IS6-8 - Recent Data from Investigational Programs in Hematologic Malignancies and Prostate Cancer from Millennium: The Takeda Oncology Company

Abstract

ABSTRACT Background Recent data from clinical trials of three investigational agents and one recently approved agent are summarized: MLN9708, an oral, reversible 20S proteasome inhibitor being evaluated for multiple myeloma (MM); MLN8237 (alisertib), an aurora A kinase inhibitor, under investigation in hematologic malignancies and solid tumors; brentuximab vedotin (ADCETRIS), an anti-CD30 antibody–drug conjugate recently approved by the FDA for relapsed or refractory (rel/ref) systemic anaplastic large cell lymphoma (sALCL) and Hodgkin lymphoma (HL); and orteronel (TAK-700), a non-steroidal 17,20-lyase inhibitor, in development for patients with castration-resistant prostate cancer (CRPC). Methods and results Preliminary data from a phase (ph) 1/2 study of weekly MLN9708 in combination with standard dose lenalidomide and dexamethasone in patients with previously untreated MM were presented at ASH 2011 (Berdeja et al. Abs. 479). Studies are ongoing to evaluate both oral and IV formulations of MLN9708 in a variety of solid tumors and hematologic malignancies. Ph 2 data on MLN8237 in patients with rel/ref aggressive T- and B-cell lymphomas were presented at ASH 2011 (Friedberg et al. Abs. 97). Based on the results of this study, a ph 3 trial in rel/ref peripheral T-cell lymphoma has been initiated. Recent ph 2 data for brentuximab vedotin in rel/ref sALCL and HL, supporting its FDA approval, were presented at ASH 2011 (Advani et al., Abs. 443) and ICML 2011 (Younes et al., Abs. 160), respectively. Ongoing studies with brentuximab vedotin in HL include a ph 3 trial in high-risk patients following ASCT, ph 1 studies investigating front-line use in combination with multi-agent chemotherapy, and a ph 1/2 study in rel/ref HL and sALCL in Japanese patients. A recent ph 2 study of orteronel without prednisone in patients with non-metastatic CRPC and rising prostate-specific antigen levels was presented at EAU 2012 (Hussain et al., Abs. 124). Ongoing studies in metastatic CRPC include two ph 3 studies in the chemotherapy-naive and post docetaxel settings, and a ph 1/2 study in combination with docetaxel and prednisone. Conclusions Millennium/Takeda (in collaboration with Seattle Genetics for brentuximab vedotin) has a broad range of oncology clinical development programs in multiple indications; the latest clinical data will be summarized.