Takeda to present data from clinical trials on patients with multiple myeloma

Takeda Pharmaceutical Company Limited announced that data from two Phase 1/2 clinical trials evaluating NINLARO (ixazomib) in patients with newly diagnosed multiple myeloma will be presented during sessions at the 2017 European Hematology Association (EHA) annual meeting.

Both studies evaluated NINLARO plus lenalidomide and dexamethasone in newly diagnosed patients with multiple myeloma who did not undergo stem cell transplant (SCT), followed by maintenance with single-agent ixazomib. NINLARO is currently not approved for the treatment of newly diagnosed multiple myeloma or in the maintenance setting.

“Despite recent progress, multiple myeloma remains a rare, devastating and incurable hematologic cancer. Data being presented at EHA demonstrate Takeda’s ongoing commitment to exploring new ways to provide effective and sustainable treatment for patients with multiple myeloma, both at the time of diagnosis and for long-term use,” said Jesus Gomez Navarro, M.D., vice president and head of Oncology Clinical Research and Development at Takeda.

“These Phase 1/2 data demonstrate the potential use of ixazomib in combination with lenalidomidedexamethasone in newly diagnosed multiple myeloma and as a single-agent maintenance therapy, which resulted in patients achieving deepening responses with continual use of the treatment. Ixazomib’s efficacy and safety profile — coupled with its administration as a completely oral regimen — potentially can reduce some logistical burdens, and help patients be able to sustain a multiple myeloma therapy.”

In the Phase 1/2 study, patients with newly diagnosed multiple myeloma received weekly oral ixazomib (1.68 - 3.95 mg/m2 in Phase 1 and 4.0 mg in Phase 2) plus lenalidomide and dexamethasone for up to twelve, 28-day induction cycles.

Of the 65 enrolled patients, 42 continued on study treatment without withdrawing early for SCT. After initial therapy, 25 patients went on to receive weekly, single-agent ixazomib at the last tolerated dose given during induction until disease progression or unacceptable toxicity.