Indianapolis-based Eli Lilly and Co. (NYSE: LLY) says a potential treatment for a certain type of lung cancer has resulted in a “statistically significant” improvement in overall survival during a late-stage trial. The company says it plans to submit necitumumab to regulators by the end of the year.

May 14, 2014

News Release

Indianapolis, Ind. — Lung cancer patients with metastatic squamous cell carcinoma have seen few treatment advancements over the last two decades, leaving these patients with a poor prognosis. This is in contrast to the progress seen in nonsquamous non-small cell lung cancer (NSCLC).[1] Results from the largest ever Phase III trial in first-line squamous NSCLC announced by Eli Lilly and Company (NYSE: LLY) today provide the first detailed look at a potential new treatment option for these patients.

Necitumumab (IMC-11F8) is a recombinant human IgG1 monoclonal antibody designed to target the human epidermal growth factor receptor 1 (EGFR). In the Phase III SQUIRE trial, patients with stage IV metastatic squamous NSCLC showed a statistically significant improvement in overall survival (HR=0.84, p=0.012) with a median survival of 11.5 months when receiving necitumumab in combination with gemcitabine and cisplatin as a first-line treatment, as compared to 9.9 months for those treated with chemotherapy alone. Consistent efficacy results were observed across endpoints and subgroups. Grade 3 or higher adverse events occurring more frequently in patients on the necitumumab arm were hypomagnesemia and rash. The SQUIRE study results (Abstract #8008) were released in advance of the American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago, Ill. Additional safety and efficacy information will be presented at the meeting.

“The SQUIRE trial results offer an important step in our pursuit of improving outcomes for patients with advanced squamous NSCLC,” said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. “With these findings, Lilly anticipates a regulatory submission of necitumumab before the end of 2014.”

Lung cancer is the leading cause of cancer death in the U.S. and most other countries. NSCLC is much more common than other types of lung cancer, and accounts for 85 percent of all lung cancer cases. Patients with squamous cell carcinoma represent about 30 percent of all patients affected by NSCLC. Advanced squamous NSCLC represents a high unmet medical need.[2] Improving treatment in this setting has been particularly challenging as patients often have co-morbidities and, unlike nonsquamous NSCLC, research has yet to confirm a molecular oncogenic target that could drive treatment decisions for patients with this disease.[3]

“While there have been several attempts to make progress to address this unmet need, clinical advances in squamous non-small cell lung cancer have been minimal in the last twenty years,” said Nick Thatcher, Ph.D., FRCP., professor of oncology, University of Manchester, Christie Hospital NHS Trust in Manchester, United Kingdom and the SQUIRE principal investigator. “The addition of necitumumab to the current chemotherapy regimen of gemcitabine and cisplatin opens the door to a potential new approach to treat patients with advanced squamous NSCLC.”

About the SQUIRE Study

SQUIRE enrolled 1,093 patients (age ≥ 18 years, ECOG PS 0-2) with histologically- or cytologically-confirmed, stage IV squamous NSCLC, who had received no prior therapy for metastatic disease. The primary endpoint was overall survival. Patients were randomized to receive first-line necitumumab plus chemotherapy consisting of gemcitabine and cisplatin in study Arm A, or gemcitabine-cisplatin chemotherapy alone in study Arm B. Patients underwent radiographic assessment of disease status (computed tomography or magnetic resonance imaging) every six weeks (± 3 days), until radiographic documentation of progressive disease (PD). Combination chemotherapy continued for a maximum of six cycles in each arm (or until there was radiographic documentation of PD, toxicity requiring cessation, or withdrawal of consent); patients in Arm A with no progression continued to receive single-agent necitumumab (IMC-11F8) until there was radiographic documentation of PD, toxicity requiring cessation, or withdrawal of consent.

About Necitumumab

Necitumumab is a recombinant human IgG1 monoclonal antibody that is designed to block the ligand binding site of the human epidermal growth factor receptor 1(EGFR). Activation of EGFR has been correlated with malignant progression, induction of angiogenesis and inhibition of apoptosis or cell death.

About Lung Cancer

Lung cancer is the leading cause of cancer death in the U.S. and most other countries, killing nearly 1.6 million people worldwide each year.[4] In the U.S., lung cancer is responsible for nearly 30 percent of all cancer deaths, more than those from breast, colon and prostate cancers combined.[5] NSCLC is much more common than other types of lung cancer, and accounts for 85 percent of all lung cancer cases. Patients with squamous cell carcinoma represent about 30 percent of all patients affected by NSCLC, while non-squamous patients represent about 70 percent.[6]

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

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 and


This press release contains forward-looking statements about the potential of necitumumab as a treatment for patients with squamous non-small cell lung cancer and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that future studies will be positive or that necitumumab will receive regulatory approvals or prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

Important Safety Information for GEMZAR® (gemcitabine for injection)

Myelosuppression is usually the dose-limiting toxicity with GEMZAR therapy.


GEMZAR is contraindicated in patients with a known hypersensitivity to gemcitabine.

Warnings and Precautions

Patients receiving therapy with GEMZAR should be monitored closely by a physician experienced in the use of cancer chemotherapeutic agents.

Infusions of GEMZAR longer than 60 minutes or dosing more frequently than weekly resulted in an increased incidence of clinically significant hypotension, severe flu-like symptoms, myelosuppression, and asthenia. The half-life of GEMZAR is influenced by the length of the infusion.

Myelosuppression manifested by neutropenia, thrombocytopenia, and anemia occurs with GEMZAR as a single agent, and the risks are increased when GEMZAR is combined wi

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