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Takeda's Ninlaro combo fails to hit main goal in newly diagnosed, transplant ineligible multiple myeloma

Takeda has unveiled new Phase 3 data for its oral proteasome inhibitor Ninlaro (ixazomib) in the treatment of newly diagnosed transplant ineligible multiple myeloma, revealing that the therapy, when combined with lenalidomide and dexamethasone, unfortunately did not meet its primary endpoint.

The combo was shown to improve median progression-free survival by 35.3 months compared to 21.8 months with lenalidomide and dexamethasone alone – an overall improvement of 13.5 months, but this was not to a degree that was considered statistically significant.

Takeda's Ninlaro shows progression-free survival benefit in multiple myeloma

Takeda has revealed strong new findings for Ninlaro (ixazomib), confirming that the therapy met its primary endpoint as a first-line maintenance treatment of multiple myeloma in adult patients not treated with stem cell transplantation.

In a Phase 3 study incorporating 706 multiple myeloma patients who had completed 6-12 months of initial therapy and achieved a partial response or better, Ninlaro demonstrated a “statistically significant” improvement in progression free survival compared to placebo, meeting its primary endpoint.

Takeda's Ninlaro clears Phase 3 endpoint as maintenance therapy in multiple myeloma

After making headlines with its mammoth deal to acquire Shire earlier this year, Takeda has emerged with new Phase 3 data for its oral proteasome inhibitor Ninlaro (ixazomib).

The findings showed that the drug met its primary endpoint with a statistically significant improvement in progression-free survival (PFS) versus placebo as a maintenance therapy for multiple myeloma in adult patients who responded to high-dose therapy (HDT) and autologous stem cell transplant (ASCT).  

Takeda's Ninlaro knocked back by NICE for second time

NICE has revealed that the outcome of its consultation process for Ninlaro (ixazomib), Takeda’s treatment for relapsed or refractory multiple myeloma, was to reject the drug for the second time in the indication.

The sticking point, as is often the case with NICE, was based on cost-effectiveness, with concerns that the company did not have enough data to significantly back up its claims that it prolongs life compared with current treatments.

Takeda in myeloma research drive

The Phase II study will trial Ninlaro in combination in patients with myeloma

Takeda is funding the research charity Myeloma UK to run a Phase II study of its multiple myeloma treatment Ninlaro, which is open for recruitment.

The Japanese pharma firm is backing Myeloma UK to investigate the benefits of Ninlaro (ixazomib), in combination with cyclophosphamide and dexamethasone, against a combination of cyclophosphamide and dexamethasone in relapsed and/or refractory myeloma patients.

Takeda’s Ninlaro extends myeloma survival in trial


Takeda has presented trial data showing that treatment with its oral proteasome inhibitor Ninlaro extended progression free survival by 35% in patients with relapsed and/or refractory multiple myeloma.

The TOURMALINE-MM1 trial of 722 patients compared the performance of once-weekly oral Ninlaro (ixazomib) plus Celgene’s Revlimid (lenalidomide) and dexamethasone compared to placebo plus lenalidomide and dexamethasone.

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