Daratumumab Combo Improves PROs for Patients with Newly Diagnosed MM

Compared with lenalidomide (Revlimid) and dexamethasone (Rd) alone, the combination with the addition of daratumumab (Darzalex) (D-Rd) for the treatment of transplant-ineligible, newly diagnosed multiple myeloma was associated with improved patient-reported outcomes (PROs), according to data published in the Journal of Clinical Oncology.

The combination resulted in faster and clinically meaningful improvements in PROs, specifically relating to pain, regardless of depth of treatment response or a patient’s age and baseline ECOG status in the phase III MAIA study (NCT02252172).

“These [health-related quality of life (HRQOL)] improvements were consistent with the clinical benefits of superior [progression-free survival] and deep and durable responses observed with D-Rd and further emphasize the utility of PROs as an adjunct to clinical efficacy in the management of [multiple myeloma],” wrote the investigators, who were led by Aurore Perrot, MD, PhD. “As the treatment landscape evolves for patients with [newly diagnosed multiple myeloma], the goals of first-line therapy should include improvement or maintenance of HRQOL reflecting clinical efficacy.”

The team of investigators used the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (QLQ-C30) and the EuroQol 5-dimensional descriptive system (EQ-5D-5L) to assess PROs for the cohort of transplant-ineligible patients (n = 737). The patients were randomly assigned to D-Rd (n = 368) or Rd (n = 369).

Global health status scores from the QLQ-C30 not only improved from baseline in both cohorts, but scores were consistently greater for the D-Rd group at all time points. With D-Rd, a global health status benefit was achieved regardless of a number of factors including age, baseline ECOG performance status score, and depth of response.

Starting in cycle 3 and sustaining through cycle 12, treatment with D-Rd compared to Rd saw a significantly greater reduction in pain scores for patients versus Rd alone (P = .0007). Similar to the global health status benefit, the pain reductions were clinically significant regardless of age, ECOG status, or depth of response.

“PROs are important to understand patients’ perspectives in chronic diseases such as [multiple myeloma] and may be useful to engage patients and providers in treatment decision making,” wrote the investigators. “[Transplant-ineligible] patients with [newly diagnosed multiple myeloma] from the MAIA trial showed early and substantial PRO improvements from baseline during treatment with D-Rd compared with Rd alone.”

PRO improvements were also observed in both treatment groups on the EQ-5D-5L visual analog scale score.

For both groups, compliance with PRO assessments was high both at baseline (>90%) and at month 12 (>78%).

While the data were significant, the investigators acknowledge their study has a number of limitations. PROs were a secondary end point of their data; thus, they were not powered to detect differences between each group. Moreover, these PROs were limited to patients who were undergoing treatment and therefore did not account for disease progression occurring in the Rd group.

“Compared with Rd, D-Rd was associated with faster and sustained clinically meaningful improvements in [global health status] and pain in [transplant-ineligible] patients with [newly diagnosed multiple myeloma] regardless of age, baseline ECOG PS, or depth of treatment response,” wrote the investigators.

Reference:

Perrot A, Facon T, Plesner T, et al. Health-related quality of life in transplant-ineligible patients with newly diagnosed multiple myeloma: findings from the phase III MAIA trial. J Clin Oncol. 2020;39(3):227-237.doi:10.1200/JCO.20.01370