Daratumumab Combination: New Standard of Care in Transplant-Ineligible Multiple Myeloma
The findings may support the triplet regimen as a new standard of care for these patients, according to Dr Facon.
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Adding daratumumab to standard treatment with lenalidomide and dexamethasone (DRd) reduced the risk of progression or death by 44% among patients with transplant-ineligible newly diagnosed multiple myeloma, according to an interim analysis of data from the randomized, open-label, multicenter phase 3 MAIA clinical trial (ClinicalTrials.gov Identifier: NCT02252172). The interim findings were presented at the 2018 American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, California.1
“These results support DRd as a new standard of care for patients with transplant-ineligible newly diagnosed multiple myeloma,” said lead study author Thierry Facon, MD, of the Service des Maladies du Sang, Hôpital Claude Huriez, in Lille, France. “DRd induced significantly deeper responses, including more than a 3-fold higher minimal residual disease [MRD]-negative rate.”
“Certainly, deeper remissions are a very exciting prospect,” commented Mark Crowther, MD, MSc, FRCPC, of McMaster University in Hamilton, Ontario, Canada. Dr Crowther was not involved in the study. “I think with time, longer follow-up data will be especially helpful in determining if it induces long-term benefits.”
No new safety signals were observed, Dr Facon reported.
“This regimen is relatively gentle for elderly and very elderly patients but we still have to see the [currently immature] overall survival data,” he said.
Rd and bortezomib, lenalidomide, and dexamethasone (VRd) are considered standards of care for these patients. Previous research (the POLLUX study) found a 63% reduction in disease progression or death among patients receiving DRd for relapsed/refractory multiple myeloma.
The phase 3 MAIA study assessed DRd versus Rd in patients with transplant-ineligible, newly diagnosed multiple myeloma. A total of 737 patients with ECOG performance scores of 0 to 2 and creatinine clearance of at least 30 mL/minute were enrolled in the study and randomly assigned to receive Rd either with (DRd, 368 patients) or without (Rd, 369 patients) daratumumab on a 28-day cycle. Patient demographics were well balanced between the 2 study groups.
Median progression-free survival (PFS) was 31.9 months for Rd-group patients and was not yet reached in DRd patients. The estimated 30-month PFS was 71% for DRd-group patients versus 56% for Rd patients — a 44% reduction in the risk of progression or death among patients receiving daratumumab (hazard ratio [HR] 0.56; 95% CI: 0.43-0.73; P < 0.0001), Dr Facon reported.
“The PFS benefit was observed across prespecified subgroups, including age, renal function, and ECOG function,” he noted.