An evaluation of subcutaneous daratumumab for the treatment of multiple myeloma

ABSTRACT

Introduction

A subcutaneous formulation of daratumumab, a human immunoglobulin G1 kappa monoclonal antibody targeting CD38, recently achieved FDA approval for both newly diagnosed and relapsed refractory multiple myeloma amid promises to decrease infusion times and rates of infusion reactions in myeloma patients.

Areas covered

In this article the biology behind subcutaneous administration of oncologic antibody therapies is reviewed and the subcutaneous formulation of daratumumab is covered in depth. The most recent results from the PAVO, COLUMBA, and PLEIADES clinical trials evaluating subcutaneous daratumumab as a single agent, and in combination, in both newly diagnosed, and relapsed and refractory myeloma patients are summarized. The efficacy, safety, and PK data from these trials are reviewed, and the potential of the subcutaneous formulation to improve quality of life in myeloma patients and decrease healthcare resource use is discussed.

Expert opinion

Subcutaneous daratumumab is non-inferior to conventional intravenous daratumumab with lower risk of infusion-related reactions and decreased administration time. Based on these data, and the recent FDA and European Commission approvalsthe widespread use of the subcutaneous formulation for both conventional and investigational practice is supported.

KEYWORDS:

• Daratumumab
• multiple myeloma
• subcutaneous
• relapsed
• refractory

Declaration of interest

SZ Usmani has received Research funding from: the Carolinas Myeloma Research Fund, Britton Family Fund, Heinemann Foundation of Charlotte and the Leukemia Lymphoma Society. Amgen, Array Biopharma, BMS, Celgene, GSK, Janssen, Merck, Pharmacyclics, Sanofi, Seattle Genetics, SkylineDX, Takeda; Consulting Fees from Amgen, BMS, Celgene, GSK, Janssen, Merck, Sanofi, SkylineDx, Takeda and Speaking Fee from Amgen, Celgene, Janssen, Takeda. S Atrash has received consulting honorarium from Takeda, Amgen, Karyopharm, BMS, Sanofi, Cellactar, Janssen and Celgene and is a speaker bureau for Celgene, Janssen, and Sanofi. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.