Clinical Trials

Date: 2014-09-26

Type of information: Initiation of the trial

phase: 1

Announcement: initiation of the trial

Company: BMS (USA - NY)

Product: elotuzumab (BMS-901608) in combination with either lirilumab (BMS-986015) or urelumab (BMS-663513)

Action mechanism:

• monoclonal antibody/immune checkpoint inhibitor.
• Lirilumab is a fully human monoclonal antibody (mAb) that blocks the interaction between Killer-cell immunoglobulin-like receptors (KIR) on NK cells and their ligands. Blocking these receptors facilitates activation of NK cells and, potentially, destruction of tumor cells. Lirilumab has been developed by Innate Pharma and licensed to BMS. As part of the agreement, BMS holds exclusive worldwide rights to develop, manufacture and commercialize lirilumab and related compounds blocking KIR receptors, for all indications.
• Elotuzumab is a humanized IgG1 monoclonal antibody targeted against Signaling Lymphocyte Activation Molecule (SLAMF7, also called CS1), a glycoprotein expressed on myeloma and Natural Killer cells but not detectable in normal tissue. BMS is investigating whether through both direct activation and engagement of Natural Killer cells, elotuzumab may selectively target and kill SLAMF7 expressing myeloma cells. Elotuzumab is being studied as a monotherapy in smoldering myeloma and in combination with other therapies in first-line and relapsed or refractory multiple myeloma. A clinical development program for the agent is underway, including Phase 3 trials in first-line multiple myeloma (ELOQUENT-1) and relapsed or refractory multiple myeloma (ELOQUENT-2). Elotuzumab is also being investigated in a randomized Phase 2 study of bortezomib and dexamethasone in relapsed or refractory multiple myeloma. Elotuzumab is being co-developed with AbbVie, with BMS leading the commercialization of the agent. In May 2014, the FDA has granted elotuzumab Breakthrough Therapy Designation for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies.
• Urelumab (BMS-663513) is an agonist of the CD137 co-stimulatory receptor. This monoclonal antibody specifically binds to and activates CD137-expressing immune cells, stimulating an immune response, in particular a cytotoxic T cell response, against tumor cells. CD137 is a member of the tumor necrosis factor (TNF)/nerve growth factor (NGF) family of receptors and is expressed by activated T- and B-lymphocytes and monocytes.

Disease: multiple myeloma

Therapeutic area: Cancer - Oncology

Country: Spain, USA

Trial details:

• The trial is a phase I open label dose escalation and randomized cohort expansion study of the safety and tolerability of elotuzumab (BMS-901608) administered in combination with either lirilumab (BMS-986015) or urelumab (BMS-663513) in subjects with multiple myeloma. (NCT02252263)

           

Latest news:

• The aim of the trial is to assess the safety and tolerability, characterize the dose limiting toxicities (DLTs) and identify the maximally tolerated dose (MTD) of Elotuzumab administered in combination with either Lirilumab or Urelumab in subjects with multiple myeloma. The estimated completion date is April 2017.

Is general: Yes