennium’s parent company Takeda rights to the drug worldwide, except for the U.S. and Canada, which are retained by Seattle. The firms are funding the development costs on a 50:50 basis worldwide except for Japan, where Takeda has sole responsibility for funding development.

Earlier this month Seattle teamed up with Genmab for a research collaboration that aims to combine the ADC technology with Genmab’s HuMax-TF antibody targeting the tissue factor antigen. Under terms of the deal, Seattle has the right to exercise a co-development option for any resulting ADC products at the end of Phase I clinical development.

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