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Ixazomib extends PFS as first-line maintenance for certain patients with multiple myeloma
A randomized phase 3 trial designed to evaluate ixazomib as first-line maintenance therapy for adults with myeloma who did not undergo stem cell transplantation met its primary endpoint, according to the agent’s manufacturer.
Results of the TOURMALINE-MM4 trial showed patients assigned single-agent ixazomib (Ninlaro, Takeda) achieved significantly longer PFS than those assigned placebo.
The safety profile of ixazomib in the maintenance setting appeared consistent with prior studies of single-agent treatment with the agent. Researchers observed no new safety signals.
“We are very encouraged by the results of the TOURMALINE-MM4 trial and continue our forward momentum in developing maintenance options for [patients with multiple myeloma],” Phil Rowlands, PhD, head of the Oncology Therapeutic Area Unit at Takeda, said in a company-issued press release. “Importantly, this is the third positive phase 3 readout from the TOURMALINE clinical trial program. We remain committed to bringing this convenient and well-tolerated treatment option to patients.”
Ixazomib is an oral proteasome inhibitor approved in the United States for use in combination with lenalidomide (Revlimid, Celgene) and dexamethasone for the treatment of patients with previously treated multiple myeloma.
TOURMALINE-MM4 is the first industry-sponsored phase 3 trial to explore the concept of “switch” maintenance — or use of agents not included in initial induction therapy — in this setting, according to the Takeda press release.
The double-blind study included 706 adults with newly diagnosed multiple myeloma. All patients completed 6 to 12 months of initial therapy and achieved partial response or better. However, no patients underwent stem cell transplantation.
These topline data have not undergone peer review. Complete results from TOURMALINE-MM4 will be submitted for presentation at a medical meeting, and HemOnc Today and Healio.com will provide additional coverage when more data are available.