Clinical Trials

Date: 2014-10-01

Type of information: Initiation of the trial

phase: 1

Announcement: initiation of the trial

Company: BMS (USA - NY) Innate Pharma (France)

Product: lirilumab (BMS-986015) and elotuzumab (BMS-901608)

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 is licensed to Bristol-Myers Squibb Company. As part of the agreement between Innate Pharma and Bristol-Myers Squibb, Bristol-Myers Squibb holds exclusive worldwide rights to develop, manufacture and commercialize lirilumab and related compounds blocking KIR receptors, for all indications. Under the agreement, Innate Pharma conducts the development of lirilumab through Phase II in AML.
  • 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 Bristol-Myers Squibb 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.

Disease: multiple myeloma

Therapeutic area: Cancer - Oncology


Trial details:

  • The purpose of this Phase I open label study is to investigate elotuzumab in combination with lirilumab in order to determine whether this combined treatment approach is safe and to provide preliminary information on the clinical activity of the combination. A second arm will test the combination of elotuzumab and the anti-CD137 antibody urelumab. The primary outcome will be safety. Secondary outcomes will include a preliminary assessment of efficacy. The study will be conducted in two parts - dose escalation and randomized cohort expansion - and is expected to enroll up to approximately 68 patients per arm. Patients should have multiple myeloma with measurable disease (according to the IMWG criteria). (NCT02252263)

Latest news:

  • • On October 1, 2014, Innate Pharma, the innate immunity company developing first-in-class therapeutic antibodies for cancer and inflammatory diseases, announced that a new Phase I combination trial with lirilumab, a first-in-class NK cell checkpoint inhibitor, was published on \"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\" (study identifier: NCT02252263). Lirilumab is licensed to BMS and this Phase I trial is being conducted by BMS

Is general: Yes