Takeda Pharmaceutical to present oncology data at ASH

Takeda Pharmaceutical announced that it will present 22 company-sponsored abstracts at the American Society of Hematology, or ASH, annual meeting, being held virtually December 5-8. The company's scientific research at ASH will identify approaches in advancing the treatment of hematologic cancers. Takeda will also be presenting data from its broader hematology portfolio and pipeline at the conference. A sub-analysis from the Phase 2 Pevonedistat-2001 trial will be presented in an oral session. The analysis, which focused on outcomes of the higher-risk myelodysplastic syndromes, or MDS, subgroup of the study, showed that the combination of pevonedistat and azacitidine resulted in longer event-free survival, longer duration of response and delayed transformation to acute myeloid leukemia without increasing myelosuppression, compared to treatment with azacitidine alone. Additionally, the safety profile of pevonedistat and azacitidine in combination was comparable to azacitidine alone. Despite poor outcomes, there have been no novel advances in higher-risk MDS treatment in over 10 years and new, effective therapies with favorable safety profiles that do not worsen myelosuppression are needed. Data from the interim analysis of the OPTIC trial of ICLUSIG will be presented in an oral session. The data highlighted the revised benefit-risk of ICLUSIG, a third-generation tyrosine kinase inhibitor (TKI), with the use of a response-based dosing regimen in resistant chronic-phase chronic myeloid leukemia, or CP-CML, patients, with or without mutations, who have experienced treatment failure with second-generation, or 2G, TKIs. Another oral presentation will feature a pooled sub-analysis highlighting patients from the PACE and OPTIC trials, comprising the largest patient population evaluation in a post-2G TKI setting. While CP-CML is often manageable, patients who have experienced treatment failure with prior 2G TKI therapy, especially those who are resistant to therapy, suffer from poor long-term outcomes, underscoring that there are still gaps in care for people living with CP-CML. Results from the TOURMALINE-MM2 trial will be presented in an oral session. The study was designed to evaluate the addition of NINLARO to lenalidomide and dexamethasone in newly diagnosed transplant ineligible multiple myeloma patients. While the trial did not meet the threshold for statistical significance and the primary endpoint of progression-free survival, or PFS, was not met, the study found the addition of NINLARO resulted in a 13.5 month increase in median PFS overall. In the prespecified expanded high-risk cytogenetics subgroup, the addition of NINLARO resulted in a median PFS of 23.8 months versus 18.0 months in the placebo arm. Newly diagnosed multiple myeloma patients are in need of additional proteasome inhibitor-based treatment options, as there are currently no approved options that are all-oral. Five-year follow up data from two Phase 3 frontline lymphoma studies will be featured as poster presentations. Data from the ECHELON-1 trial, which evaluated ADCETRIS in combination with doxorubicin, vinblastine and dacarbazine for previously untreated, stage III/IV Hodgkin lymphoma shows that, with extended follow-up time, the addition of ADCETRIS to AVD demonstrates a robust and sustained treatment benefit, independent of disease stage, International Prognostic Index risk factor score and PET2 status compared to ABVD, the current standard of care. Positive final analyses from ECHELON-2 which evaluated ADCETRIS in combination with CHP versus a standard care treatment in frontline treatment of patients with CD30-positive peripheral T-cell lymphoma will also be presented. The safety profile of ADCETRIS in the ECHELON-1 and ECHELON-2 trials were consistent with the established safety profile of ADCETRIS in combination with chemotherapy.