Seattle Genetics Announces Initiation of Phase 2 Trial of ADCETRIS® (Brentuximab Vedotin) in Combination with Current …

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today announced the initiation of a phase 2 clinical trial evaluating ADCETRIS (brentuximab vedotin) in combination with RCHOP (A+RCHOP), the current standard frontline therapy, for newly diagnosed patients with diffuse large B-cell lymphoma (DLBCL). The study is intended to evaluate the complete remission rate and safety of the A+RCHOP regimen. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS is currently not approved for the treatment of DLBCL.

The encouraging data we have observed in our phase 2 trial of ADCETRIS in relapsed non-Hodgkin lymphoma, including DLBCL patients, support evaluation in earlier lines of therapy for patients with this aggressive lymphoma type, said Clay B. Siegall., Ph.D., President and Chief Executive Officer at Seattle Genetics. This trial will provide us with data on the tolerability of the combination, as well as the antitumor activity achieved by adding ADCETRIS to the current standard frontline regimen. In addition, based on interim findings from our trial in the relapsed setting in which objective responses were observed among patients with low or undetectable levels of CD30 by conventional screening methods, we will enroll high-risk DLBCL patients to this frontline trial without prescreening for CD30 expression.

In this phase 2, open-label clinical trial, approximately 50 frontline high-risk DLBCL patients will receive ADCETRIS in combination with the standard of care consisting of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (A+RCHOP). Patients will be randomized to receive standard dose RCHOP with either 1.2 milligrams per kilogram (mg/kg) or 1.8 mg/kg of ADCETRIS. The trial will enroll patients regardless of CD30 expression level by immunohistochemistry (IHC) to further explore previously reported interim data from an ongoing phase 2 trial for relapsed B-cell lymphomas, including DLBCL, demonstrating objective responses in patients with varying levels of CD30. The primary endpoints are to assess the complete remission rate and safety profile of the combination. Secondary endpoints include objective response rate, progression-free survival and overall survival.

At the International Conference on Malignant Lymphoma in June 2013, data were presented from an ongoing phase 2 trial for relapsed B-cell lymphomas that included 44 relapsed patients who received single-agent ADCETRIS, including 25 with DLBCL. Among DLBCL patients, the objective response rate was 44 percent (11 of 25), including 20 percent complete remissions and 24 percent partial remissions. Eighty-one percent of patients achieved tumor reduction. Among 44 B-cell lymphoma patients enrolled, the most common treatment-emergent adverse events were neutropenia (43 percent), fatigue (36 percent), nausea (34 percent) and diarrhea (32 percent). The most common Grade 3 or 4 adverse events were neutropenia (25 percent Grade 3; 11 percent Grade 4) and anemia (9 percent Grade 3).

More information about the ongoing phase 2 frontline or relapsed DLBCL trials, including enrolling centers, is available by visiting http://www.clinicaltrials.gov.

About Diffuse Large B-Cell Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Non-Hodgkin lymphoma (NHL) represents a diverse group of cancers that develop in the lymphatic system and are characterized by uncontrolled growth and accumulation of abnormal lymphocytes. Lymphocytes are a type of white blood cells that are responsible for defending the body against infection. The most common forms of NHL are follicular (slow growth) and diffuse large B-cell lymphoma (a faster growing sub-type).

About ADCETRIS

ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

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Seattle Genetics Announces Initiation of Phase 2 Trial of ADCETRIS® (Brentuximab Vedotin) in Combination with Current ...