TOURMALINE-MM1: Overall Survival Outcomes With All-Oral Regimen
Posted: Tuesday, August 3, 2021
The phase III TOURMALINE-MM1 trial found that the all-oral combination proteasome inhibitor therapy of ixazomib/lenalidomide/dexamethasone (ixazomib-Rd), compared with placebo, was associated with improved progression-free survival in patients with resistant multiple myeloma. However, Philippe Moreau, MD, of University Hospital Hôtel Dieu, Nantes, France, and international colleagues found that this increase in progression-free survival did not seem to translate to an increase in overall survival for this patient population. However, an overall survival benefit was reported to be greater in subgroups of patients with adverse prognostic factors.
“The impact of the evolving relapsed or refractory multiple myeloma treatment landscape on the ability to demonstrate overall survival benefit in clinical trials warrants further consideration regarding randomized trial design and the utility of overall survival as an endpoint,” the study authors commented. “Nonetheless, with a demonstrated progression-free survival benefit, limited additional toxicity versus placebo-Rd, and the convenience of an all-oral triplet regimen, ixazomib-Rd continues to represent an important treatment option for patients with relapsed or refractory multiple myeloma.” The findings of this study were published in the Journal of Clinical Oncology.
The double-blind, placebo-controlled, multinational TOURMALINE-MM1 study enrolled patients with resistant myeloma who were randomly assigned to receive ixazomib-Rd (n = 360) or placebo-Rd (n = 362). Patients were stratified into groups based upon the number of previous therapies, prior use of a proteasome inhibitor, and disease stage.
At the median follow-up of 85 months, there no significant difference between ixazomib-Rd (53.6 months) and placebo (51.6 months) in terms of overall survival (hazard ratio = .939, P = .495). However, patients who achieved the most benefit in overall survival following ixazomib-Rd were those who were refractory to any or their last treatment line, aged 65 to 75 years, had stage III disease, had received two to three prior therapies, or exhibited high-risk cytogenetics and/or 1q21 amplification. There were no new safety concerns observed following treatment with ixazomib-Rd.
Disclosure: For full disclosures of the study authors, visit ascopubs.org.
