· The company announced that the clinical trial failed to fulfil the first of the two preestablished endpoints.

· Citing the result of the analysis, Takeda Pharma has decided to permanently halt the trial.

Takeda Pharmaceutical Company Ltd. (Takeda Pharma), a renowned Japanese pharmaceutical company, has reportedly released a new update on its ongoing Phase-3 TOURMALINE-AL1 clinical trial in individuals suffering from refractory or relapsed systemic light-chain amyloidosis.

Reports cite, the clinical trial failed to fulfil the first of the two preestablished endpoints, wherein an assessment of treatment through a combination of dexamethasone & NINLAROTM (ixazomib).

According to a report by Financial Post, the combination treatment failed to demonstrate any substantial improvement in the patients overall hematologic response as compared to a physician’s preferred standard of care.

The Head of Oncology Therapeutic Area Unit at Takeda, Phil Rowlands, Ph.D., stated that while the company is disappointed with the outcome of the trial, it still aims to maximize its own learnings from the trial and further share any findings with the community with the intention that it would help improve care for individuals that are living with the debilitating disease.

The trial was one of the biggest studies to be ever conducted for systemic light-chain AL amyloidosis, demonstrating the company’s dedication in finding a cure for the rare disease with a patient population that is conventionally difficult to enroll.

Meanwhile, the company remains optimistic regarding NINLARO as an individual entity and would continue to investigate the candidate in patients across the sequence of multiple-myeloma care.

While an Independent Data Monitoring Committee (IDMC) has not raised any concerns about NINLARO’s safety, patients are still encouraged to approach their respective study investigators to address any queries.

According to reports, citing the result of the dexamethasone & NINLARO combination treatment analysis, Takeda Pharma has decided to permanently halt the clinical trial.

Source Credit: https://www.takeda.com/newsroom/newsreleases/2019/takeda-provides-update-on-tourmaline-al1-phase-3-trial/