Lilly and Boehringer Ingelheim take on metastatic breast cancer

Lilly and Boehringer Ingelheim are to collaborate on a Phase Ib study of Lilly’s abemaciclib and Boehringer Ingelheim’s BI 836845 in patients with HR+, HER2- metastatic breast cancer.

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 signalling from CDK 4 and CDK 6. Boehringer Ingelheim’s BI 836845 is an IGF ligand-neutralising antibody that binds to both IGF-1 and IGF-2 preventing activation of the respective receptor resulting in decreased growth-promoting signalling, which may decrease tumour growth. In a Phase Ib/II trial BI 836845 has shown promising preliminary efficacy and good clinical safety in combination with everolimus and exemestane in patients with HR+ metastatic breast cancer.

The rationale for the collaboration announced today 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- metastatic breast cancer patients, this could translate to a reversal of resistance to hormone therapy.

Enrolment to begin later this year

If the results of the Phase Ib trial are encouraging, the companies may expand to Phase II trials in patients with HR+, HER2- metastatic breast cancer and other solid tumours. Enrolment for the Phase Ib trial will begin later this year.

Commenting on the collaboration, Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology, said: “We are pleased to join with Boehringer Ingelheim to study the potential of their molecule in combination with Lilly’s abemaciclib, for which we have an active Phase III development programme underway. For patients living with metastatic breast cancer, the limited treatment options available make this an important area of focus for our efforts to advance the most innovative treatments.”

Dr Mehdi Shahidi, medical head, solid tumor oncology, Boehringer Ingelheim added, “Boehringer Ingelheim is excited about initiating this collaboration with Lilly to investigate a novel combination of two compounds that have individually shown promising results in metastatic breast cancer and have a complementary mode of action. We hope that this study will lay foundations for making much needed new therapies available to patients with metastatic breast cancer.”