Additional Relevant Details 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 tumors. Enrollment is scheduled to begin in late 2016, and Boehringer Ingelheim will be the sponsor of the study program.


Lilly's abemaciclib is designed to block the growth of cancer cells by specifically inhibiting CDK 4 and CDK 6. In many cancers, uncontrolled cell growth arises from a loss of control in regulating the cell cycle due to increased signaling from CDK 4 and CDK 6. Boehringer Ingelheim's BI 836845 is an IGF ligand-neutralizing antibody that binds to both IGF-1 and IGF-2 preventing activation of the respective receptor resulting in decreased growth-promoting signaling, which may decrease tumor growth. In a Phase 1b/2 trial BI 836845 has shown promising preliminary efficacy and good clinical safety in combination with everolimus and exemestane in patients with HR+ mBC.1The 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.