Seattle Genetics Highlights ADCETRIS® (Brentuximab Vedotin) Frontline HL and MTCL Clinical Development Programs and …

CHICAGO--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today highlighted ongoing clinical development programs for ADCETRIS (brentuximab vedotin) in frontline Hodgkin lymphoma (HL) and mature T-cell lymphoma (MTCL) and progress with collaborator antibody-drug conjugate (ADC) programs that were presented at the 49th Annual Meeting of the American Society of Clinical Oncology being held May 31 June 4, 2013, in Chicago, IL. The phase 3 clinical trials, called ECHELON-1 and ECHELON-2, are evaluating ADCETRIS for the frontline treatment of HL and MTCL, including patients with systemic anaplastic large cell lymphoma (sALCL) and other types of peripheral T-cell lymphoma. ADCETRIS is an ADC directed to CD30, a defining marker of HL and sALCL, which was granted accelerated approval by the FDA in August 2011 for relapsed HL and relapsed sALCL. In addition, encouraging phase 1 data were presented from two ADC clinical programs being developed by Genentech, a member of the Roche Group (RO.SW) (SWX:ROG)(RHHBY), using Seattle Genetics technology.

ADCs represent an innovative and growing field in the fight against cancer, which is evident by the interest in this therapeutic approach at the ASCO annual meeting, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. As the first ADC to be approved by the FDA in this new class, we are focused on broadening the evaluation of ADCETRIS in earlier lines of therapy with our ongoing ECHELON-1 and ECHELON-2 global phase 3 trials, which are designed to redefine the standard of care for frontline treatment of HL and MTCL. While we advance our internal programs, our collaborators are making important progress utilizing our ADC technology. Notably, Genentech is presenting encouraging phase 1 data for two ADC candidates in solid tumor settings.

Seattle Genetics is the leader in developing ADCs, a technology designed to harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. Of the approximately 30 ADC candidates currently in development, more than half utilize Seattle Genetics proprietary ADC technology.

Phase III Trial of Brentuximab Vedotin Plus Doxorubicin, Vinblastine, and Dacarbazine (A+AVD) Versus Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) as Front-line Treatment for Advanced Classical Hodgkin Lymphoma (HL) (Abstract #TPS8612)

Recent phase 1 data presented at the 2012 American Society of Hematology (ASH) Annual Meeting demonstrated that A+AVD, which removes bleomycin from the standard frontline ABVD regimen, was associated with a manageable safety profile and a complete remission (CR) rate of 96 percent in the treatment of newly diagnosed HL patients. A global phase 3 study, called ECHELON-1, is an ongoing open-label, randomized, multi-center trial designed to investigate A+AVD versus ABVD as frontline therapy in patients with advanced classical HL. The primary endpoint is modified progression free survival (mPFS) per independent review facility assessment using the Revised Response Criteria for malignant lymphoma (Cheson, 2007). Secondary endpoints include overall survival (OS), CR rate and safety. The trial is being conducted in North America, Europe, Latin America and Asia. The study will enroll approximately 1,040 eligible patients (approximately 520 patients per treatment arm) who have histologically-confirmed diagnosis of Stage III or IV classical HL and who have not been previously treated with systemic chemotherapy or radiotherapy.

Phase III Trial of Brentuximab Vedotin and CHP Versus CHOP in the Frontline Treatment of Patients with CD30+ Mature T-Cell Lymphomas (MTCL) (Abstract #TPS8611)

Recent phase 1 data presented at the 2012 ASH Annual Meeting demonstrated that ADCETRIS in combination with cyclophosphamide, doxorubicin and prednisone (A+CHP) in the frontline treatment of MTCL was associated with a manageable safety profile and 100 percent objective response rate, including 88 percent CRs. A global phase 3 study, called ECHELON-2, is an ongoing randomized, double-blind, placebo-controlled, multi-center trial designed to investigate A+CHP versus cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) as frontline therapy in patients with CD30-expressing MTCL. Approximately 300 patients (approximately 150 patients per treatment arm) will be randomized to receive A+CHP or CHOP for six to eight cycles every three weeks. The primary endpoint is progression-free survival (PFS) per independent review facility assessment using the Revised Response Criteria for malignant lymphoma. Secondary endpoints include OS, CR rate and safety. The trial is being conducted in North America, Europe and Asia.

ADCETRIS is currently not approved for frontline treatment of HL and MTCL. For more information about ECHELON-1 and ECHELON-2, visit http://www.clinicaltrials.gov.

A Phase I Study of the Safety and Pharmacokinetics of DNIB0600A, an Anti-Napi2b-vc-MMAE Drug Conjugate, in Patients with Non-Small Cell Lung Cancer (NSCLC) and Platinum-Resistant Ovarian Cancer (OC) (Abstract #2507)

Read the original here:
Seattle Genetics Highlights ADCETRIS® (Brentuximab Vedotin) Frontline HL and MTCL Clinical Development Programs and ...