Lilly, Boehringer Ingelheim to jointly study combination therapy for breast cancer

US drug major Eli Lilly (NYSE: LLY) and Boehringer Ingelheim said they will jointly initiate early combination trials in breast cancer.

The trials will study a combination of Lilly’s abemaciclib (LY2835219), cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor, with BI 836845, Boehringer Ingelheim's insulin-like growth factor (IGF)-1/IGF-2 ligand neutralizing antibody.

Richard Gaynor, 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 program 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."

Based on the results of Phase I trials the study may expand to Phase II in other solid tumors, the companies said in a joint statement. Boehringer Ingelheim will be the sponsor of the study program.

Mehdi Shahidi, medical head, solid tumor 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."

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.

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.

Breast cancer is the most common cancer in women worldwide with nearly 1.7 million new cases diagnosed in 2012. In the US this year, about 246,600 new cases of invasive breast cancer will be diagnosed and about 40,450 women will die from breast cancer. Of all early stage breast cancer cases diagnosed in the US, about 30% will become metastatic, spreading to other parts of the body, with an estimated six to 10% of all new breast cancer cases initially being stage IV, or metastatic.

Anjali Shukla