Results from the TOURMALINE-MM3 study, a randomized, placebo-controlled, multicenter, multinational, phase 3 clinical trial investigating ixazomib (NINLARO) as a maintenance therapy for adult patients with multiple myeloma who previously responded to high-dose therapy (HDT) and autologous stem cell transplant (ASCT), were presented at the 60th ASH Annual Meeting & Exposition
in San Diego, California.
Among the highlights observed in the data, the single-agent oral demonstrated significant improvement in progression-free survival (PFS).
“The big challenge in treating multiple myeloma is that it is an incurable disease,” investigator Katja Weisel, MD, associate professor at the University Hospital of Tübingen, told Rare Disease Report®
. “For the patient, it’s very important that we delay and avoid relapses because any relapse results in an impairment of life quality and results in more pain and renal impairment.”
“Delaying relapsing disease is crucial for the patient, and especially that [the treatment] is well tolerated,” she added. “It’s all about tolerance with continuous treatment.”
Achieving the study’s primary endpoint, ixazomib treatment showed PFS in adult patients who were diagnosed with multiple myeloma who responded to HDT and ASCT as assessed by an Independent Review Committee (IRC) (HR .72; p-value=.002). Specifically, observed data translated into a 28% reduction in risk of progression or death and a 39% improvement in PFS compared with placebo.
Ixazomib also demonstrated a favorable safety profile, with only 7% of patients who were administered ixazomib discontinuing treatment due to adverse events (AE). Forty-two percent of patients administered ixazomib experienced Grade ≥3 AEs, and 27% experienced serious AEs. Nineteen percent of patients administered ixazomib experienced peripheral neuropathy, with <1 percent of peripheral neuropathy events being Grade 3.
Infections, pneumonia, gastrointestinal disorders, neutropenia, and thrombocytopenia were common grade ≥3 AEs observed in patients administered both ixazomib and placebo.
“In the trial, we saw ixazomib was really well tolerated,” Dr. Weisel said. “We, as investigators, were not able to say which patient received placebo and which one received ixazomib, which shows how well tolerated it was. This was a surprise for all of us—that it was possible to do a true placebo-controlled trial.”
Dr. Weisel also discussed the positive impact on the quality of life ixazomib had on patients as it did not impair the life quality of patients in treatment.
“I think we will receive an alternative for maintenance treatment [with ixazomib],” she said. “Currently, the standard of care is lenalidomide treatment; this is the only approved maintenance in first-line after stem cell transplantation.”
Look forward, Dr. Weisel expressed her excitement for the potential of ixazomib in combination with other drugs. “With the upcoming data, ixazomib gives us the chance to combine well-tolerated drugs. We have an alternative and upcoming—probably—combination treatment strategy to the needs of patients.”