Among patients with newly diagnosed, transplant-ineligible patients with multiple myeloma (MM), adding daratumumab to lenalidomide and dexamethasone (D-Rd) appears to improve long-term outcomes, according to research presented at the 19th Annual Meeting and Exposition International Myeloma Society.

Data from the randomized phase 3 MAIA trial (ClinicalTrials.gov Identifier: NCT02252172) previously suggested that, compared with Rd, D-Rd improves both progression-free survival (PFS) and overall survival (OS) among patients with transplant-ineligible, newly diagnosed MM. Given, however, that D-Rd is associated with a high cost in the long term, researchers aimed to determine the long-term safety and efficacy of D-Rd in this patient population.

For this study, researchers conducted a post-hoc analysis of OS data based on whether patients received D-Rd for at least 18 months. A PFS analysis also evaluated data from patients who received D-Rd or Rd alone for at least 9 months.


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The median follow-up was 56.2 months; the intent-to-treat population included 368 patients. At this point, patients with MM who received D-Rd for at least 18 months had a hazard ratio [HR] for OS of 0.16 (95% CI: 0.1-0.25; P <.0001) compared with patients who received D-Rd for less than 18 months.

Compared with Rd alone, researchers noted clinical benefits with D-Rd both among patients who received treatment for at least 18 months (HR for PFS, 0.57; P <.0001; HR for OS, 0.68; P =.0379) and 9 months (HR for PFS, 0.49; P <.0001; HR for OS, 0.63; P =.0025).

Furthermore, among 48 patients who discontinued R with or without d, but who continued D with or without d, the 60-month PFS and OS rates were 97.9% and 100%, respectively; this contrasted with 60-month PFS and OS rates of 52.5% and 66.3% in the overall study population.

Analysis also suggested that patients treated for at least 18 months had higher complete response or better rates (49.8% at 18 months compared with 9.2% at 6 months). The authors noted that no previously unknown safety signals were observed; the rate of grade 3-4 adverse events also appeared to decrease over time with D-Rd.

“Our findings support D-Rd treatment for at least 18 months to achieve deep clinical responses and that stopping D-Rd earlier based on response level may compromise long-term patient outcomes,” the authors stated in their presentation.

Disclosure: The study author(s) declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Moreau P, Facon T, Usmani S, et al. Treatment duration and long-term outcomes with daratumumab in transplant-ineligible newly diagnosed multiple myeloma from the phase 3 MAIA study. Presented at IMS 2022; August 25-27, 2022. Abstract OAB-039.

This article originally appeared on Hematology Advisor