Phase 3 trial for transplant-ineligible myeloma misses endpoint
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A randomized phase 3 trial designed to evaluate the addition of ixazomib to lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma ineligible for transplant failed to meet its primary endpoint, according to the agent’s manufacturer.
Ixazomib (Ninlaro, Takeda) is an oral proteasome inhibitor approved in the United States for use in combination with lenalidomide (Revlimid, Celgene) and dexamethasone for patients with multiple myeloma who received at least one previous therapy.
The double-blind, multicenter TOURMALINE-MM2 trial included 705 adults with newly diagnosed multiple myeloma who were not candidates for transplant.
Researchers assigned patients to lenalidomide and dexamethasone plus either ixazomib or placebo.
PFS served as the primary endpoint. Key secondary endpoints included complete response rate, pain response and OS.
Researchers reported numerically longer median PFS among ixazomib-treated patients (35.3 months vs. 21.8 months; HR = 0.83), but the difference did not reach statistical significance.
The safety profile of ixazomib appeared consistent with existing prescribing information.
Complete results from TOURMALINE-MM2 will be submitted for presentation at a medical meeting.
“There is a need for treatment options [for] transplant-ineligible patients. We remain committed to advancing the field of multiple myeloma and continue to drive innovation through ongoing research and development,” Christopher Arendt, head of the oncology therapeutic area unit for Takeda, said in a company-issued press release. “We are confident there will be numerous learnings from this trial and look forward to sharing these data with the community.”