A sequential cohort study evaluating single‐agent KappaMab and KappaMab combined with lenalidomide and low‐dose dexamethasone in relapsed and/or refractory kappa light chain‐restricted multiple myeloma (AMaRC 01‐16)

Author:

Spencer Andrew1ORCID,Kalff Anna1ORCID,Shortt Jake23,Quach Hang45ORCID,Wallington‐Gates Craig67,Reynolds John1,Walker Patricia18,Harrison Simon J.910ORCID,Dunn Rosanne11,Wellard Cameron12

Affiliation:

1. Department of Clinical Haematology Alfred Health‐Monash University Melbourne Victoria Australia

2. Department of Haematology Monash Health Clayton Victoria Australia

3. Department of Medicine School of Clinical Sciences, Monash University Clayton Victoria Australia

4. Department of Haematology St Vincent's Hospital Melbourne Victoria Australia

5. Faculty of Medicine University of Melbourne Melbourne Victoria Australia

6. College of Medicine and Public Health Flinders University Bedford Park South Australia Australia

7. Flinders Medical Centre Southern Adelaide Local Health Network Bedford Park South Australia Australia

8. Peninsula Health Frankston Victoria Australia

9. Clinical Haematology Peter MacCallum Cancer Centre Melbourne Victoria Australia

10. Sir Peter MacCallum Department of Oncology Royal Melbourne Hospital Melbourne Victoria Australia

11. HaemaLogiX Ltd Wooloomooloo New South Wales Australia

12. Transfusion Research Unit, School of Public Health and Preventative Medicine Monash University Melbourne Victoria Australia

Abstract

SummaryKappaMab (KM; formerly MDX‐1097) is a monoclonal antibody specific for the kappa myeloma antigen (KMA), a cell‐surface antigen expressed on malignant plasma cells in kappa‐restricted multiple myeloma (κMM), some lymphomas, occasional tonsillar B cells and in vitro activated B cells, but not on normal B cells in bone marrow. Phase I/IIa studies of single‐agent KM confirmed a favourable toxicity profile and evidence of anti‐myeloma activity. Ex‐vivo studies demonstrating upregulation of KMA by lenalidomide, and enhanced effector‐cell cytotoxicity provided the rationale for this phase IIb study where KM or KM in combination with lenalidomide and dexamethasone (KM‐Rd) was administered in relapsed, refractory κMM patients. In addition, outcomes for a real‐world matched case–control cohort from the Australian and New Zealand Myeloma and Related Diseases Registry (MRDR) who received Rd were compared to the KM‐Rd cohort. KM‐Rd demonstrated an overall response rate of 82.5% which compared favourably to the Rd‐MRDR cohort of 45.1%. Both single‐agent KM and KM‐Rd regimens were well tolerated, with the KM‐Rd safety profile similar to patients given only Rd in other clinical settings. Based on the excellent safety profile and significant efficacy, further clinical trials escalating the KM dose and pairing KM with other standard‐of‐care treatments are planned.

Funder

Celgene

Victorian Cancer Agency

Publisher

Wiley

Subject

Hematology

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