Reshaping the Future of Blood Cancer Treatments – 59th American Society of Hematology

Atlanta skyline at sunny morning, Georgia, USA

During the oncoming 59th annual meeting of the American Society of Hematology (ASH) in Atlanta, GA, which will be held December 9 to 12, 2017, Takeda Oncology will present a total of 11 company-sponsored abstracts, showcasing data that may reshape the future of blood cancer treatments.

Data from Phase III and earlier-stage clinical studies across the company?s broadened oncology portfolio will be featured.

Among the data to be presented is the full data from the Phase III ECHELON-1 clinical trial evaluating brentuximab vedotin (Adcetris?; Seattle Genetics/Takeda Oncology) as part of a frontline combination chemotherapy regimen in patients with previously untreated advanced Hodgkin lymphoma.

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.

Plenary Scientific Session
The data will be presented for the first time in the Plenary Scientific Session in collaboration between Takeda Oncology in partnership with Seattle Genetics. Topline data from ECHELON-1, which was reported in June 2016, demonstrated that the trial met its primary endpoint of a statistically significant improvement in modified Progression-Free Survival (PFS) versus the control arm, representing a milestone in the frontline treatment of advanced Hodgkin lymphoma.

The two-year modified PFS rate for patients in the brentuximab vedotin arm was 82.1% compared to 77.2 percent in the control arm (HR=0.770; p-value=0.035). The safety profile of brentuximab vedotin+AVD in the ECHELON-1 trial was consistent with that known for the single-agent components of the regimen. In addition, updated analyses of the Phase III ALCANZA data will be featured, showing that longer-term data continued to show significant clinical benefit for brentuximab vedotin versus investigator?s choice of methotrexate or bexarotene.


Brentuximab vedotin?(Adcetris?)
Brentuximab Vedotin Plus Doxorubicin, Vinblastine, Dacarbazine (A+AVD) as Frontline Therapy Demonstrates Superior Modified Progression-Free Survival Versus ABVD in Patients with Previously Untreated Stage III or IV Hodgkin Lymphoma (HL): The Phase 3 ECHELON-1 Study.Plenary Scientific Session. Sunday, December 10, 2017, 2:00 ? 4:00 p.m. (Georgia World Congress Center, Building C, Level 1, Hall C2-C3).
Updated Analyses of the International, Open-Label, Randomized, Phase 3 ALCANZA Study: Longer-Term Evidence for Superiority of Brentuximab Vedotin Versus Methotrexate or Bexarotene for CD30-Positive Cutaneous T-cell Lymphoma (CTCL).Abstract 1509. Saturday, December 9, 2017, 5:30 ? 7:30 p.m. (Georgia World Congress Center, Building A, Level 1, Hall A2).
Patient and Physician Preferences for Front-Line Treatment of Advanced Stage Hodgkin Lymphoma in Germany, France and the United Kingdom.Abstract 4082. Monday, December 11, 2017, 6:00 ? 8:00 p.m. (Georgia World Congress Center, Building A, Level 1, Hall A2).

?This year at ASH, we are presenting data that truly has the potential to change how patients with blood cancers are treated,? said Christophe Bianchi MD., President, Takeda Global Oncology Business Unit.

?The positive data from the ECHELON-1 trial represents a milestone in the frontline treatment of advanced Hodgkin lymphoma ? a population in which one in three patients doesn?t achieve long-term remission after standard frontline therapy. Furthermore, the real-world data in multiple myeloma we will share will help the community to better understand discrepancies between effectiveness and efficacy in clinical trials versus real-world,? Bianchi added.

Multiple myeloma
Takeda will also share real-world data in multiple myeloma, helping the community to better understand discrepancies between effectiveness and efficacy in clinical trials versus real-world, as well as data on long-term ixazomib (Ninlaro?) maintenance therapy in patients with newly diagnosed multiple myeloma not undergoing a stem cell transplant.


Ixazomib?(Ninlaro?)
Efficacy and Safety of Long-Term Ixazomib Maintenance Therapy in Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM) Not Undergoing Transplant: An Integrated Analysis of Four Phase 1/2 Studies.Abstract 902. Oral Presentation. Monday, December 11, 2017, 6:30 p.m. (Georgia World Congress Center, Building C, Level 1, Hall C4).
Real-World and Clinical Trial Data in Relapsed/Refractory Multiple Myeloma (RRMM): Evaluating Treatment Duration and Comparing Effectiveness and Efficacy.Abstract 3149. Sunday, December 10, 2017, 6:00 ? 8:00 p.m. (Georgia World Congress Center, Building A, Level 1, Hall A2).
Duration of Therapy (DOT) and Time to Next Therapy (TTNT) of Bortezomib, Carfilzomib and Ixazomib Combinations with Lenalidomide/Dexamethasone (VRd, KRd, IRd) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Clinical Practice in the United States Vs Clinical Trial Experience.Abstract 1818. Saturday, December 9, 2017, 5:30 ? 7:30 p.m. (Georgia World Congress Center, Building A, Level 1, Hall A2).
Costs Associated with Productivity Loss Among U.S. Patients Newly Diagnosed with Multiple Myeloma Receiving Oral Versus Injectable Chemotherapy.Abstract 3423. Sunday, December 10, 2017, 6:00 ? 8:00 p.m. (Georgia World Congress Center, Building A, Level 1, Hall A2).

Chronic myeloid leukemia
In addition to these presentations, Takeda Oncology will present five-year data from the pivotal Phase II PACE study of ponatinib (Iclusig?), which demonstrated that the treatment continued to yield deep, durable, and clinically meaningful responses in patients with the chronic phase of chronic myeloid leukemia (CP-CML).


Ponatinib (Iclusig?)
Efficacy and Safety of Ponatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) According to the Extent of Treatment with Prior Tyrosine Kinase Inhibitors (TKIs): Final (5-Year) Results of the PACE Study.Abstract 1617. Saturday, December 9, 2017, 5:30 ? 7:30 p.m. (Georgia World Congress Center, Building A, Level 1, Hall A2).
Arterial Occlusive Events (AOEs) in the Phase 2 Ponatinib PACE Trial: 5-Year Update in Heavily Treated Patients (Pts) with Chronic-Phase Chronic Myeloid Leukemia (CP-CML).Abstract 2896. Sunday, December 10, 2017, 6:00 ? 8:00 p.m. (Georgia World Congress Center, Building A, Level 1, Hall A2).

Finally, the company is also expected to present trial results of a number of pipeline products.


Phase 1 Study of TAK-659, an Investigational Reversible Dual SYK/FLT-3 Inhibitor, in Patients (Pts) with Lymphoma: Updated Results from Dose-Escalation and Expansion Cohorts.Abstract 1554. Saturday, December 9, 2017, 5:30 ? 7:30 p.m. (Georgia World Congress Center, Building A, Level 1, Hall A2).
A Phase (ph) 1b/2 Study of TAK-659, an Investigational Dual FLT-3 and SYK Inhibitor, in Patients (Pts) with Relapsed or Refractory Acute Myelogenous Leukemia (R/R AML).Abstract 2622. Sunday, December 10, 2017, 6:00 ? 8:00 p.m. (Georgia World Congress Center, Building A, Level 1, Hall A2).

Last Editorial Review: November 22, 2017

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