Ixazomib Combo With Pomalidomide, Dexamethasone Increases PFS in Patients With R/R MM

Results from an Alliance for Clinical Trials in Oncology phase 1/2 study in patients with relapsed/refractory (R/R) multiple myeloma (MM) who received frontline lenalidomide therapy showed that adding ixazomib to pomalidomide and dexamethasone as part of a second line therapy increased progression-free survival (PFS) compared with patients who received only pomalidomide and dexamethasone.

The primary objective of the phase 1 study was to establish the maximum tolerated dose for the combination therapy of pomalidomide, dexamethasone, and ixazomib. The primary objective of the phase 2 was to assess whether the combination of pomalidomide, dexamethasone, and ixazomib improves PFS compared with pomalidomide and dexamethasone.

Patients received increasing doses of pomalidomide, dexamethasone, and ixazomib over a 28-day cycle in phase 1, and were treated until their disease progressed or the patients experience toxicities. Patients enrolled in phase 2 were required to have proteasome inhibitor naïve or sensitive disease that had progressed on lenalidomide as part of frontline treatment for MM.

Results determined that adding ixazomib to pomalidomide and dexamethasone as part of a second line therapy increases PFS.

As a result of the data obtained from Alliance A061203, the Data and Safety Monitoring Board recommends that patients who are currently receiving pomalidomide, dexamethasone, and ixazomib continue their therapy, but any patient receiving pomalidomide and dexamethasone can choose to add ixazomib to their current regimen or at the time of disease progression.

“We found that pomalidomide, ixazomib, and dexamethasone can be combined safely,” said Peter Voorhees, MD, Levine Cancer Institute, Atrium Health, Charlotte, North Carolina. “The preliminary efficacy of this combination is promising and warrants additional investigation in phase III trials. Our results provide support for the use of this all-oral regimen for patients with lenalidomide-refractory multiple myeloma in need of second line therapy, a growing patient population that has not been evaluated well in randomized studies to date.”

Alliance for Clinical Trials in Oncology. Alliance for Clinical Trials in Oncology Phase I/II Study Shows Increased Progression-Free Survival for Patients With Relapsed/Refractory Multiple Myeloma Who Received Ixazomib (Ninlaro®) in Combination With Pomalidomide and Dexamethasone. Accessed January 19, 2022. https://www.allianceforclinicaltrialsinoncology.org/main/public/standard.xhtml?path=/Public/News-A061202-Dec2021