Preliminary Results from a Phase I Study of Isatuximab in Combination with Bortezomib, Lenalidomide, Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma Non-Eligible for Transplant
Isatuximab (ISA) is an anti-CD38 monoclonal antibody with multiple modes of action for killing tumor cells via direct tumor targeting and immune cell engagement. ISA, combined with bortezomib, has demonstrated strong potentiation in a multiple myeloma (MM) xenograft model (Clin Cancer Res 2014:20:4754). This supported evaluation of ISA with bortezomib combinations in pts with newly diagnosed multiple myeloma (NDMM) ineligible for transplant. In the initial cohort, ISA combined with bortezomib, cyclophosphamide, and dexamethasone (dex) was well tolerated with 73% of pts achieving very good partial response (VGPR) or better and 40% with complete response (CR) (Blood 2017; 130: 3160). The combination of bortezomib, lenalidomide, and dex (VRd) is also effective in NDMM (Lancet 2017:389:519–27). Here, we report initial data from a Phase Ib study of ISA plus VRd in pts with NDMM (NCT02513186).
These data suggest that ISA plus VRd followed by ISA plus Rd is well tolerated with a high ORR of 93%. All responders had VGPR or CR except 1 pt with PR. Quality of CR may have been underestimated due to ISA interference which could be resolved with an interference assay.
Enrique M. Ocio, MD, Paula Rodriguez Otero, Sara Bringhen, MD, Stefania Oliva, Axel Nogai, MD, Michel Attal, MD, PhD, Philippe Moreau, Dheepak Kanagavel, Thomas Fitzmaurice, PhD, Junlong Wu and Joaquin Martinez-Lopez, MD, PhD
ASH 2018 Abstract 595 "Preliminary Results from a Phase I Study of Isatuximab (ISA) in Combination with Bortezomib, Lenalidomide, Dexamethasone (VRd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Non-Eligible for Transplant"
ABOUT ENRIQUE M. OCIO, MD
Dr. Enrique M. Ocio is the Head of the Hematology Department at the Hospital Universitario Marqués de Valdecilla, Universidad de Cantabria, Spain. His fields of expertise are clinical trials, new drugs development and, particularly, multiple myeloma.