Phase III TOURMALINE-MM3 Trial of Ixazomib as Maintenance Therapy in Patients With Multiple Myeloma Posttransplant
The randomized, phase III TOURMALINE-MM3 study met its primary endpoint, demonstrating single-agent oral ixazomib (Ninlaro) as a maintenance therapy resulted in a statistically significant improvement in progression-free survival (PFS) vs placebo. The trial evaluated the effect of ixazomib as a maintenance therapy in adult patients diagnosed with multiple myeloma who responded to high-dose therapy (HDT) and autologous stem cell transplant (ASCT).
“Within the maintenance setting, it is critical that we find agents that are efficacious, tolerable, and convenient,” said Jesús Gomez Navarro, MD, Vice President, Head of Oncology Clinical Research and Development, Takeda. “The results of the TOURMALINE-MM3 trial represent an important step toward the goal of expanding the use of ixazomib as a maintenance therapy. This is the first and only phase III placebo-controlled study evaluating a proteasome inhibitor in this setting, and we look forward to discussions with Health Authorities around the world.”
There were no new safety signals found in TOURMALINE-MM3. The safety profile of ixazomib in the maintenance setting is consistent with previously reported results of single-agent ixazomib use.
Full data results will be submitted for presentation at the 60th American Society of Hematology Annual Meeting in December.
More About the TOURMALINE-MM3 Trial
TOURMALINE-MM3 is a randomized, placebo-controlled, double-blind phase III study of 656 patients designed to determine the effect of ixazomib maintenance therapy on PFS—compared to placebo—in participants with multiple myeloma who have had a response (complete response, very good partial response, or partial response) to induction therapy followed by HDT and ASCT.
The primary endpoint is progression-free survival, and a key secondary endpoint is overall survival.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
