Date: 2016-07-25
Type of information: Clinical research agreement
Compound: Rova-T (rovalpituzumab tesirine) in combination with Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab)
Company: Abbvie (USA - IL) BMS (USA - NY)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: monoclonal antibody/immune checkpoint inhibitor/antibody drug conjugate. Rova-T (rovalpituzumab tesirine) is an antibody drug conjugate (ADC) targeting delta-like protein 3 (DLL3). This protein is present at high levels in small cell lung cancer and other neuroendocrine tumor cells. 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. Cytotoxic T-lymphocyte antigen-4 (CTLA-4) is a negative regulator of T-cell activation. ipilimumab binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation. The mechanism of action of ipilimumab’s effect in patients with melanoma is indirect, possibly through T-cell mediated anti-tumor immune responses.
Disease: relapsed extensive-stage small cell lung cancer (SCLC)
Details: * On July 25, 2016, AbbVie and BMS announced a clinical trial collaboration to evaluate the safety, tolerability and efficacy of AbbVie’s investigational biomarker-specific antibody drug conjugate Rova-T (rovalpituzumab tesirine) in combination with BMS' Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen as a treatment for relapsed extensive-stage small cell lung cancer (SCLC). The Phase 1/2 clinical program will explore the potential of combining BMS' immuno-oncology agents, which are designed to alleviate immune suppression, in conjunction with AbbVie’s investigational antibody drug conjugate, Rova-T, to drive improved and sustained efficacy and tolerability above the current standard of care. This collaboration will determine if the targeted cell killing and antigen release caused by Rova-T may further enhance the effect of immunotherapy.
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