Boehringer Ingelheim and Lilly Announce Clinical Trial Collaboration in Metastatic Breast Cancer

INGELHEIM, Germany - Wednesday, July 13th 2016 [ME NewsWire]

• Study to evaluate potential of novel combination therapy for hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (mBC)

• Boehringer Ingelheim’s IGF mAB BI 836845 and Lilly’s CDK 4 and 6 inhibitor abemaciclib have shown promising early phase results in metastatic breast cancer

(BUSINESS WIRE)-- Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) today announced 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. 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.

“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, 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.

Lilly Forward-Looking Statement

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about abemaciclib as a potential treatment for patients with metastatic breast cancer and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialisation. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that abemaciclib will achieve its primary study endpoints or receive regulatory approvals. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Intended audiences:

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/press-release/boehringer-ingelheim-and-lilly-announce-clinical-trial-collaboration-metastatic-breast

Contacts

Boehringer Ingelheim

Corporate Communications

Media + PR

Dr. Reinhard Malin

Phone: +49 6132 – 77 90815

Fax: +49 6132 – 77 6601

Email: press@boehringer-ingelheim.com









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