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Takeda's Ninlaro fails to meet one of two primary endpoints in Phase 3 trial

Published on 06/06/19 at 11:02am

Takeda has decided to discontinue its Phase 3 study of Ninlaro (ixazomib) after the drug in combination with dexamethasone, failed to meet the first of two primary endpoints in the Phase 3 TOURMALINE-AL1 trial of patients with elapsed or refractory systemic light-chain (AL) amyloidosis.

“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,” said Dr Phil Rowlands, Head, Oncology Therapeutic Area Unit, Takeda.

“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.”

The TOURMALINE-AL1 was investigating the effectiveness of Ninlaro in combination with dexamethasone in improving hematologic response, 2-year vital organ (heart or kidney) deterioration and mortality rate in patients with amyloidosis.

Louis Goss

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