Daratumumab Plus Lenalidomide/Dexamethasone Combination Demonstrated Survival Benefit for Newly Diagnosed Multiple Myeloma

The combination of daratumumab (Darzalex) plus lenalidomide (Revlimid) and dexamethasone demonstrated a significant overall survival (OS) benefit compared with lenalidomide and dexamethasone alone for patients with newly diagnosed multiple myeloma, according to a presentation of the phase 3 MAIA study (NCT02252172) at the 18th International Myeloma Workshop.

The study focused on updated efficacy and safety data of daratumumab plus lenalidomide and dexamethasone compared with lenalidomide and dexamethasone after nearly 5 years of median follow-up.

“Those results, when looking at [daratumumab plus lenalidomide and dexamethasone], both for PFS and OS and a relatively good safety profile, I would say, are now establishing [daratumumab plus lenalidomide and dexamethasone] as a new standard of care for patients that are not transplant eligible,” said Philippe Moreau, MD, professor of clinical hematology at University Hospital Hôtel-Dieu, in a presentation of the findings.

In particular, researchers analyzed data from 737 patients with newly diagnosed multiple myeloma. These patients were ineligible for high-dose chemotherapy and autologous stem cell transplantation because of their age (older than 65 years) or the presence of comorbidities. Patients were randomly assigned daratumumab plus lenalidomide and dexamethasone (n = 368) or lenalidomide and dexamethasone (n = 369). Patients had a median age of 73 years (range, 45-90).

“One very important point and theory … for elderly patients, we know that many of them are not able to receive 2 or 3 lines of treatment, so this suggests that the most effective treatment should be used upfront and not saved for relapse,” Moreau said.

The primary endpoint was progression-free survival, with key secondary endpoints including overall survival, among others.

After a median follow-up of 56.2 months, patients assigned daratumumab plus lenalidomide and dexamethasone had a 32% reduction in the risk for death compared with those assigned lenalidomide and dexamethasone.

The median overall survival was not reached in either group (HR = 0.68; 95% CI, 0.53-0.86; P = .0013). Estimated overall survival at 5 years was 66.3% in the daratumumab plus lenalidomide and dexamethasone group compared with 53.1% in the lenalidomide and dexamethasone group.

The updated median progression-free survival was not reached in patients assigned daratumumab plus lenalidomide and dexamethasone, whereas patients assigned lenalidomide and dexamethasone had a median progression-free survival of 34.4 months (HR = 0.53; 95% CI, 0.43-0.66; P = .248).

Longer follow-up did not result in new safety concerns. The most common grade 3/4 treatment-emergent adverse event was neutropenia, occurring in 54.1% of patients in the daratumumab plus lenalidomide and dexamethasone group and 37% in the lenalidomide and dexamethasone group.

Reference

Moreau P, Facon T, et al. Overall Survival and Progression-free Survival by Treatment Duration With Datatumumab + Lenalidomide/Dexamethasone in Transplant-ineligible Newly Diagnosed Multiple Myeloma: Phase 3 MAIA Study. Presented at: 18th International Myeloma Workshop; September 8-11, 2021; Vienna, Austria. Oral Abstract Session.