Takeda and Seattle Genetics Highlight Post-Hoc Analysis Examining Progression-free Survival with ADC

 　　Analysis showed more than 60 percent of patients achieved longer progression-free survival following treatment with ADCETRIS compared to prior therapy

　　LUGANO, Switzerland -- (BUSINESS WIRE) --

　　Takeda Pharmaceutical Company Limited (TSE:4502) and Seattle Genetics, Inc. (NASDAQ: SGEN) today announced data from a post-hoc analysis examining progression-free survival (PFS) following treatment with ADCETRIS® (brentuximab vedotin) versus last prior therapy in patients diagnosed with relapsed or refractory Hodgkin lymphoma (HL) post-autologous stem cell transplant (ASCT) or relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). The data were highlighted during a presentation at the 12thInternational Conference on Malignant Lymphoma (ICML) being held June 19–22, 2013 in Lugano, Switzerland.

　　ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and sALCL.

　　The post-hoc analysis compared investigator assessed PFS following ADCETRIS single-agent treatment to the last prior systemic therapy in patients taking part in two pivotal Phase 2 studies. The post-hoc analysis was conducted in patients with relapsed or refractory HL post-ASCT or relapsed or refractory sALCL in the intent-to-treat (ITT) population. It also included prior systemic treatment histories and post-ADCETRIS stem cell transplant experience for each patient in the ITT populations.

　　“These encouraging data suggest that ADCETRIS may delay disease progression compared to prior therapies used in this heavily pretreated patient population,” said John Radford, M.D., Professor of Medical Oncology, University of Manchester, Manchester, UK. “ADCETRIS is a CD30-targeted treatment option for patients with relapsed or refractory HL or relapsed or refractory sALCL that has shown a high overall response rate, including durable complete responses in both of its approved indications.”

　　Progression-free survival analyses of two pivotal phase 2 studies of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma or systemic anaplastic large-cell lymphoma (Poster #303)

　　The analysis, presented by Dr. Radford, included:

　　Relapsed or Refractory HL post-ASCT

　　102 patients (median age 31 years) diagnosed with relapsed or refractory HL post-ASCT received a median of 3.5 (range, 1–13) prior chemotherapy regimens, not including ASCT, prior to enrollment in the study

　　91 percent of patients received doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD) as front-line therapy

　　Approximately one-half of patients received ifosfamide, carboplatin, etoposide (ICE) as second-line therapy

　　There was no discernible pattern in terms of treatment regimens after second-line therapy

　　As expected this was a very heavily pretreated population prior to study entry

　　62 percent of patients achieved a longer PFS with ADCETRIS than with their last prior therapy at a median follow-up of 27 months

　　Median PFS was 9.3 months (range, 1.2–36.4) with ADCETRIS versus 6.1 months (range, 1.0–110.2) with last prior therapy

　　63 percent of patients who relapsed within six months of their most recent ASCT and 65 percent of patients who relapsed within twelve months of their most recent ASCT achieved a longer PFS with ADCETRIS than with their last prior systemic therapy

　　20 patients underwent a stem cell transplant (STC) after receiving ADCETRIS, including:

　　ASCT (1 patient), allogeneic SCT (18 patients), ASCT followed by allogeneic SCT (1 patient)

　　7 patients received a transplant after treatment with ADCETRIS alone

　　Relapsed or Refractory sALCL

　　58 patients (median age 52 years) diagnosed with relapsed or refractory sALCL received a median of 2 (range, 1–6) prior chemotherapy regimens, not including ASCT, prior to their enrollment into the study

　　Cyclophosphamide, hydroxy doxorubicin, Oncovin®, prednisone (CHOP) was the most commonly used regimen (72 percent) in patients, either as first-line induction therapy or as maintenance therapy

　　Most agents were given as part of a combination regimen

　　67 percent of patients achieved a longer PFS with ADCETRIS than with their last prior therapy at a median follow-up 22 months

　　Median PFS was 19.6 months (range, 0.8–29.0) with ADCETRIS versus 5.9 months (range, 0.3–111.9) with the last prior therapy

　　20 patients underwent a SCT after receiving ADCETRIS, including:

　　ASCT (9 patients) and allogeneic SCT (11 patients)

　　17 patients received a transplant after treatment with ADCETRIS alone

　　Details of the poster presentation are as follows:

　　Poster available on June 19, 2013 12:00 PM CET

　　Poster #303

　　First author: John Radford, M.D., Professor of Medical Oncology, University of Manchester, Manchester, UK

　　Additional oral and poster presentations featured at ICML about ADCETRIS include:

　　Objective responses in relapsed B-cell lymphomas with single-agent brentuximab vedotin

　　Poster session on Thursday, June 20, 2013 from 8:30 AM - 6:30 PM CET

　　Abstract #304

　　First author: Eric D. Jacobsen, M.D., Dana-Farber Cancer Institute, Boston, MA

　　ECHELON-2: phase 3 trial of brentuximab vedotin and CHP versus CHOP in the frontline treatment of patients (pts) with CD30+ mature T-cell lymphomas (MTCL)

　　Oral session on Friday, June 21, 2013 at 5:25 PM CET

　　Abstract #138

　　First author: Owen A. O'Connor, M.D., Ph.D., Professor, and Director, Division of Hematology and Medical Oncology at NYU Cancer Institute, New York, NY

　　Oral session on Saturday, June 22, 2013 at 8:40 AM CET

　　Abstract #140

　　First author: Robert Chen, M.D., City of Hope National Medical Center. Duarte, CA

　　Oral session on Saturday, June 22, 2013 at 8:50 AM CET

　　Abstract #141

　　First author: Alison J. Moskowitz, M.D., Memorial Sloan-Kettering Cancer Center, New York, NY

　　Oral session on Saturday, June 22, 2013 at 10:00 AM CET

　　Abstract #152

　　First author: Yasuhiro Oki, M.D., Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX

　　Two-year follow up of patients with relapsed/refractory Hodgkin treated with brentuximab vedotin prior to reduced intensity allogeneic hematopoietic cell transplantation

　　PET-adapted sequential therapy with brentuximab vedotin and augmented-ICE induces FDG-PET normalization in 92% of patients with relapsed and refractory Hodgkin lymphoma

　　Safety and efficacy of brentuximab vedotin for treatment of relapsed mature T-/NK-cell lymphomas

　　About ADCETRIS® (brentuximab vedotin)

　　ADCETRIS® (brentuximab vedotin) is the first and only targeted CD30 antibody-drug conjugate (ADC) being evaluated in a variety of CD30-expressing malignancies including Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). The ADC utilizes Seattle Genetics’ proprietary technology, which employs a linker system designed to be stable in the bloodstream but to release monomethyl auristatin E (MMAE) upon internalization into CD30-expressing tumor cells.

　　ADCETRIS wa