Takeda Pharmaceutical Company Limited announced that the company will feature a total of 14 Takeda Oncology-sponsored presentations at two upcoming medical meetings: the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO), June 1-5 in Chicago and the 23rd Congress of the European Hematology Association (EHA), June 14-17 in Stockholm.
This year’s presentations will underscore Takeda’s unwavering pursuit to advance hematologic cancer therapy and continue building upon research in difficult-to-treat solid tumors.
“At ASCO and EHA we will present data, real-world findings and trial updates on our pipeline assets as well as our marketed therapies,” said Christophe Bianchi, M.D., President, Takeda Oncology. “At ASCO, we will present updated Phase 2 ALTA trial results examining long-term efficacy and safety of ALUNBRIG in patients with ALK+ non-small cell lung cancer who are refractory to crizotinib. Notably, at EHA we will present data on pre-specified subgroups from the ECHELON-1 Phase 3 trial evaluating a combination with ADCETRIS as a frontline treatment for patients with Hodgkin lymphoma. Takeda’s research continues to push innovation in oncology to advance needed treatments and illustrates the company’s vision to improve the lives of cancer patients.”
At this year’s ASCO meeting, updated Phase 2 ALTA (ALK in Lung Cancer Trial of AP26113) trial results examining long-term efficacy and safety of ALUNBRIG® (brigatinib) in a crizotinib refractory anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) population will be presented. During the poster discussion presentations, TAK-788, a small molecule tyrosine kinase inhibitor targeting the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) mutations, including exon 20 insertions, will report on the safety, pharmacokinetics and preliminary antitumor activity of this molecule in NSCLC patients. In addition, results from a first-in-human Phase 1 study of TAK-931, a small molecule inhibitor of the CDC7 kinase activity, in patients with advanced solid tumors will be shared during the oral presentations. The trial, which investigates the effect of TAK-931 in up to 100 participants with solid tumors, examines the safety, tolerability and pharmacokinetics of the oral medication to determine the maximum tolerated dose.
The company also continues to deepen its scientific body of knowledge in hematologic cancers. At ASCO, the company will present a “Trials in Progress” poster on the ongoing randomized global Phase 3 trial, PANTHER (investigational intravenous Pevonedistat plus Azacitidine versus single-agent azacitidine as first-line Treatment for patients with Higher-Risk myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia or low-blast acute myelogenous leukemia (AML)).
Furthermore, at this year’s EHA meeting, data on the efficacy and safety of a combination with ADCETRIS® (brentuximab vedotin) in pre-specified subgroups with more advanced disease from the ECHELON-1 trial will be presented. Data demonstrate greater benefit across these subgroups compared to the intent to treat population regardless of PET2 status based on the primary endpoint of modified progression-free survival. In addition, encore data from the Phase 3 ECHELON-1 clinical trial evaluating ADCETRIS as part of a frontline combination chemotherapy regimen in previously untreated advanced stage Hodgkin lymphoma will be featured. The data was previously presented in the Plenary Session at the 59th American Society of Hematology (ASH) Annual Meeting in December 2017. Finally, a study of TAK-659, a reversible dual inhibitor of spleen tyrosine kinase (SYK) and FMS-like tyrosine kinase-3 (FLT3), in combination with standard of care treatments will present preliminary safety and efficacy data in diffuse large B-cell lymphoma models.
Safety, efficacy and real-world use findings from Takeda Oncology-sponsored trials examining a variety of blood cancers, including lymphoma, multiple myeloma and MDS, will be featured at ASCO and / or EHA.
The six Takeda Oncology-sponsored abstracts accepted for presentation during ASCO 2018 and eight abstracts at EHA 2018 include:
ASCO Annual Meeting 2018
ADCETRIS (brentuximab vedotin)
Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin Lymphoma (HL): Impact of Cycle 2 PET Result on Modified Progression-Free Survival. Abstract 7539. Monday, June 4, 8:00-11:30 a.m., Hall A.
Improving Outcomes with Brentuximab Vedotin (BV) plus Chemotherapy in Patients with Newly Diagnosed Advanced Stage Hodgkin Lymphoma. Abstract 7534. Monday, June 4, 8:00-11:30 a.m., Hall A.
ALUNBRIG (brigatinib)
Brigatinib (BRG) in Crizotinib (CRZ)-Refractory ALK+ Non–Small Cell Lung Cancer (NSCLC): Efficacy Updates and Exploratory Analysis of CNS ORR and Overall ORR by Baseline (BL) Brain Lesion Status. Abstract 9061. Sunday, June 3, 8:00-11:30 a.m., Hall A.
Pipeline
First-in-Human Phase 1 Study of TAK-931, an Oral Cell Division Cycle 7 (CDC7) Inhibitor in Patients (Pts) with Advanced Solid Tumors. Abstract 2506. Oral presentation. Friday, June 1, 4:09-4:21 p.m., S406.
First Report of Safety, PK and Preliminary Antitumor Activity of the Oral EGFR/HER2 Exon 20 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer (NSCLC). Abstract 9015. Sunday, June 3, 11:30 a.m.-12:45 p.m., Hall A.
Phase 3 Study of First Line Pevonedistat (PEV) + Azacitidine (AZA) versus Single-Agent AZA in Patients with Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) or Low-Blast Acute Myelogenous Leukemia (AML). Abstract TPS7077. Monday, June 4, 8:00-11:00 a.m., Hall A.
EHA 23rd Congress
ADCETRIS (brentuximab vedotin)
Brentuximab Vedotin Plus Chemotherapy in High Risk Advanced-Stage Classical Hodgkin Lymphoma (CHL) Patients: Results of Pre-Specified Sub-Group Analyses from the ECHELON-1 Study. Abstract S112. Oral presentation. Friday, June 15, 12:00-12:15 p.m., Room A2.
Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin Lymphoma: Impact of Cycle 2 PET Modified Progression-Free Survival. Abstract PS1172. Saturday, June 16, 5:30-7:00 p.m., Poster Area.
Frontline Brentuximab Vedotin Plus Chemotherapy Exhibits Superior Modified Progression-Free Survival vs Chemotherapy Alone in Patients with Stage III or IV Hodgkin Lymphoma: Phase 3 ECHELON-1 Study. Abstract PS1182. Saturday, June 16, 5:30-7:00 p.m., Poster Area.
Brentuximab Vedotin in Relapsed/Refractory Systemic Anaplastic Large-Cell Lymphoma: A Cost-Effectiveness Analysis. Abstract PF684. Friday, June 15, 5:30-7:00 p.m., Poster Area.
NINLARO (ixazomib)
A Global Treatment Standard in Multiple Myeloma (MM) Remains Elusive Despite Advances in Care Over 15 Years: First Results from INSIGHT MM, the Largest Global Prospective, Observational MM Study. Abstract PS1300. Saturday, June 16, 5:30-7:00 p.m., Poster Area.
Randomized Clinical Trial (RCT) Representativeness & Outcomes in Relapsed/Refractory Multiple Myeloma (RRMM) Real World (RW) Patients: Comparison of ASPIRE, TOURMALINE-MM1, POLLUX & ELOQUENT RCTS. Abstract PS1336. Saturday, June 16, 5:30-7:00 p.m., Poster Area.
Pipeline
Phase 1/1b Study of Pevonedistat (PEV) as a Single Agent or Combined with Azacitidine (AZA) in East Asian Patients (Pts) with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). Abstract PS997. Saturday, June 16, 5:30-7:00 p.m., Poster Area.
TAK-659 Plus Bendamustine (+/-Rituximab), Gemcitabine, Lenalidomide or Ibrutinib in Patients (Pts) with Advanced Non-Hodgkin Lymphoma (NHL). Abstract PF281. Friday, June 15, 5:30-7:00 p.m., Poster Area.
For more information, please see ASCO (https://am.asco.org/program) and EHA (http://eha-2018.org/) online programs.
About ADCETRIS
ADCETRIS 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-positive tumor cells.
ADCETRIS injection for intravenous infusion has received FDA regular approval for five indications in adult patients with: (1) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy, (2) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (3) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (4) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (5) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.
Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplant (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.
ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, and (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
ADCETRIS has received marketing authorization by regulatory authorities in more than 70 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See important safety information below.
ADCETRIS is being evaluated broadly in more than 70 clinical trials, including a Phase 3 study in frontline Hodgkin lymphoma (ECHELON-1) and another Phase 3 study in frontline CD30-positive peripheral 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 U.S. 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.
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and neuroscience therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. Innovative products, especially in oncology and gastroenterology, as well as Takeda’s presence in emerging markets, are currently fueling the growth of Takeda. Approximately 30,000 Takeda employees are committed to improving quality of life for patients, working with Takeda’s partners in health care in more than 70 countries.
