On July 13, 2016 Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) reported 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 (Press release, Boehringer Ingelheim, JUL 13, 2016, View Source [SID:1234513868]). 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "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
Dr. Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented, " 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."

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+ mBC.1 Lilly’s abemaciclib is designed to block the growth of cancer cells by specifically inhibiting CDK 4 and 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 6.

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.

About Metastatic Breast Cancer
Breast cancer is the most common cancer in women worldwide with nearly 1.7 million new cases diagnosed in 2012.2 In the U.S. this year, approximately 246,600 new cases of invasive breast cancer will be diagnosed and about 40,450 women will die from breast cancer.3 Of all early stage breast cancer cases diagnosed in the U.S., approximately 30 percent will become metastatic, spreading to other parts of the body, with an estimated six to 10 percent of all new breast cancer cases initially being stage IV, or metastatic.4 Approximately 75% of breast cancers are hormone receptor-positive and are typically managed with endocrine therapies, including aromatase inhibitors and selective oestrogen receptor modulators.5 Metastatic breast cancer is considered incurable, but is generally treatable.

About BI 836845
BI 836845 is an investigational compound in Phase II clinical development. It 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.