Brain Tumor, Scientists Find Cause Of The Tumors, Gene Mutations.

Scientists from Johns Hopkins University and Duke University have completed a comprehensive map of genetic mutations occurring in the second-most common form of brain cancer, oligodendroglioma. The papers were published the August 4 ahead-of-print issue of the journal Science.
These findings were only possible due to the advancement of science and technology.

"The team used whole genome sequencing technology so that no genes would be excluded, and we found to our surprise that one gene, on chromosome 19, was mutated in six out of the seven initial tumor specimens we sequenced,A mutation frequency of 85 percent is very high." said Hai Yan, MD, PhD, Duke associate professor of pathology and co-corresponding author of the study.

Press release by John Hopkins (the Press release by Duke University is here);

Release Date: 08/04/2011

--Findings reveal cause of the tumors

Johns Hopkins Kimmel Cancer Center scientists have completed a comprehensive map of genetic mutations occurring in the second-most common form of brain cancer, oligodendroglioma. The findings, reported in the Aug. 4 issue of Science, also appear to reveal the biological cause of the tumors, they say.

To create the map, the scientists sequenced protein-coding genes in seven oligodendroglioma tissue samples, and focused attention on recurring mutations in two genes not previously associated with these tumors – CIC and FUBP1. The investigators say that CIC and FUBP1 are known to regulate cell-signaling processes, and CIC mutations have been rarely linked to sarcoma, breast and prostate cancers.

More mutations in the two genes were found in an additional 27 oligodendroglioma samples. In all, two-thirds of the samples studied had CIC and FUBP1 mutations.

“Whenever we find genes mutated in a majority of tumors, it is likely that the pathway regulated by that gene is critical for the development and biology of the tumor,” says Nickolas Papadopoulos, Ph.D., associate professor of oncology at the Johns Hopkins Kimmel Cancer Center.

In brain cancer, the Johns Hopkins investigators say CIC and FUBP1 mutations may be the “missing link” in what scientists describe as a “two-hit” theory of cancer development. The theory is based on the fact that each cell in the human body has two copies of 23 chromosomes containing thousands of protein-producing genes. If a gene on one chromosome is damaged or deleted, the other copy makes up for the loss of protein. But if the second copy fails as well, the cell cannot make the proper protein and may become cancerous.

In oligodendrogliomas, the “first hit” has long been known to occur in regions of chromosome 1 and 19, which fuse together resulting in a loss of many genes on both chromosomes. Up to 70 percent of oligodendroglioma patients have these DNA fusions, and most of them respond better to chemotherapy and radiation than those who lack the deletions in the chromosomes. For more than a decade, researchers have been looking for evidence of a “second hit” in specific mutated genes that allow oligodendrogliomas to develop.

In the current study, the Johns Hopkins investigators found mutations in the remaining copies of the CIC and FUBP1 genes on chromosomes 1 and 19, suggesting that these mutations represent the second hit needed to create cancer.

“Thanks to the Human Genome Project and advances in cancer genome sequencing, a single study can now resolve decade-old questions and reveal the genetics of this brain cancer,” says Kenneth Kinzler, Ph.D., professor and co-director of the Ludwig Center at Johns Hopkins. “Knowing the genetic roadmap of a cancer is the key to attacking it.”

Oligodendrogliomas account for up to 20 percent of brain cancers and more commonly occur in younger people aged 30 to 45. The cancer forms most often in the frontal lobe of the brain in cells that coat neurons. Median survival of 10 years is considered far better than other brain cancers. Oligodendrogliomas are treated initially with surgery, followed by chemotherapy and radiation.

The research team says its next step will be to test whether patients with CIC and FUBP1 mutations have the same favorable prognosis as those who have the chromosome 1 and 19 fusion, says Chetan Bettegowda, M.D., Ph.D., chief resident in the Department of Neurosurgery at Johns Hopkins.

“We can focus now on when these mutations develop during tumor formation, whether they can guide prognosis, and how they might form targets for therapy,” says Bettegowda.

Bettegowda says the gene map uncovered mutations in other genes, such as PIK3CA, which have been well-studied in cancer. It is possible, he says, that oligodendroglioma patients with mutations in PIK3CA or other genes could be enrolled in current clinical trials using experimental therapies that target these mutations.

Funding for the research was provided by the Virginia and D.K. Ludwig Fund for Cancer Research, the Pediatric Brain Tumor Foundation, the Duke Comprehensive Cancer Center Core, the Burroughs Wellcome Fund, the James S. McDonnell Foundation, state funding from Sao Paulo (FAPESP), the National Cancer Institute and National Institutes of Health.

Contributors to the research include Nishant Agrawal, Yuchen Jiao, Mark Sausen, Laura D. Wood, Ralph H. Hruban, Fausto J. Rodriguez, Daniel P. Cahill, Gregory Riggins, Victor Velculescu and Bert Vogelstein of Johns Hopkins; Roger McLendon, Darell Bigner and Hai Yan of Duke University; and Sueli Mieko Oba-Shinjo and Suely Kazue Nagahashi Marie of the University of Sao Paulo, Brazil.

Under agreements between the Johns Hopkins University, Genzyme, Exact Sciences, Inostics, Qiagen, Invitrogen and Personal Genome Diagnostics, Papadopoulos, Vogelstein, Kinzler and Velculescu are entitled to a share of the royalties received by the university on sales of products related to genes and technologies described in this manuscript. Papadopoulos, Vogelstein, Kinzler, and Velculescu are co-founders of Inostics and Personal Genome Diagnostics, are members of their Scientific Advisory Boards, and own Inostics and Personal Genome Diagnostics stock, which is subject to certain restrictions under Johns Hopkins University policy.

Stand Up To Cancer, Where Your Money Goes!

Stand Up To Cancer PI3K Pathway scientists explain their ongoing progress and look towards the future.

If you ever wondered where all the money you donated to Stand Up To Cancer go. Please watch the above video. And if you have not donated yet or want to learn more about Stand Up To Cancer PI3K Pathway, follow the link below.

"Rarely do you see responses with investigational drugs in phase one but with these compounds some very dramatic responses are being seen." - Dr. Lewis C. Cantley SU2C PI3K Dream Team Leader
SU2C, Stand Up To Cancer

Sarilumab Succeeds In Treating Rheumatoid Arthritis But Fails In Addressing Ankylosing Spondylitis in Phase 2b Trial

Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the outcome from Phase 2b trials in rheumatoid arthritis (RA) and ankylosing spondylitis (AS) with sarilumab (REGN88/SAR153191), a novel, high-affinity, subcutaneously administered, fully-human antibody targeting the interleukin-6 receptor (IL-6R).
Sarilumab Succeeded in treating Rheumatoid Arthritis but failed in addressing Ankylosing Spondylitis, a long-term disease that causes inflammation of the joints between the spinal bones, and the joints between the spine and pelvis in Phase 2b Trial.

"Following these encouraging Phase 2b results in rheumatoid arthritis, the companies are currently discussing the dose(s) of sarilumab to advance into the Phase 3 portion of the MOBILITY trial," said Elias Zerhouni, President, Global Research & Development, Sanofi.

Further details about the MOBILITY trial are available at http://clinicaltrials.gov/ct2/results?term=SAR+153191+mobility.

Press release;

PARIS and TARRYTOWN, N.Y., July 12, 2011 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced results from Phase 2b trials in rheumatoid arthritis (RA) and ankylosing spondylitis (AS) with sarilumab (REGN88/SAR153191), a novel, high-affinity, subcutaneously administered, fully-human antibody targeting the interleukin-6 receptor (IL-6R).

The Phase 2b MOBILITY trial in rheumatoid arthritis demonstrated that patients treated with sarilumab in combination with a standard RA treatment, methotrexate (MTX), achieved a significant and clinically meaningful improvement in signs and symptoms of moderate-to-severe RA compared to patients treated with MTX alone. The MOBILITY study is a 306-patient, dose-ranging, multi-national, randomized, multi-arm, double-blind, placebo-controlled study, that compared five different dose regimens of sarilumab in combination with MTX to placebo plus MTX. The primary endpoint of the study was the proportion of patients achieving at least a 20% improvement in RA symptoms (ACR20) after 12 weeks.

In the MOBILITY trial, there was a dose response observed in patients receiving sarilumab in combination with MTX. An ACR20 response after 12 weeks was seen in 49.0% of patients receiving the lowest sarilumab dose regimen and 72.0% of patients receiving the highest dose regimen compared to 46.2% of patients receiving placebo and MTX (p=0.02, corrected for multiplicity, for the highest sarilumab dose regimen). The most common adverse events (>5%) reported more frequently in active treatment arms included infections (non-serious), neutropenia, and liver function test abnormalities. The types and frequencies of adverse events were consistent with those previously reported with IL-6 inhibition. The incidence of serious adverse events among the five sarilumab treatment groups and placebo group were comparable.

Sarilumab also demonstrated significant benefit compared to placebo in secondary endpoints, including ACR 50, ACR 70, and DAS 28 scores, additional measures of clinical activity used in RA trials.

"Following these encouraging Phase 2b results in rheumatoid arthritis, the companies are currently discussing the dose(s) of sarilumab to advance into the Phase 3 portion of the MOBILITY trial," said Elias Zerhouni, President, Global Research & Development, Sanofi.

"The MOBILITY results provide evidence that IL-6R blockade with sarilumab represents a promising new anti-inflammatory investigational therapy for reducing RA disease symptoms. We are very pleased that the first of our novel VelocImmune^®derived antibodies is poised to enter Phase 3 development," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Research Laboratories.

In the Phase 2b ALIGN trial in ankylosing spondylitis (AS), sarilumab did not demonstrate significant and clinically meaningful improvements in signs and symptoms of active AS compared to placebo in patients who had inadequate response to NSAIDs. Sarilumab was generally well tolerated. The most common adverse events reported more frequently in active treatment arms included infections and neutropenia.

Full data of both Phase 2b trials will be submitted for presentation at an upcoming scientific conference.

About Sarilumab

Sarilumab (REGN88/ SAR153191) is the first fully human monoclonal antibody directed against the alpha subunit of the IL-6 receptor complex (IL-6R alpha). Sarilumab is a high affinity, sub-cutaneously delivered, specific inhibitor of IL-6 signaling. It blocks the binding of IL-6 to its receptor and interrupts the resultant cytokine-mediated inflammatory signaling cascade. Sarilumab was developed using Regeneron VelocImmune^® antibody technology.

About the MOBILITY Trial

The MOBILITY trial is a randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of sarilumab on top of MTX in patients with active RA who are inadequate responders to MTX therapy. The primary objective of part A of the dose ranging MOBILITY trial was to demonstrate that sarilumab on top of MTX is effective in reducing the signs and symptoms of RA at 12 weeks. The five doses tested were 100 milligrams (mg) and 150 mg every week and 100 mg, 150 mg and 200 mg every other week. The primary objective of part B of the MOBILITY trial will be to demonstrate that sarilumab on top of MTX is effective in reducing the signs and symptoms of RA at 24 weeks. Further details about the MOBILITY trial are available at http://clinicaltrials.gov/ct2/results?term=SAR+153191+mobility.

About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease affecting approximately 0.5%–1% of the global adult population. Abnormal immune response causes an inflamed, thickened synovium, the membrane that lines the joint. As synovitis expands, the inflammatory process can damage the bone and cartilage of the joint and the surrounding tissues. RA-related inflammation can involve the heart and the lung. In 10% of patients with RA the liver is affected. Complications of RA include anemia and leucopenia. At times RA can be very painful and affect a person's ability to carry out everyday tasks. Most people with RA experience periods when their symptoms worsen (flares or active disease) separated by periods in which the symptoms improve. Studies suggest that blockade of IL-6 signaling, one of several key cytokines involved in the inflammatory processes related to RA, may reduce inflammation of the joints, prevent long-term damage and relieve certain systemic effects of RA such as decreased hemoglobin, fatigue and osteoporosis.

About the ALIGN Trial

The 300-patient ALIGN trial is a randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of sarilumab in patients with AS who had an inadequate response to NSAIDs. The primary outcome measure of the trial was the percentage of patients who achieved a 20% improvement in AS International Working Group Criteria for improvement (ASAS20) at 12 weeks. The secondary endpoints included ASAS40 response, partial remission, and changes in disease activity, safety and tolerability. In the ALIGN trial, the same dose regimens were tested as in part A of the MOBILITY trial. Further details about the ALIGN trial can be found at http://clinicaltrials.gov/ct2/results?term=SAR153191+align.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed inParis (EURONEXT: SAN) and in New York (NYSE: SNY).

About Regeneron Pharmaceuticals, Inc.

Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST^® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in Phase III clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration, central retinal vein occlusion, and diabetic macular edema), and certain cancers. Additional therapeutic candidates developed from proprietary Regeneron technologies for creating fully human monoclonal antibodies are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer. Additional information about Regeneron and recent news releases are available on Regeneron's web site at www.regeneron.com.

Sanofi Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2010. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Regeneron Forward-Looking Statements

This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future financial performance of Regeneron, and actual events or results may differ materially from these forward-looking statements. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's product candidates and research and clinical programs now underway or planned, the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's product and drug candidates, competing drugs that may be superior to Regeneron's product and drug candidates, uncertainty of market acceptance of Regeneron's product and drug candidates, unanticipated expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any license or collaboration agreement, including Regeneron's agreements with the Sanofi Group and Bayer HealthCare, to be canceled or terminated without any product success, and risks associated with third party intellectual property and pending or future litigation relating thereto. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2010 and Form 10-Q for the quarter ended March 31, 2011. Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise, unless required by law.

Contacts
Sanofi:
Global Product Communications	Corporate Media Relations
Ingrid Gorg-Armbrecht	Marisol Peron
Tel: +33 (0) 1 53 77 46 25	Tel: +33 (0) 1 53 77 45 02
Mobile: + 33(0) 6 38 10 50 87	Mobile: +33 (0) 6 08 18 94 78
E-mail:ingrid.goerg-armbrecht@sanofi.com	E-mail: marisol.peron@sanofi.com
Regeneron:
Investor Relations	Media Relations
Michael Aberman, M.D.	Peter Dworkin
Tel: 1 (914) 345-7799	Tel: 1 (914) 345-7640
michael.aberman@regeneron.com	peter.dworkin@regeneron.com

SOURCE Regeneron Pharmaceuticals, Inc.

Asbestos, You And Cancer Risk

Asbestos is the name of a group of minerals with long, thin fibers. It was once used widely as insulation. It also occurs in the environment. Asbestos fibers are so small you can't see them. Disturbing asbestos can cause fibers to float in the air. When this happens, they are easy to inhale. You breathe out most fibers, but some become lodged in the lungs. Over time, they can build up in the lungs, causing scarring and inflammation. This can eventually affect breathing and lead to disease, such as

Asbestosis, or scarring of the lungs that makes it hard to breathe
Mesothelioma, a rare cancer that affects the lining of the lungs or abdomen
Lung cancer
Lung diseases associated with asbestos usually develop over many years. Smoking cigarettes increases the risk.

Exposure to asbestos may increase the risk of asbestosis, other nonmalignant lung and pleural disorders, lung cancer, mesothelioma, and other cancers.
Smokers who are also exposed to asbestos have a greatly increased risk of lung cancer.
Individuals who have been exposed (or suspect they have been exposed) to asbestos on the job, through the environment, or at home through a family contact should inform their physician and report any symptoms.
Government agencies can provide additional information on asbestos exposure.
Learn more at National Cancer Institute in Spanish

Why You Should Get Screened for Prostate Cancer

Prostate cancer screening means looking for cancer before it causes symptoms. This helps to find cancer at an early stage when it may be easier to treat.

Tests that are commonly used to screen for prostate cancer are—

• Digital rectal exam (DRE): A doctor or nurse will insert a gloved, lubricated finger into the rectum to feel the prostate. This allows the examiner to estimate the size of the prostate and feel for any lumps or other abnormalities.
• Prostate specific antigen test (PSA): The PSA test is a blood test that measures the level of PSA in the blood. PSA is a substance made by the prostate. The levels of PSA in the blood can be higher in men who have prostate cancer. The PSA level may also be elevated in other conditions that affect the prostate.

As a rule, the higher the PSA level in the blood, the more likely a prostate problem is present. But many factors, such as age and race, can affect PSA levels. Some prostate glands produce more PSA than others. PSA levels also can be affected by—

• Certain medical procedures.
• Certain medications.
• An enlarged prostate.
• A prostate infection.

Because many factors can affect PSA levels, your doctor is the best person to interpret your PSA test results.

Should I Get Screened for Prostate Cancer?

Not all medical experts agree that screening for prostate cancer will save lives. Currently, there is not enough evidence to decide if the potential benefits of prostate cancer screening outweigh the potential risks.

Potential benefits of prostate cancer screening include—

• Screening can detect cancers early.
• Treatment for prostate cancer may be more effective when it is found early.

Potential risks of prostate cancer screening include—

• False positive test results (indicating that you have prostate cancer when in fact you do not) that lead to further tests and can cause anxiety.
• Treatment of some prostate cancers that may have never affected a man's health even if left untreated.
• Treatment may lead to serious side effects such as impotence (inability to keep an erection) and incontinence (inability to control the flow of urine, resulting in leakage).

CDC and other federal agencies follow the prostate cancer screening guidelines set forth by the U.S. Preventive Services Task Force, which state that there is insufficient evidence to recommend for or against routine screening for prostate cancer using PSA or DRE.

CDC Prostate Cancer information center.

Transforms Cancer Care with Cisco Telepresence, A Webinar.

You have an oppertunity to join a live, immersive one-hour seminar,on how telepresence can transform the treatment of cancer patients. It will be held on June 23 1:00 PM EST. In the this Webinar  Michael Young, Director of Telemedicine at the University of North Carolina Lineberger Comprehensive Cancer Center, will be discussing how Cisco TelePresence is helping to transform the treatment of cancer patients and cancer care.

Learn first-hand how oncologists are using Cisco TelePresence to:

•Review patient cases with top specialists irrespective of
distance or location
•Accelerate discussions about treatment options and facilitate
timely recommendations
•Enable immersive, high-quality consultations

If your organization is looking for a better way to enable clinician collaboration beyond your hospital’s four walls, or you want to learn how oncologists employ video conferencing together with data sharing, this is one session you don’t want to miss. You can register at Cisco by following the link below.
Registration

Eli Lilly's ALMTA Reaches Primary Endpoint In Phase III Study (PARAMOUNT) In Keeping Lung Cancer Alive.

Eli Lilly and company has reached a decisive endpoint in the Phase III ALIMTA study, PARAMOUNT. The study evaluated ALIMTA® (pemetrexed for injection) in the continuation maintenance setting to determine the progression free survival, or the time a patient alive without worsening of the non-small cell lung cancer (NSCLC), a specific type of lung cancer. 

"PARAMOUNT demonstrated that an ALIMTA continuation maintenance regimen—single-agent ALIMTA following ALIMTA plus cisplatin induction therapy—can improve progression-free survival in patients with the most common form of lung cancer," said Allen S. Melemed, M.D., M.B.A., ALIMTA medical product development leader at Lilly Oncology.   "This finding continues to validate the use of ALIMTA maintenance treatment for certain patients living with this devastating disease."   

Here is the Eli Lily Press Release;

Pivotal Phase III ALIMTA study met primary endpoint

INDIANAPOLIS, June 5, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that PARAMOUNT, its Phase III study evaluating ALIMTA® (pemetrexed for injection) in the continuation maintenance setting, met its primary endpoint of progression-free survival, or the time a patient is alive without their disease worsening, for patients with a specific type of lung cancer called advanced nonsquamous non-small cell lung cancer (NSCLC).

"Continuation maintenance" treatment is when one of the same medicines used in first-line treatment setting is continued as maintenance therapy in an effort to control the cancer.  

Results from the study will be presented on Sunday, June 5 at 11:30 a.m. CDT during the Lung Cancer Oral Abstract Session (Abstract #CRA7510) at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Ill.  Lilly will present overall survival results from PARAMOUNT at a medical meeting in the future.

PARAMOUNT is the second study to evaluate the use of ALIMTA as a maintenance therapy in patients with advanced nonsquamous NSCLC, and the first study to evaluate the use of continuation maintenance with ALIMTA(1) following first-line ALIMTA plus cisplatin therapy.

Results of this multicenter, double-blind trial demonstrated the median progression-free survival measured from randomization (after first-line treatment) was 3.9 months on the ALIMTA arm as compared to 2.6 months on the placebo arm with a hazard ratio of 0.64.  Said another way, the study showed that ALIMTA continuation maintenance arm resulted in a 36 percent improvement of survival without disease worsening over the placebo arm. The maintenance disease control rate, or the percentage of patients achieving either a response or stable disease first measured at 6 weeks post-randomization was 71.8 percent (2.8%/69.0%) on the ALIMTA arm and 59.6 percent (0.6%/59.0%) on the placebo arm.  

"PARAMOUNT demonstrated that an ALIMTA continuation maintenance regimen—single-agent ALIMTA following ALIMTA plus cisplatin induction therapy—can improve progression-free survival in patients with the most common form of lung cancer," said Allen S. Melemed, M.D., M.B.A., ALIMTA medical product development leader at Lilly Oncology.   "This finding continues to validate the use of ALIMTA maintenance treatment for certain patients living with this devastating disease."    

A total of 939 patients with advanced nonsquamous NSCLC were enrolled in the study and received ALIMTA (500 mg/m2 on day one of a 21-day cycle) in combination with cisplatin (75 mg/m2) induction therapy.  Patients whose disease had not progressed during the ALIMTA+cisplatin induction and had a performance status of 0-1 (n=439) were randomized to receive ALIMTA maintenance (500 mg/m2 on day one of a 21-day cycle) plus best supportive care (n=359) or placebo plus best supportive care (n=180) until disease progression.  All patients received vitamin B12, folic acid and dexamethasone.

Overall, the most serious (grade 3/4) drug-related adverse events (AEs) were higher for those treated with ALIMTA continuation maintenance versus placebo (9.2% vs. 0.6% laboratory and 8.9% vs. 4.4% non-laboratory). The most commonly reported drug-related AEs observed on the ALIMTA arm versus placebo were anemia (4.2% vs. 0.6%), fatigue (4.5% vs. 0.6%), and neutropenia (3.6% vs. 0%).  There was one potentially drug-related death on each arm. Discontinuations due to AEs were 5.3 percent with ALIMTA and 3.3 percent with placebo.

The study was conducted in patients with advanced nonsquamous NSCLC because past studies have shown that advanced NSCLC patients with a nonsquamous histology (those with adenocarcinoma, large cell carcinoma, or other subtypes) experienced improved efficacy over the relative comparator arm in the trial (an increase in progression-free survival, as well as overall survival), when treated with an ALIMTA regimen.(1,2) Patients with advanced NSCLC with squamous cell histology were not included in the PARAMOUNT study as ALIMTA has not shown to be effective in this patient population relative to the comparators in these previous trials.

About Non-Small Cell Lung Cancer (NSCLC)

Globally, lung cancer is the most common form of cancer and the biggest killer, causing 1.3 million cancer deaths annually.(3)  About 85 — 90 percent of all lung cancers are NSCLC.(4)  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(5), as well histologies classified as "other."

Eli Lily