|By PR Newswire||
|September 29, 2012 07:00 AM EDT||
INDIANAPOLIS, Sept. 29, 2012 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced new data from two Phase II ramucirumab (IMC-1121B) trials in patients with non-small cell lung cancer (NSCLC). Results were presented today during the Lung Cancer – Metastatic Poster Session at the ESMO 2012 Congress (European Society for Medical Oncology), 1:00 p.m. – 2:00 p.m. CET, in Vienna, Austria.
Interim data for a study in chemotherapy-naive patients with advanced NSCLC treated with ramucirumab in combination with first-line ALIMTA® (pemetrexed for injection)/platinum-based chemotherapy (Abstract #1245) and final data for a study in patients treated with ramucirumab in combination with paclitaxel/carboplatinum chemotherapy (Abstract#1287) were presented. The pre-specified interim analysis of progression-free survival (PFS) (Abstract #1245) and final six-month PFS rate (Abstract #1287) support continued development of ramucirumab in lung cancer.
"We are encouraged by these results from two Phase II trials indicating ramucirumab may be beneficial to patients with non-small cell lung cancer," said Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology. "These findings support our ongoing evaluation of ramucirumab for lung cancer patients and will need to be confirmed in larger pivotal studies."
Abstract # 1245
A randomized open-label Phase II study of 140 chemotherapy-naive patients investigated ramucirumab in combination with first-line chemotherapy in advanced nonsquamous NSCLC. Patients were randomized based on histology (nonsquamous [Arms A versus B]; squamous [Arms C versus D]). Enrollment of patients with squamous histology [Arms C versus D] is ongoing. Therapy in Arm A included Lilly's ALIMTA (500 mg/m2) plus carboplatin (AUC=6) or cisplatin (75 mg/m2) once every three weeks, while therapy in Arm B included ramucirumab (10 mg/kg), ALIMTA (500 mg/m2) plus carboplatin (AUC=6) or cisplatin (75 mg/m2) once every three weeks.
The primary endpoint for the interim analysis was PFS. Other interim endpoints included change in tumor size, disease control rate (DCR), and safety. Interim median PFS, based on a pre-specified analysis, was 4.3 months for Arm A, the control arm, and 6.3 months for Arm B, the experimental arm (hazard ratio, 0.48; 90% CI: 0.31-0.74). DCR was 72 percent for Arm A and 87 percent for Arm B.
The most frequently observed (>10%) grade three or higher adverse events (AEs) on Arm B were thrombocytopenia (Arm B, 22% vs Arm A, 19%), neutropenia (18% vs 17%), fatigue (12% vs 17%), anemia (10% vs 16%), hypertension (10% vs 1%) and nausea (10% vs 7%).
Based on these interim analyses of PFS and acceptable tolerability and safety, investigators concluded that ramucirumab supports further study as a potential treatment with first-line platinum-based chemotherapy in nonsquamous NSCLC.
Abstract # 1287
An additional Phase II open-label study investigated ramucirumab in combination with paclitaxel and carboplatin as first-line therapy in patients with advanced NSCLC. Patients with squamous histology and treated brain metastases were allowed. Forty patients received treatment, receiving ramucirumab (10 mg/kg), paclitaxel (200mg/m2) and carboplatin (AUC=6) on day one of a three-week cycle for up to six cycles, followed by maintenance ramucirumab.
The primary endpoint was PFS at six months. Secondary/exploratory endpoints were safety, overall response rate, overall survival rate at one year, pharmacokinetic and pharmacodynamic (PK/PD) profiles and immunogenicity. The overall DCR (CR+PR+SD) reached 90 percent and PFS at six months was 59.0 percent (95% CI = 41.3%-72.9%). Median PFS was 7.85 months.
The most frequently observed (>5%) grade three or higher ramucirumab related AEs were neutropenia (13%), thrombocytopenia (10%), fatigue (8%) and febrile neutropenia (8%).
Investigators concluded that ramucirumab in combination with paclitaxel and carboplatin shows potential efficacy based on the overall DCR (CR+PR+SD) of 90 percent and PFS rate at 6 months of 59.0 percent, and is well tolerated by patients with NSCLC in this Phase II study.
"Ramucirumab is one of the key molecules in Lilly's pipeline and represents one of the largest clinical programs currently underway at Lilly, with six Phase III trials ongoing around the globe including one in lung cancer," said Lilly's Gaynor. "With the breadth of ramucirumab trials we have underway, we have a tremendous opportunity to potentially affect how cancer patients across multiple tumors are being treated."
Notes to Editor
Ramucirumab is a fully human IgG1 monoclonal antibody receptor antagonist designed to bind the extracellular domain of vascular endothelial growth factor (VEGF) receptor-2, thereby blocking the interaction of VEGF ligands (VEGF-A, VEGF-C, and VEGF-D) and inhibiting receptor activation. VEGF receptor 2 is considered a primary mediator of angiogenesis. When activated by VEGF ligands, VEGF receptor 2 promotes endothelial cell proliferation and survival, migration, and vascular permeability.
Ramucirumab, which Lilly gained through its 2008 acquisition of ImClone Systems, is being investigated in clinical trials as monotherapy and in combination with other anticancer therapies.
for the treatment of breast cancer, gastric cancer, non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma, bladder cancer, urethra cancer, ureter cancer, renal pelvis carcinoma, prostate cancer, ovarian cancer and glioblastoma multiforme. It is in late-stage clinical evaluation for the treatment of breast, colorectal, gastric, hepatocellular and lung cancer.
About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer has long been the most common cancer in the world, representing nearly 13 percent of all new cancers and causing nearly 1.4 million deaths annually. About 85 – 90 percent of all lung cancers are NSCLC. The liver, bones and brain are potential targets if the cancerous cells enter the bloodstream.
NSCLC comprises a group of histologies or tumor types differentiated by cellular structure. Nonsquamous histology includes adenocarcinoma and large cell carcinoma, which account for more than half of all NSCLC diagnoses, as well as histologies classified as 'other.'
For more information on NSCLC, please visit www.lillyoncologynewsroom.com.
About Lilly Oncology
For more than four decades, Lilly Oncology, a division of Eli Lilly and Company, has been dedicated to delivering innovative solutions that improve the care of people living with cancer. Because no two cancer patients are alike, Lilly Oncology is committed to developing novel treatment approaches. To learn more about Lilly's commitment to cancer, please visit www.LillyOncology.com
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs.
ATONC00091 29 September 2012
Important Safety Information for ALIMTA® (pemetrexed for injection)
What is the most important information that I should know about ALIMTA?
ALIMTA can suppress bone marrow function, which may cause low blood cell counts.
ALIMTA may not be appropriate for some patients.
If you are allergic to ALIMTA, tell your doctor because you should not receive it.
If you have liver or kidney problems, be sure to tell your doctor. Your dose of ALIMTA may have to be changed, or ALIMTA may not be right for you.
Your doctor will prescribe a medicine called a "corticosteroid" to take for 3 days during each treatment with ALIMTA. Corticosteroids lower your chances for getting skin reactions with ALIMTA.
It is very important to take folic acid and vitamin B12 prior to and during your treatment with ALIMTA to lower your chances of harmful side effects.
- You must take folic acid every day for at least 5 days out of the 7 days before your first dose of ALIMTA. You must keep taking folic acid every day during the time you are getting treatment with ALIMTA, and for 21 days after your last treatment.
- Your doctor will give you vitamin B12 injections while you are getting treatment with ALIMTA. You will get your first vitamin B12 injection during the week before your first dose of ALIMTA, and then about every 9 weeks during treatment.
You will have regular blood tests before and during your treatment with ALIMTA. Your doctor may adjust your dose of ALIMTA or delay your treatment based on the results of your blood test and on your general condition.
What should I tell my doctor before receiving ALIMTA?
If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. ALIMTA may harm your unborn or nursing baby. Your physician may advise you to use effective contraception (birth control) to prevent pregnancy while you are being treated with ALIMTA.
Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements. ALIMTA and other medicines may affect each other, causing serious side effects. Especially, tell your doctor if you are taking medicines called "nonsteroidal anti-inflammatory drugs" (NSAIDs) for pain or swelling.
What are the possible side effects of ALIMTA?
Most patients taking ALIMTA will have side effects. Sometimes it is not always possible to tell whether ALIMTA, another medicine, or the cancer itself is causing these side effects.
Call your doctor right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection, which may be severe and could lead to death.
The most common side effects of ALIMTA when given alone or in combination with cisplatin are:
- Stomach upset, including nausea, vomiting, diarrhea, or constipation. You can obtain medicines to help control some of these symptoms. Call your doctor if you get any of these symptoms.
- Low blood cell counts:
- Low red blood cells. Low red blood cells may make you feel tired, get tired easily, appear pale, and become short of breath.
- Low white blood cells. Low white blood cells may give you a greater chance for infection. If you have a fever (temperature above 100.4°F) or other signs of infection, call your doctor right away.
- Low platelets. Low platelets give you a greater chance for bleeding. Your doctor will do blood tests to check your blood counts before and during treatment with ALIMTA.
- Tiredness. You may feel tired or weak for a few days after your ALIMTA treatments. If you have severe weakness or tiredness, call your doctor.
- Mouth, throat, lip, or food pipe sores (stomatitis, pharyngitis, esophagitis). You may get redness or sores in your mouth, throat, or on your lips, or you may feel pain or difficulty when drinking or swallowing food. These symptoms may happen a few days after ALIMTA treatment. Talk with your doctor if you get any of these symptoms.
- Loss of appetite. You may lose your appetite and lose weight during your treatment. Talk to your doctor if this is a problem for you.
- Rash. You may get a rash or itching during treatment. These reactions usually appear between treatments with ALIMTA and usually go away before the next treatment. Skin reactions or rashes that include blistering or peeling may be severe and could lead to death. Call your doctor if you have any of these symptoms.
Talk with your doctor, nurse, or pharmacist about any side effect that bothers you or that doesn't go away.
These are not all the side effects of ALIMTA. For more information, ask your doctor, nurse, or pharmacist.
How is ALIMTA given?
ALIMTA is slowly infused (injected) into a vein. The injection or infusion will last about 10 minutes. You will usually receive ALIMTA once every 21 days (3 weeks).
For more information about all of the side effects of ALIMTA, please talk with your healthcare team, see the Patient Prescribing Information and full Prescribing Information accompanying this booklet, visit www.ALIMTA.com, or call 1-800-545-5979.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
This press release contains forward-looking statements about the potential of ramucirumab as a treatment of various cancers 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 the product will 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.
 World Health Organization International Agency for Research in Cancer, GLOBOCAN 2008, Section of Cancer Information, http://globocan.iarc.fr/factsheets/cancers/lung.asp, (Accessed June 20, 2012).
 American Cancer Society, "What Is Non-Small Cell Lung Cancer?," December 16, 2010, American Cancer Society, http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/DetailedGuide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer, (October 20, 2011).
 American Cancer Society, "What Is Non-Small Cell Lung Cancer?," October 20, 2009, American Cancer Society, http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/DetailedGuide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer, (October 20, 2011)..
SOURCE Eli Lilly and Company
The Internet of Things (IoT), in all its myriad manifestations, has great potential. Much of that potential comes from the evolving data management and analytic (DMA) technologies and processes that allow us to gain insight from all of the IoT data that can be generated and gathered. This potential may never be met as those data sets are tied to specific industry verticals and single markets, with no clear way to use IoT data and sensor analytics to fulfill the hype being given the IoT today.
Oct. 28, 2016 10:30 AM EDT Reads: 2,925
@ThingsExpo has been named the Top 5 Most Influential M2M Brand by Onalytica in the ‘Machine to Machine: Top 100 Influencers and Brands.' Onalytica analyzed the online debate on M2M by looking at over 85,000 tweets to provide the most influential individuals and brands that drive the discussion. According to Onalytica the "analysis showed a very engaged community with a lot of interactive tweets. The M2M discussion seems to be more fragmented and driven by some of the major brands present in the...
Oct. 28, 2016 09:15 AM EDT Reads: 11,624
Fact: storage performance problems have only gotten more complicated, as applications not only have become largely virtualized, but also have moved to cloud-based infrastructures. Storage performance in virtualized environments isn’t just about IOPS anymore. Instead, you need to guarantee performance for individual VMs, helping applications maintain performance as the number of VMs continues to go up in real time. In his session at Cloud Expo, Dhiraj Sehgal, Product and Marketing at Tintri, wil...
Oct. 28, 2016 09:00 AM EDT Reads: 2,020
Enterprises have been using both Big Data and virtualization for years. Until recently, however, most enterprises have not combined the two. Big Data's demands for higher levels of performance, the ability to control quality-of-service (QoS), and the ability to adhere to SLAs have kept it on bare metal, apart from the modern data center cloud. With recent technology innovations, we've seen the advantages of bare metal erode to such a degree that the enhanced flexibility and reduced costs that cl...
Oct. 28, 2016 08:30 AM EDT Reads: 706
As software becomes more and more complex, we, as software developers, have been splitting up our code into smaller and smaller components. This is also true for the environment in which we run our code: going from bare metal, to VMs to the modern-day Cloud Native world of containers, schedulers and microservices. While we have figured out how to run containerized applications in the cloud using schedulers, we've yet to come up with a good solution to bridge the gap between getting your conta...
Oct. 28, 2016 08:00 AM EDT Reads: 1,643
Personalization has long been the holy grail of marketing. Simply stated, communicate the most relevant offer to the right person and you will increase sales. To achieve this, you must understand the individual. Consequently, digital marketers developed many ways to gather and leverage customer information to deliver targeted experiences. In his session at @ThingsExpo, Lou Casal, Founder and Principal Consultant at Practicala, discussed how the Internet of Things (IoT) has accelerated our abil...
Oct. 28, 2016 08:00 AM EDT Reads: 3,525
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Oct. 28, 2016 08:00 AM EDT Reads: 5,093
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, will discuss how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team a...
Oct. 28, 2016 08:00 AM EDT Reads: 920
Without lifecycle traceability and visibility across the tool chain, stakeholders from Planning-to-Ops have limited insight and answers to who, what, when, why and how across the DevOps lifecycle. This impacts the ability to deliver high quality software at the needed velocity to drive positive business outcomes. In his general session at @DevOpsSummit at 19th Cloud Expo, Eric Robertson, General Manager at CollabNet, will discuss how customers are able to achieve a level of transparency that e...
Oct. 28, 2016 08:00 AM EDT Reads: 1,072
SYS-CON Events announced today that Streamlyzer will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Streamlyzer is a powerful analytics for video streaming service that enables video streaming providers to monitor and analyze QoE (Quality-of-Experience) from end-user devices in real time.
Oct. 28, 2016 07:15 AM EDT Reads: 1,120
You have great SaaS business app ideas. You want to turn your idea quickly into a functional and engaging proof of concept. You need to be able to modify it to meet customers' needs, and you need to deliver a complete and secure SaaS application. How could you achieve all the above and yet avoid unforeseen IT requirements that add unnecessary cost and complexity? You also want your app to be responsive in any device at any time. In his session at 19th Cloud Expo, Mark Allen, General Manager of...
Oct. 28, 2016 07:15 AM EDT Reads: 1,120
Established in 1998, Calsoft is a leading software product engineering Services Company specializing in Storage, Networking, Virtualization and Cloud business verticals. Calsoft provides End-to-End Product Development, Quality Assurance Sustenance, Solution Engineering and Professional Services expertise to assist customers in achieving their product development and business goals. The company's deep domain knowledge of Storage, Virtualization, Networking and Cloud verticals helps in delivering ...
Oct. 28, 2016 07:00 AM EDT Reads: 1,172
Intelligent machines are here. Robots, self-driving cars, drones, bots and many IoT devices are becoming smarter with Machine Learning. In her session at @ThingsExpo, Sudha Jamthe, CEO of IoTDisruptions.com, will discuss the next wave of business disruption at the junction of IoT and AI, impacting many industries and set to change our lives, work and world as we know it.
Oct. 28, 2016 07:00 AM EDT Reads: 596
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Oct. 28, 2016 07:00 AM EDT Reads: 3,778
The IoT industry is now at a crossroads, between the fast-paced innovation of technologies and the pending mass adoption by global enterprises. The complexity of combining rapidly evolving technologies and the need to establish practices for market acceleration pose a strong challenge to global enterprises as well as IoT vendors. In his session at @ThingsExpo, Clark Smith, senior product manager for Numerex, will discuss how Numerex, as an experienced, established IoT provider, has embraced a ...
Oct. 28, 2016 06:45 AM EDT Reads: 1,271