Positive Opinion is the First Regulatory Action for Necitumumab in Europe
INDIANAPOLIS, Dec. 18, 2015 /PRNewswire/ -- Eli Lilly and Company announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for a new lung cancer treatment. If approved by the European Commission, necitumumab (Portrazza((TM))), in combination with gemcitabine and cisplatin chemotherapy, would be the first biologic for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy for this condition.
"Today's news is an encouraging step forward in bringing EU patients a much-needed front-line treatment option for this devastating type of lung cancer," said Richard Gaynor, M.D., senior vice president of product development and medical affairs for Lilly Oncology. "Very little progress has been made for these patients over the past 20 years and few treatment options are available. If approved in the EU, necitumumab would be an important advancement against a disease with a current five-year survival rate of less than five percent in patients with metastatic disease."
This is the first regulatory action for necitumumab in Europe and follows the U.S. Food and Drug Administration (FDA) approval in November 2015. Following a positive CHMP opinion, the European Commission generally accepts the recommendation and usually issues its final decision on marketing authorisation within two to three months.
The CHMP opinion is based on the results of SQUIRE, an open-label, randomised, multi-center Phase III trial that compared front-line treatment with necitumumab in combination with gemcitabine and cisplatin to treatment with gemcitabine and cisplatin alone in patients with advanced squamous NSCLC.
In a separate press release issued today, Lilly also announced that it received two positive CHMP opinions for ramucirumab (CYRAMZA()). The first is in combination with docetaxel for the treatment of adult patients with locally advanced or metastatic NSCLC with disease progression after platinum-based chemotherapy. The second is in combination with FOLFIRI for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.
Notes to Editor
About the SQUIRE Trial
SQUIRE was an open-label, randomised, multi-center Phase III trial that compared first-line treatment with necitumumab in combination with gemcitabine and cisplatin to treatment with gemcitabine and cisplatin alone in patients with metastatic squamous NSCLC. The main outcome measure, or primary endpoint, was overall survival. The SQUIRE study was conducted across 184 investigative sites in 26 countries(1) and enrolled 1,093 people with stage IV squamous NSCLC. Of those enrolled, 91 percent had metastatic disease at two or more sites, indicating a high metastatic disease burden for the majority of these patients. Nearly 90 percent of patients in the SQUIRE study were assessable for EGFR protein expression by immunohistochemistry (IHC). Of these, more than 95 percent of patients had EGFR expressing tumors.
About Squamous Non-Small Cell Lung Cancer (NSCLC)
NSCLC is the most common type of lung cancer, and accounts for about 85 percent of all lung cancer cases.(2) Squamous NSCLC, which represents about 30 percent of all lung cancer cases, is a devastating, difficult-to-treat form of the disease.(2,3,4,5 )Patients face an imposing disease and symptom burden with very poor prognosis; the five-year survival rate for patients with metastatic disease is less than five percent.(6) Until now, little progress has been made over the past two decades, particularly in the first-line setting, leaving a significant unmet medical need.(7)
About Necitumumab (Portrazza)
Necitumumab (Portrazza) 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. As demonstrated in preclinical studies, EGFR plays a role in the formation (tumourigenesis) and spread (metastasis) of tumours.(8)
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.
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 [http://www.lilly.com/] and newsroom.lilly.com/social-channels [http://newsroom.lilly.com/social-channels].
Portrazza((TM)) and CYRAMZA() are trademarks owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.
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 the potential of necitumumab (Portrazza((TM))), as a treatment of advanced squamous non-small cell lung cancer (NSCLC) and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialisation. There can be no guarantee that future study results and patient experience will be consistent with the study findings to date. There can also be no guarantee that necitumumab will receive regulatory approval for any future indications or that it will prove to be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ 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.
(1) Thatcher, Nick et al. (2015). Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. The Lancet Oncology, Volume 16, Issue 7, 763 - 774.
(2) American Cancer Society. What is non-small cell lung cancer? Revised March 4, 2015. http://www.cancer.org/cancer/lungcancer-non-smallcell/detail.... Accessed November 13, 2015.
(3) Nichols, L., Saunders, R., & Knollmann, F. (2012). Causes of Death of Patients With Lung Cancer. Archives of Pathology & Laboratory Medicine, 1552-1557. doi:10.5858/arpa.2011-0521-OA.
(4) Rosado-De-Christenson, M., Templeton, P., & Moran, C. (1994). Bronchogenic carcinoma: Radiologic-pathologic correlation. Radiographics, 18 Dic. (2) - , 429-446.
(5) Rubin, E., & Reisner, H. (Eds.). (2009). Essentials of Rubin's Pathology, 5th Edition (5th ed., p. 1042). Philadelphia, PA: Lippincott Williams & Wilkins.
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