Date: 2015-11-12
Type of
information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: BMS (USA - NY)
Product: lirilumab and nivolumab alone or in combination with azacitidine
Action
mechanism:
- monoclonal antibody/immune checkpoint inhibitor/antineoplastic agent/nucleosid analog. 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.
- Nivolumab is an investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. PD-1, a receptor expressed on the surface of lymphocytes, plays a role in a regulatory pathway that suppresses activated lymphocytes in the body. Available evidence suggests that cancer cells exploit this pathway to escape from immune responses. Opdivo® is thought to provide benefit by blocking PD-1-mediated negative regulation of lymphocytes (i.e., the interaction of PD-1 with its ligands PD-L1 and PD-L2), thereby enhancing the ability of the immune system to recognize cancer cells as foreign and eliminate them. Opdivo® is the world’s first approved drug targeting PD-1.
- This monoclonal antibody has been generated under a research collaboration entered into in May 2005 between Ono and Medarex. When Medarex was acquired by BMS in 2009, it also granted BMS its rights to develop and commercialize the anti-human PD-1 monoclonal antibody in North America. Through the collaboration agreement entered into in September 2011 between Ono and BMS, Ono granted BMS exclusive rights to develop and commercialize Opdivo® in the rest of the world, except in Japan, Korea and Taiwan where Ono has retained all rights to develop and commercialize the compound.
Disease: myelodysplastic syndrome (MDS)
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- The goal of this clinical research study is to learn if lirilumab and Opdivo® (nivolumab), alone or in combination with Vidaza® (azacitidine), can help to control MDS. The safety of these drug combinations will also be studied. (NCT02599649)
Latest
news:
- • On November 12, 2015, Innate Pharma announced that a new trial performed by the MD Anderson cancer center started, testing a combination of nivolumab, lirilumab and 5-azacytidine for the treatment of patients with myelodysplastic syndrome.
This is the third trial with lirilumab supported by BMS and performed by the MD Anderson cancer center in 2015, after the opening of one trial testing the combination of lirilumab and 5-azacytidine in relapsed/ refractory AML and another trial testing the combination of lirilumab and rituximab in relapsed/ refractory or high-risk untreated CLL.
These new trials bring to 8 the number of trials performed with lirilumab, testing a broad range of solid and hematological cancer indications, multiple rationales and combinations with cytotoxic antibodies, checkpoint inhibitors and chemotherapy.
Is
general: Yes
