Date: 2016-07-13
Type of information: Clinical research agreement
Compound: BI 836845 and abemaciclib (LY2835219)
Company: Boehringer Ingelheim (Germany) Eli Lilly (USA - IN)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: monoclonal antibody. BI 836845 is a humanised antibody that binds to insulin-like growth factor (IGF) signalling pathways, which may play a role in the development or spread of cancer by providing a growth mechanism for tumours. BI 836845 specifically binds to IGF-1 and IGF-2. It is being studied in combination with other agents for use in patients with advanced solid tumours. cell cycle inhibitor/cyclin dependant kinase inhibitor. Abemaciclib (LY2835219) is a cell cycle inhibitor, designed to block the growth of cancer cells by specifically inhibiting CDK 4 and 6. Although abemaciclib inhibits both CDK 4 and CDK 6, the results from the cell-free enzymatic assays have shown that it was most active against Cyclin D 1 and CDK 4.
Disease: hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (mBC)
Details: * On July 13, 2016, Boehringer Ingelheim and Eli Lillyannounced a new collaboration on a Phase 1b study that will evaluate the safety and tolerability of BI 836845, Boehringer Ingelheim’s insulin-like growth factor (IGF)-1/IGF-2 ligand neutralising antibody, in combination with abemaciclib (LY2835219), Lilly’s cyclin-dependent kinase (CDK) 4 and 6 inhibitor, in patients diagnosed with HR+/HER2- mBC. Based on the Phase 1b trial results, the collaboration has the potential to expand to Phase 2 trials in patients with HR+/HER2- mBC and other solid tumours. Enrolment is scheduled to begin in late 2016 and Boehringer Ingelheim will be the sponsor of the study programme. The rationale for the collaboration is based upon the hypothesis that these two agents, in combination, could offer a more complete pathway interference and could potentially prolong cell cycle arrest. For HR+/HER2- mBC patients, this could translate to a reversal of resistance to hormone therapy.
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