Takeda Pharmaceutical has announced plans to discontinue its Phase III TOURMALINE-AL1 clinical trial of Ninlaro (ixazomib) in amyloidosis after the study failed to meet the first of two primary endpoints.
The trial involved patients with relapsed or refractory systemic light-chain (AL) amyloidosis. Participants did not show significant improvement in overall haematologic response with Ninlaro and dexamethasone.
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During the study, the drug combination was compared to specific standard of care regimens.
The company noted that an Independent Data Monitoring Committee (IDMC) raised no concerns regarding the Ninlaro’s safety profile in this setting.
Takeda Pharmaceutical oncology therapeutic area unit head Phil Rowlands said: “While we are disappointed with this outcome, we aim to maximise our learnings from this trial and share findings with the community in hopes of helping to improve care for patients living with this devastating disease.
“We remain optimistic about Ninlaro and continue to investigate Ninlaro in patient populations across the continuum of multiple myeloma care.”
Ninlaro is an oral proteasome inhibitor being developed across the continuum of multiple myeloma treatment settings.
It secured the first US Food and Drug Administration (FDA) approval in November 2015 for use with lenalidomide and dexamethasone in multiple myeloma patients who had at least one previous therapy.
The randomised, controlled, open-label, multi-centre TOURMALINE-AL1 trial assessed the ability of the Ninlaro and dexamethasone combination to improve haematologic response, two-year vital organ (heart or kidney) deterioration and mortality.
The combination was compared to dexamethasone and melphalan, dexamethasone and cyclophosphamide, dexamethasone and thalidomide, dexamethasone and lenalidomide, or dexamethasone alone.
Primary endpoints of the study were the proportion of patients with overall haematologic response, and two-year vital organ deterioration and mortality rate.
