Takeda Pharmaceutical Company Limited Announces Executive Changes
Dec 18 14
Takeda Pharmaceutical Company Limited announced that Andrew "Andy" Plump, M.D., Ph.D., has been approved by the company's Board of Directors as Corporate Officer and Chief Medical and Scientific Officer (CMSO) Designate. Dr. Plump will join Takeda in February 1, 2015. In his new position, Dr. Plump will lead Takeda's global R&D operations and will report directly to Christophe Weber, President and Chief Operating Officer of Takeda. Dr. Plump's appointment follows the planned retirement of Tadataka "Tachi" Yamada, M.D., Takeda's current Chief Medical and Scientific Officer. Dr. Yamada will remain CMSO and assist in the transition of leadership. He will retire as CMSO and as a Member of Takeda's Board of Directors in June 2015. Most recently at Sanofi, Dr. Plump served as Senior Vice President, Research & Translational Medicine, Deputy to the President R&D, based in Paris. Dr. Yamada will facilitate the transition of leadership. Dr. Yamada will remain a Member of Takeda's Board of Directors until June 2015.
Seattle Genetics Inc. and Takeda Pharmaceutical Company Limited Announces Data from Phase III Lymphoma Trial
Dec 17 14
Seattle Genetics Inc. and Takeda Pharmaceutical Company Limited have announced data from Phase III AETHERA trial, which demonstrates that Hodgkin lymphoma, or HL, patients at risk of relapse following an autologous stem cell transplant, or ASCT, who received ADCETRIS, or brentuximab vedotin, as consolidation therapy immediately after ASCT had significant improvement in progression-free survival, or PFS, compared to patients who received placebo. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL. ADCETRIS has been approved in more than 45 countries for the treatment of relapsed or refractory HL and systemic anaplastic large cell lymphoma (sALCL). ADCETRIS is currently not approved in the AETHERA treatment setting. The Phase III AETHERA trial was designed to evaluate the potential of single agent ADCETRIS to extend PFS post-ASCT in patients with HL who have at least one risk factor for progression. In addition to the primary endpoint of PFS, secondary endpoints included overall survival (OS), safety and tolerability. Eligible patients must have had a history of refractory HL, have relapsed within one year from receiving frontline chemotherapy and/or have had disease outside of the lymph nodes at the time of pre-ASCT relapse. These factors are consistently reported to be associated with poor prognosis after transplant. Patients received ADCETRIS or placebo every three weeks for up to approximately one year. This international multi-center trial was conducted at 78 sites in the US, Eastern and Western Europe and Russia. A total of 329 HL patients at risk of relapse were enrolled, including 165 on the ADCETRIS arm and 164 on the placebo arm. Patients received a median of 15 cycles of treatment on both arms, with an average of 12 cycles on the ADCETRIS arm and 11 cycles on the placebo arm. The trial achieved its primary endpoint and demonstrated a significant increase in PFS per independent review facility (IRF), with a hazard ratio of 0.57 and a p-value of 0.001. Median PFS per IRF was 43 months for patients who received ADCETRIS versus 24 months for patients who received placebo. The two-year PFS rate per IRF was 63% in the ADCETRIS arm compared to 51% in the placebo arm. Per investigator, the hazard ratio was 0.50. The two-year PFS rate per investigator was 65% in the ADCETRIS arm compared to 45% in the placebo arm. The median PFS per investigator has not yet been reached for patients who received ADCETRIS versus 16 months for patients who received placebo. Very few progression events have been observed beyond two years. The PFS benefit was consistent across all pre-specified subgroups, including primary refractory patients, patients who relapsed within twelve months of frontline therapy and patients who relapsed after twelve months with extranodal disease. Patients in both arms of the study who experienced disease progression received a variety of subsequent therapies. In the ADCETRIS arm, only eight of 51 patients (16%) receiving subsequent therapy were treated with ADCETRIS following relapse. In the placebo arm, 72 of 85 patients (85%) receiving subsequent therapy were treated with single agent ADCETRIS. Twenty-four patients in the placebo arm and 13 patients in the ADCETRIS arm received stem cell transplant as subsequent therapy, the majority of which were allogeneic transplants. OS data are immature, and no statistically significant difference in OS has been observed between the treatment arms (hazard ratio 1.15; p-value=0.62). A further analysis of overall survival is planned in 2016. The most common adverse events in the ADCETRIS arm were peripheral sensory neuropathy (56%), neutropenia (35%), upper respiratory tract infection (26%), fatigue (24%) and peripheral motor neuropathy (23%). The most common adverse events in the placebo arm were upper respiratory tract infection (23%), fatigue (18%) peripheral sensory neuropathy (16%), cough (16%) and neutropenia (12%). Eighty-five% of patients with peripheral neuropathy on the ADCETRIS arm had resolution or improvement in symptoms with a median time to improvement of 23.4 weeks. Grade 3 or higher adverse events in the ADCETRIS arm included neutropenia, peripheral sensory neuropathy, peripheral motor neuropathy, nausea, fatigue and diarrhea. Grade 3 or higher adverse events in the placebo arm included neutropenia, fatigue, peripheral motor neuropathy, diarrhea and peripheral sensory neuropathy. No Grade 4 peripheral neuropath y events occurred. One death occurred within 30 days of ADCETRIS treatment from treatment-related acute respiratory distress syndrome (ARDS) associated with pneumonitis. One death occurred on the ADCETRIS arm at Day 40 from ARDS following an episode of treatment-related acute pancreatitis, which had resolved at the time of death. Submission of safety data from the AETHERA trial to the FDA is a post-marketing requirement that Seattle Genetics will fulfill in its planned supplemental BLA. Takeda plans to submit data from the AETHERA trial to regulatory agencies in its territories.
Monash Institute of Pharmaceutical Sciences and Takeda Pharmaceutical Company Limited Announce Research Partnership to Tackle Human Gastrointestinal Diseases
Dec 9 14
The Monash Institute of Pharmaceutical Sciences and Takeda Pharmaceutical Company Limited (Takeda) announced a strategic research alliance to develop new medicines to address significant unmet medical needs in gastroenterology. Several gastrointestinal diseases and disorders in humans remain poorly understood and inadequately treated. Irritable bowel syndrome, abdominal pain, chronic itch, severe constipation and diarrhea are examples of some of the common and debilitating disorders that afflict millions of people worldwide and that will be the focus of the research alliance. Funding from Takeda will enable MIPS and Takeda scientists to work together to research the mechanisms that underlie these diseases and develop new and highly innovative approaches for their treatment. The collaboration between Monash and Takeda will focus on drug discovery, research and development of pharmaceutical products on potential therapeutic targets to treat gastrointestinal diseases and disorders.