Elotuzumab, pomalidomide, and dexamethasone is a very well tolerated regimen associated with durable remission even in very advanced myeloma: a retrospective study from two academic centers

Dorothea Hose,Martin Schreder,Maria-Theresa Krauth,Max Bittrich,Stefan Knop,Renate Schoder,Jochen Hefner,Sophia Danhof,Hermann Einsele,Heinz Gisslinger,Susanne Strifler,Bettina Gisslinger

doi:10.1007/s00432-020-03323-6

Dorothea Hose, Martin Schreder + Show 10 more

Open Access

https://doi.org/10.1007/s00432-020-03323-6

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Abstract

BackgroundThe anti-SLAMF7 monoclonal antibody, elotuzumab (elo), plus lenalidomide (len) and dexamethasone (dex) is approved for relapsed/refractory MM in the U.S. and Europe. Recently, a small phase 2 study demonstrated an advantage in progression-free survival (PFS) for elo plus pomalidomide (pom)/dex compared to pom/dex alone and resulted in licensing of this novel triplet combination, but clinical experience is still limited.PurposeTo analyze the efficacy and safety of elo/pom/dex in a “real world” cohort of patients with advanced MM, we queried the databases of the university hospitals of Würzburg and Vienna.FindingsWe identified 22 patients with a median number of five prior lines of therapy who received elo/pom/dex prior to licensing within an early access program. Patients received a median number of 5 four-week treatment cycles. Median PFS was 6.4 months with 12-month and 18-month PFS rates of 35% and 28%, respectively. The overall response rate was 50% and 64% of responding patients who achieved a longer PFS with elo/pom/dex compared to their most recent line of therapy. Objective responses were also seen in five patients who had been pretreated with pomalidomide. Low tumor burden was associated with improved PFS (13.5 months for patients with ISS stage I/II at study entry v 6.4 months for ISS III), although this difference did not reach statistical significance. No infusion-related reactions were reported. The most frequent grade 3/4 adverse events were neutropenia and pneumonia.ConclusionElo/pom/dex is an active and well-tolerated regimen in highly advanced MM even after pretreatment with pomalidomide.

Highlights

Multiple Myeloma (MM) is the second most frequent hematologic malignancy in the U.S and Europe (Rollig et al 2015)
While many patients will receive CD38 antibodybased treatment, immunotherapy directed at alternative antigens are needed
Elotuzumab targets SLAMF7, acts synergistically with IMiDs and was shown to induce durable remissions in relapsed MM with a progression-free survival (PFS) of 19.4 months when combined with len/dex (Lonial et al 2015)

Summary

Introduction

Multiple Myeloma (MM) is the second most frequent hematologic malignancy in the U.S and Europe (Rollig et al 2015). In a randomized phase III trial, the addition of elotuzumab to lenalidomide and low-dose dexamethasone (Rd) resulted in a sustained improvement of progression-free survival (PFS) compared to Rd, leading to approval of the triplet regimen by the FDA and EMA (Lonial et al 2015). The anti-SLAMF7 monoclonal antibody, elotuzumab (elo), plus lenalidomide (len) and dexamethasone (dex) is approved for relapsed/refractory MM in the U.S and Europe. A small phase 2 study demonstrated an advantage in progression-free survival (PFS) for elo plus pomalidomide (pom)/dex compared to pom/dex alone and resulted in licensing of this novel triplet combination, but clinical experience is still limited. The overall response rate was 50% and 64% of responding patients who achieved a longer PFS with elo/pom/dex compared to their most recent line of therapy. Conclusion Elo/pom/dex is an active and well-tolerated regimen in highly advanced MM even after pretreatment with pomalidomide

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