Novartis presents oncology research advances with new data on Zykadia(TM), Afinitor® and key pipeline compounds at ESMO 2014
Latest Zykadia data in patients with ALK+ non-small cell lung cancer, including updated brain metastases analysis from pivotal trial
Final overall survival data from Phase III trial of Afinitor in advanced pancreatic neuroendocrine tumors (pNET)
Findings on Novartis pipeline compounds that target underlying cause of key diseases, including breast cancer, advanced basal cell carcinoma and melanoma
Basel, September 17, 2014 - Novartis will showcase new data at the European Society for Medical Oncology (ESMO) Congress, September 26-30, 2014 in Madrid, Spain. In keeping with the meeting's focus on "Precision Medicine in Cancer Care," Novartis will feature compounds that target specific pathways and molecular markers involved in cancer.
The Novartis data include new analyses from the pivotal trial evaluating Zykadia(TM) (ceritinib) in ALK+ non-small cell lung cancer (NSCLC), overall survival results from the pivotal trial of the mTOR inhibitor Afinitor® (everolimus) in advanced pancreatic neuroendocrine tumors (pNET), and updated patient management data for Afinitor in advanced breast cancer. In addition, Novartis will present study results on key pipeline compounds, including data for the Hedgehog inhibitor LDE225 (sonidegib) in advanced basal cell carcinoma, the CDK4/6 inhibitor LEE011 and the BRAF inhibitor LGX818 (encorafenib) in melanoma, the MEK inhibitor MEK162 (binimetinib) in NRAS-mutant melanoma, and PI3K inhibitors BKM120 (buparlisib) and BYL719 (alpelisib) in solid tumors.
"At ESMO 2014 we will present new data on key compounds that demonstrate the breadth of the biological markers we target," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "By understanding what drives different cancers to develop and grow, our clinical program has led to the development of precise therapies for patients with the specific genetic profile targeted by these treatments, enabling us to make a difference for people living with these diseases."
More than 30 abstracts involving Novartis compounds will be presented at ESMO 2014, including:
Description of study
Efficacy and Safety of Ceritinib in Patients with Advanced Anaplastic Lymphoma Kinase (ALK)-rearranged (ALK+) Non-small Cell Lung Cancer (NSCLC): An Update of ASCEND-1
Evaluation of Ceritinib-treated Patients with Anaplastic Lymphoma Kinase rearranged (ALK+) Non-small Cell Lung Cancer (NSCLC) and Brain Metastases in the ASCEND-1 study
Everolimus for the Treatment of Advanced Pancreatic Neuroendocrine Tumors (pNET): Final Overall Survival (OS) Results of a Randomized, Double-blind, Placebo (PBO)-Controlled, Multicenter Phase III Trial (RADIANT-3)
Everolimus + Exemestane
Breast Cancer Treatment with Everolimus and Exemestane for ER+ Women - Results of the 2nd interim analysis of the non-interventional trial BRAWO
Randomized, double-blind study of sonidegib (LDE225) in patients (pts) with advanced basal cell carcinoma (BCC)
LDE225 (sonidegib) + BKM120 (buparlisib)
Dose-escalation study of sonidegib (LDE225) plus buparlisib (BKM120) in patients with advanced solid tumors
LEE011 + LGX818 (encorafenib)
Phase Ib/II study of LEE011 (CDK4/6 inhibitor) and LGX818 (BRAF inhibitor) in BRAF-mutant melanoma
Overall Survival and Biomarker Results from a Phase 2 Study of MEK1/2 Inhibitor Binimetinib (MEK162) in Patients With Advanced NRAS-mutant Melanoma
Phase I study of the PI3Kalpha inhibitor BYL719, as a single agent in patients with advanced solid tumors (aST)
Product Information Approved indications for products vary by country and not all indications are available in every country. The product safety and efficacy profiles have not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that compounds will become commercially available with additional indications.
For full prescribing information including important safety information about marketed products, please visit the following websites: www.zykadia.com and www.afinitor.com.
Because LDE225, MEK162, BKM120, BYL719, LEE011 and LGX818 are investigational compounds, the safety and efficacy profiles have not yet been fully established. Access to these investigational compounds is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the potential benefits and risks of the compound. Because of the uncertainty of clinical trials, there is no guarantee that LDE225, MEK162, BKM120, BYL719, LEE011 and LGX818 will ever be commercially available anywhere in the world.
Disclaimer The foregoing release contains forward-looking statements that can be identified by words such as "pipeline," "will," "emerging," "investigational," or similar terms, or by express or implied discussions regarding potential new indications or labeling for Zykadia and Afinitor, potential marketing approvals for LDE225, MEK162, BKM120, BYL719, LEE011 and LGX818, or regarding potential future revenues from such products and investigational compounds. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that either Zykadia or Afinitor will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that LDE225, MEK162, BKM120, BYL719, LEE011 or LGX818 will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that any such products or investigational compounds will be commercially successful in the future. In particular, management's expectations regarding such products and investigational compounds could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.