After halting a Phase II B-cell lymphoma study, Seattle Genetics is left with four early-stage trials in NHL and myeloma.

Genentech has dropped its collaboration with Seattle Genetics to develop the latter’s CD40-targeting mAb dacetuzumab. Termination of the dacetuzumab partnership does not affect the companies’ ongoing antibody-drug conjugate (ADC) deal.

Seattle Genetics says that Genentech’s decision resulted from its ongoing portfolio review process. As recently as October 5, the companies stopped a Phase II trial with dacetuzumab in relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after an interim analysis showed that it was not likely to meet its primary endpoint of superior complete response rate.

Under the terms of the companies’ dacetuzumab agreement, the effective date of the termination is taken as 180 days from notification, or June 8 2010, at which time all rights to the drug will be returned to Seattle Genetics. Genentech will remain responsible for the development costs associated with completing all ongoing clinical trials for the drug as of the effective termination date. Dacetuzumab is currently undergoing four Phase Ib trials in combination with standard treatment for relapsed or refractory non-Hodgkin lymphoma and multiple myeloma.

“We will evaluate available data as we consider possible next steps for the dacetuzumab program,” comments Clay B. Siegall, Ph.D., Seattle’s president and CEO. “We remain focused on advancing our lead product candidate, brentuximab vedotin, which we are positioning for a potential NDA in 2011, as well as multiple other clinical and preclinical programs in our portfolio.”

Brentuximab vedotin is in Phase III development as a treatment for relapsed or refractory Hodgkin lymphoma. It is also being tested in Phase I and II as a treatment for relapsed or refractory systemic anaplastic large cell lymphoma (ALCL), relapsed Hodgkin lymphoma, systemic ALCL, and other CD30-positive hematologic malignancies.

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