30May

Phase III TOURMALINE-MM4 : Ixazomib vs placebo maintenance for newly diagnosed multiple myeloma patients not undergoing ASCT

Ixazomib vs placebo maintenance for newly diagnosed multiple myeloma (NDMM) patients not undergoing autologous stem cell transplant (ASCT): The phase III TOURMALINE-MM4 trial.


Abstract No : 8527

Abstract Type : Poster Discussion Session

Indication : Multiple Myeloma

Intervention : Ixazomib

Company : Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda

Technology : Small molecule


Results:

Baseline characteristics were well balanced. Overall median age was 73 yrs, 38% of patients were aged ≥75 yrs, 35% were ISS stage III, and 22%/40%/38% had CR/VGPR/PR post induction. Overall, 82% of patients received a PI and 33% an immunomodulatory drug as part of their induction regimen. At a median follow-up of 21.1 months, median PFS was 17.4 months with ixazomib vs 9.4 months with placebo (hazard ratio [HR] 0.659, 95% confidence interval [CI] 0.542–0.801, p < 0.001). Significant (p < 0.001) PFS benefit was seen in patients who achieved CR/VGPR post induction (Table). Overall survival data are not yet mature (19% of events); follow-up is ongoing. Treatment-emergent adverse events (TEAEs) were mostly grade 1–2 (37% vs 23% of patients had grade ≥3 TEAEs with ixazomib vs placebo). Common TEAEs for ixazomib vs placebo included nausea (27% vs 8%), vomiting (24% vs 4%), and diarrhea (23% vs 12%); 5% vs 6% of patients had new primary malignancies. No cumulative toxicities were observed.


Conclusion:

Ixazomib maintenance therapy in nonASCT NDMM patients showed a clinically meaningful 34% reduction in the risk of progression or death, with a well-tolerated safety profile. Ixazomib is the first oral PI maintenance option for non-ASCT NDMM patients.


Commentary:

Ixazomib, first oral PI maintenance option for Non ASCT patients in NDMM, has demonstrated clinically meaningful PFS improvement