A combination of Ninlaro (ixazomib), Revlimid (lenalidomide), and dexamethasone failed to significantly extend the time to disease progression or death in people with newly diagnosed multiple myeloma who are ineligible for stem cell transplants, compared with Revlimid and dexamethasone alone, results from a Phase 3 trial show.
The combination did help patients live 13.5 months longer without signs of disease worsening than the Revlimid-dexamethasone combo, but the results failed to reach statistical significance, meaning the TOURMALINE-MM2 trial failed its primary goal of progression-free survival.
Additional data will be presented at an upcoming medical meeting, Takeda, which makes Ninlaro, said.
“There is a need for treatment options in transplant-ineligible patients,” Christopher Arendt, head of the oncology therapeutic area unit at Takeda, said in a press release. “We remain committed to advancing the field of multiple myeloma, and continue to drive innovation through ongoing research and development.”
Ninlaro is an oral proteasome inhibitor marketed by Takeda. Proteasome inhibitors block the activity of a cellular complex that breaks down unnecessary or faulty proteins, called proteasome. By interfering with proteasome activity, these therapies are intended to prevent cancer cells from destroying the toxic buildup of proteins, which ultimately kills cancer cells.
Ninlaro is currently approved to be used in combination with Revlimid and dexamethasone in previously treated people with multiple myeloma. But whether the triple combination can also be used as a first-line therapy for myeloma patients unable to receive a stem cell transplant is not yet known.
TOURMALINE-MM2 (NCT01850524) is an international, randomized Phase 3 clinical trial designed to evaluate if a combination of Ninlaro to Revlimid and dexamethasone is better than Revlimid and dexamethasone in newly diagnosed myeloma patients.
The trial included 705 patients who received oral treatment with once-weekly Ninlaro, or a placebo, along with daily oral Revlimid and once-weekly oral dexamethasone.
The primary goal was to determine if Ninlaro extended the time patients lived without signs of disease progressing. Secondary measures included the proportion of patients achieving a complete response, pain and use of analgesics, and overall survival.
Results showed that patients on Ninlaro lived without disease progression for a median of 35.3 months, compared with 21.8 months for those receiving a placebo. This 17% reduction in the risk of disease progression or death, however, did not reach statistical significance.
The safety profile associated with addition of Ninlaro was consistent with existing information.
Researchers are now examining the full data from TOURMALINE-MM2, and the findings “will be submitted to an upcoming medical congress,” Takeda said.
“We are confident there will be numerous learnings from this trial, and look forward to sharing these data with the community,” Arendt said.
Study investigators have been informed of the results and will discuss the impact of the data with study participants. For individuals who are currently part of the study, it is up to the discretion of doctors whether to continue the current treatment, Takeda said.
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