In Relapsed or Refractory Myeloma, Addition of Elotuzumab to Lenalidomide + Dexamethasone Improves Outcomes with No Detriment to Quality of Life

Conference Correspondent 

After a minimum follow-up of 71 months, the efficacy benefits observed with the addition of elotuzumab to lenalidomide/dexamethasone (Ld) in patients with relapsed or refractory multiple myeloma (MM) were achieved without negatively affecting health-related quality of life (HRQoL) compared with lenalidomide/dexamethasone alone. These findings come from a final analysis of patient-reported outcomes (PROs) from the phase 3 ELOQUENT-2 trial, reported by David Cella, PhD, from Northwestern University in Chicago. The investigators observed minimal differences in HRQoL between treatment arms, consistent with the initial analysis.

As a number of novel therapies have now led to durable response rates and prolonged survival in this patient population, assessment of HRQoL has become increasingly important, particularly in patients who have received numerous lines of therapy.

In the trial, 646 patients were randomized 1:1 to either elotuzumab and lenalidomide/dexamethasone (ELd; n = 321) or lenalidomide/dexamethasone alone (n = 325), and 319 and 311 patients had ≥1 post-baseline assessments and were included in the PRO analysis, respectively. The Brief Pain Inventory–Short Form (BPI-SF), the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life–Core 30 questionnaire (QLQ-C30), and the myeloma-specific module (QLQ-MY20) were administered at baseline, on day 1 of each treatment cycle, and at the end of treatment or study withdrawal.

BPI-SF scores range from 0 to 10, with lower scores representing better pain outcomes; EORTC QLQ-C30 scores range from 0 to 100, with higher scores representing better physical functioning and global health status/QoL, and worse fatigue and pain; EORTC QLQ-MY20 scores range from 0 to 100, with higher scores representing worse symptoms and treatment side effects.

After a median follow-up of 24.5 months in the ELOQUENT-2 study, ELd demonstrated a 30% reduction in the risk of progression or death versus lenalidomide/dexamethasone in patients with relapsed or refractory MM and 1 to 3 prior lines of treatment. After a 3-year extended follow-up, PROs showed that the improvement in efficacy observed with the triplet was achieved without a detriment to HRQoL.

In the final overall survival analysis of the study, at a minimum follow-up of 71 months, median overall survival was 48.3 months with the addition of elotuzumab versus 39.6 months with lenalidomide/dexamethasone alone, representing an 18% reduction in the risk of death with ELd versus lenalidomide/dexamethasone.

Baseline BPI-SF mean scores for patients who received elotuzumab were lower across all domains: pain severity (2.6 vs 2.9), pain interference (2.5 vs 2.8), and worst pain (3.6 vs 3.8), and these scores remained stable throughout the course of the study, but in both treatment arms, no clinically meaningful changes in BPI-SF, EORTC QLQ-C30, or QLQ-MY20 mean scores from baseline were observed across all domains of interest.

However, elotuzumab-treated patients who started with moderate or severe pain (score of ≥5) had significantly lower mean pain severity scores versus lenalidomide/dexamethasone-treated patients in treatment cycles 1 through 5. Similar results were observed for pain interference and worst pain domains.

A higher proportion of patients deemed to be clinical responders (based on complete or partial responses according to the European Group for Blood and Marrow Transplantation criteria) had sustained reductions in pain scores across all BPI-SF domains when compared with nonresponders: pain severity (18% vs 6%), pain interference (15% vs 6%), and worst pain (30% vs 13%), but there was no statistically significant difference in time to sustained score reduction for any BPI-SF domains between clinical responders and nonresponders.

“These findings complement results from the final OS analysis of ELOQUENT-2, which demonstrate a statistically significant and clinically meaningful improvement in OS with ELd versus Ld alone,” reported Dr Cella.


Cella D. ASH Abstract 2190.

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