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Takeda’s ixazomib comes up short in first-line multiple myeloma study

September 10, 2020

A Phase 3 clinical trial, TOURMALINE-MM2, evaluating Takeda Pharmaceutical Company Limited’s (NYSE:TAK) Ninlaro (ixazomib), added to lenalidomide (sold as Revlimid by Celgene) and dexamethasone (l+d), in newly diagnosed (first-line) multiple myeloma (MM) patients ineligible for autologous stem cell transplant failed to achieve the primary endpoint. The results were virtually presented at the Society of Hematologic Oncology Annual Meeting.

The addition of Ninlaro, a proteasome inhibitor, to l+d increased median progression-free survival (PFS) 13.5 months to 35.3 months compared to 21.8 months in the placebo/l+d arm, but the separation was not statistically significant (p=0.073).

The complete response rate – a key secondary endpoint – in the ixazomib arm was 26%, compared to 14% in the placebo arm.

Median overall survival (OS) was not reached in either arm.

No new safety signals were observed. The rate of serious or greater treatment-emergent adverse events was 88.1% in the Ninlaro group versus 81.4% in the control group. The discontinuation rate in the Ninlaro arm was 35% compared to 27% in the placebo arm. The mortality rate was greater in the Ninlaro group, 7.6% vs. 6.3%.

Ninlaro is currently approved in combination with l+d for MM patients who have received at least one prior line of therapy.

Takeda secured the rights to Ninlaro via its $8.8B acquisition of Millennium Pharmaceuticals in 2008.

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