Eli Lilly, Boehringer Ingelheim form clinical trial partnership in metastatic breast cancer

The new collaboration on a phase 1b study will assess the safety and tolerability of Lilly's cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor abemaciclib (LY2835219) in combination with Boehringer Ingelheim's insulin-like growth factor (IGF)-1/IGF-2 ligand neutralizing antibody, BI 836845.

The trial, set to start enrollment later this year, will treat patients diagnosed with hormone-receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) mBC.

Boehringer Ingelheim will  sponsor the study program. If the trial goes well, the companies plan to undertake a midstage study in the future, with an expanded focus on other solid tumors.

BI 836845 binds to both IGF-1 and IGF-2 preventing activation of the respective receptor leading to decreased growth-promoting signalling, which could reduce tumour growth.

In a phase Ib/II trial, BI 836845 demonstrated a better preliminary efficacy and good clinical safety in combination with everolimus and exemestane in patients with HR+ mBC.

Lilly’s abemaciclib is designed to block the growth of cancer cells by inhibiting CDK 4 and 6. It was demonstrated in cell-free enzymatic assays to be most active against Cyclin D 1 and CDK 4.

Lilly Oncology senior vice president, product development and medical affairs Richard Gaynor 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 3 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.”

Image: Lilly corporate headquarters (Indianapolis, Indiana). Photo: courtesy of Eli Lilly and Company.