Takeda Pharmaceutical Company Limited announced that it will present a total of 16 company-sponsored abstracts at the 58th American Society of Hematology (ASH) Annual Meeting taking place in San Diego from December 3 to 6, 2016. Takeda’s presentations at this year’s meeting will feature phase 3 and earlier-stage data from clinical studies across the company’s broad haematology-oncology portfolio.

“Even as we convene at ASH to discuss the latest innovations in haematology, we recognize that there is still a need for additional effective, convenient and sustainable therapies that address the issues impacting patients and their families on a daily basis,” said Christophe Bianchi MD, president, Takeda Global Oncology Business Unit. “The data we are presenting this year illustrate our enduring commitment to the development and evaluation of therapies that may transform patient care across various types of complex and refractory blood cancers – lymphoma, multiple myeloma, myelodysplastic syndromes and more. From our phase 3 Ninlaro and Adcetris programs to our earliest preclinical studies, we hope to continue to make strides toward fulfilling unmet needs and providing additional treatment options for patients with hematologic malignancies in the future.”

Takeda will present on a wide range of topics, including full data from the phase 3 ALCANZA study of Adcetris in CD30-positive cutaneous T-cell lymphoma, as well as 5-year overall survival data for the pivotal phase 2 study of Adcetris in systemic Anaplastic Large Cell Lymphoma (sALCL) in partnership with Seattle Genetics for the first time. The company also plans to share new data from a post-hoc biomarker analysis for the phase 3 TOURMALINE-MM1 trial, exploring the association between expression of the c-MYC gene and improved progression-free survival in patients with relapsed and/or refractory multiple myeloma receiving a regimen of Ninlaro plus lenalidomide and dexamethasone versus the placebo regimen.

In addition to investigational data for Ninlaro and Adcetris, several presentations on findings from clinical studies will highlight the scope of Takeda’s research and development organization. The company will share analyses on pevonedistat, a first-in-class selective inhibitor of the NEDD8-activating enzymes in a clinical trial for myelodysplastic syndromes and acute myeloid leukemia. This inhibitor disrupts cullin-ring ligase mediated protein turnover leading to apoptosis in cancer cells. Further, Takeda will present findings from studies of TAK-659, an investigational dual inhibitor of SYK and FLT-3 kinases, for the treatment of various types of lymphoma and acute myeloid leukaemia.

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

Adcetris was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). In January 2016, the European Commission approved a Type II variation to include data on the retreatment of adult patients with Hodgkin lymphoma or sALCL who previously responded to Adcetris and who later relapse. In June 2016, the European Commission extended the current conditional approval of Adcetris and approved Adcetris for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT. Adcetris has received marketing authorization by regulatory authorities in 65 countries.

ADCETRIS is being evaluated broadly in more than 45 ongoing clinical trials, including the phase 3 ALCANZA trial in CD30-positive cutaneous T cell lymphoma (CTCL) and two additional phase 3 studies, one in frontline classical Hodgkin lymphoma (ECHELON-1) and one in frontline CD30-positive mature T-cell lymphomas (ECHELON-2), as well as trials in many additional types of CD30-positive malignancies.

Seattle Genetics and Takeda are jointly developing Adcetris. Under the terms of the collaboration agreement, Seattle Genetics has US and Canadian commercialization rights and Takeda has rights to commercialize Adcetris in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for Adcetris on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL). Adcetris is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).