Lilly and AstraZeneca Expand Immuno-Oncology Research Collaboration with New Combinations

INDIANAPOLIS, Oct. 22, 2015 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and AstraZeneca (NYSE: AZN) today announced an extension to their existing immuno-oncology collaboration exploring novel combination therapies for the treatment of patients with solid tumors.

Under the terms of the expanded agreement, Lilly and AstraZeneca will evaluate the safety and efficacy of a range of additional combinations across the companies' complementary portfolios. Lilly will lead the execution of the studies, while both companies will contribute resources. Additional details of the collaboration, including tumors to be studied and financial terms, were not disclosed.

AstraZeneca's anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), will be combined with Lilly molecules that target the immune system, including:

The companies will also explore other combinations targeting tumor drivers and resistance mechanisms, including:

Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology, said, "The expansion of Lilly's research partnership with AstraZeneca will explore the far-reaching potential of combining novel targeted therapies. Our respective pipelines afford multiple targeted options to create innovative combinations in immuno-oncology and beyond, that we hope will lead to future cancer treatment options."

Mondher Mahjoubi, senior vice president, global product strategy for oncology at AstraZeneca, said, "The extension of our collaboration with Lilly further supports our combination-focused oncology strategy and adds to our broad development program across small molecules and immunotherapies."

Earlier this year, Lilly and AstraZeneca announced a Phase I clinical trial collaboration to evaluate the safety and preliminary efficacy of combining durvalumab and ramucirumab as a treatment for patients with advanced solid tumors.

In addition to combinations within the company's own pipeline of immuno-oncology, biologics and small molecule investigational medicines, Lilly has a broad program of combination clinical trials underway with a range of partners.

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NOTES TO EDITORS

About CYRAMZA®(ramucirumab) 
In the U.S., CYRAMZA (ramucirumab) is approved for use as a single agent or in combination with paclitaxel as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. It is also approved in combination with docetaxel as a treatment for people with metastatic non-small cell lung cancer (NSCLC) whose cancer has progressed on or after platinum-based chemotherapy. Additionally, it is approved with FOLFIRI as a treatment for people with metastatic colorectal cancer (mCRC) whose cancer has progressed on or after therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

There are several additional studies underway or planned to investigate CYRAMZA as a single agent and in combination with other anti-cancer therapies for the treatment of multiple tumor types. This broad global development program has enrolled more than 7,000 patients across more than 50 trials of CYRAMZA worldwide. 

CYRAMZA is an antiangiogenic therapy. It is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. CYRAMZA inhibited angiogenesis in an in vivo animal model.

INDICATIONS

Gastric Cancer
CYRAMZA, as a single agent or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

Non-Small Cell Lung Cancer
CYRAMZA, in combination with docetaxel, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA.

Colorectal Cancer
CYRAMZA, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

IMPORTANT SAFETY INFORMATION FOR CYRAMZA


WARNING: HEMORRHAGE, GASTROINTESTINAL PERFORATION, AND IMPAIRED WOUND HEALING

 

Hemorrhage: CYRAMZA increased the risk of hemorrhage and gastrointestinal hemorrhage, including severe and sometimes fatal hemorrhagic events. Permanently discontinue CYRAMZA in patients who experience severe bleeding.


Gastrointestinal Perforation: CYRAMZA can increase the risk of gastrointestinal perforation, a potentially fatal event. Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation.


Impaired Wound Healing: Impaired wound healing can occur with antibodies inhibiting the VEGF pathway. Discontinue CYRAMZA therapy in patients with impaired wound healing. Withhold CYRAMZA prior to surgery and discontinue CYRAMZA if a patient develops wound healing complications.

Warnings and Precautions

Hemorrhage

Arterial Thromboembolic Events (ATEs)

Hypertension

Infusion-Related Reactions (IRRs)

Gastrointestinal Perforations

Impaired Wound Healing

Clinical Deterioration in Child-Pugh B or C Cirrhosis

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

Proteinuria Including Nephrotic Syndrome

Thyroid Dysfunction

Embryofetal Toxicity

Most Common Adverse Reactions—Single Agent

Most Common Adverse Reactions—Combination With Paclitaxel

Most Common Adverse Reactions—Combination With Docetaxel

Most Common Adverse Reactions—Combination With FOLFIRI

Drug Interactions

Use in Specific Populations

Please see full Prescribing Information for CYRAMZA, including Boxed Warnings for hemorrhage, gastrointestinal perforation, and impaired wound healing.

RB-P HCP ISI 17SEP2015

About Lilly Oncology 
For more than fifty years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. To learn more about Lilly's commitment to people with cancer, please visit www.LillyOncology.com.

About Eli Lilly and Company 
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.

About AstraZeneca in Oncology 
Oncology is a therapeutic area in which AstraZeneca has deep-rooted heritage. It will be potentially transformational for the company's future, becoming the sixth growth platform. Our vision is to help patients by redefining the cancer treatment paradigm and one day eliminate cancer as cause of death. By 2020, we are aiming to bring six new cancer medicines to patients.

Our broad pipeline of next-generation medicines is focused on four main disease areas - lung, ovarian, breast, and hematological cancers. These are being targeted through four key platforms - immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates.

About AstraZeneca 
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

CYRAMZA is a trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

P-LLY

Lilly Forward-Looking Statement

This press release contains "forward-looking statements" (as that term is defined in the United States Private Securities Litigation Reform Act of 1995) regarding the research collaboration between AstraZeneca and Lilly. This press release reflects Lilly's current beliefs. However, there are substantial risks and uncertainties in the process of drug research, development and commercialization. Among other risks, there can be no guarantee that these investigational combination regimens will receive regulatory approval, or, if approved, will achieve intended benefits or become commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ materially from Lilly's expectations, please see the company's latest Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements for events occurring after the date of this release.

Refer to:

Karen Glowacki; kglowacki@lilly.com; 317-370-1177 (Lilly)


Neil Hochman; n.hochman@togorun.com; 212-453-2067 (TogoRun)  

 

 

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SOURCE Eli Lilly and Company

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