Phase III clinical trial TOURMALINE-AL1 discontinued

Takeda has stopped the phase III TOURMALINE-AL1 clinical trial in patients with relapsed or refractory AL amyloidosis because treatment with NINLARO (ixazomib) in combination with dexamethasone did not demonstrate a significant improvement in overall hematologic response compared to other choices of standard of care regimens, which was the first of two primary endpoints. An Independent Data Monitoring Committee did not raise any concerns about the safety profile of NINLARO in this setting.

Phil Rowlands, Takeda’s Head of Oncology Therapeutics, said: “While we are disappointed with this outcome, we aim to maximize 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. This has been one of the largest studies ever conducted in systemic light-chain AL amyloidosis and we are proud to have led it. This study demonstrated our dedication to this rare and traditionally difficult-to-enroll patient population and we thank the patients and investigators for their engagement and participation. We remain optimistic about NINLARO and continue to investigate NINLARO in patient populations across the continuum of multiple myeloma care.”