Approval of Keytruda in Europe for first-line use with chemotherapy in lung cancer strengthens the use of PD-1 inhibitors as backbone therapy, says GlobalData

Following FDA approval in August, this week (wk comm 10^th Sept) the European Commission (EC) also approved Merck Sharp & Dohme (MSD)'s PD-1 blocking antibody, Keytruda (pembrolizumab), for use as a first-line therapy in combination with Eli Lilly’s Alimta (pemetrexed) plus platinum chemotherapy, for patients with metastatic non-small cell lung cancer (NSCLC) who have no EGFR or ALK positive mutations.

Keytruda is a recombinant monoclonal antibody that is already approved for a number of cancer types in Europe, including metastatic melanoma, classical Hodgkin lymphoma, urothelial carcinoma, and as a single agent for the treatment of patients with metastatic NSCLC whose tumors have high PD-1 ligand (PD-1L) expression. Keytruda acts by blocking the interaction of PD-1 with its ligand (PD-L1), releasing PD-1 pathway-mediated inhibition of the immune response and thereby activating T-cell immune surveillance of tumor cells.

According to GlobalData’s report, 'PharmaFocus: Visual Analysis of Immuno-Oncology Development and Opportunities' , among the checkpoint modulators, antibodies targeting PD-1 and PD-L1 [PD-(L)1] account for more than half of clinical trials and have experienced exponential growth since 2015.

GlobalData expects that this trend will continue in the coming year as PD-(L)1 inhibitors are being explored in new cancers, such as pancreatic cancer, hepatocellular carcinoma, and acute myeloid leukemia. Furthermore, marketed PD-(L)1 inhibitors are moving into earlier lines of treatment and are increasingly explored in combination trials utilizing PD-(L)1 as a backbone therapy for existing or innovative therapeutic strategies.

Dr Edit Kovalcsik, Managing Analyst at GlobalData, commented, “Lung cancer is one of the most common cancers and NSCLC makes up approximately 85% of all lung cancers. Therefore NSCLC covers the most lucrative field in the lung cancer space.”

GlobalData’s report, ‘Non-Small Cell Lung Cancer (NSCLC) - Dynamic Market Forecast to 2025’, reveals that approximately 177 thousand cases were diagnosed with NSCLC in 2017 in the five European markets – France, Germany, Italy, Spain and the UK. The report also forecasts that Merck’s Keytruda will become the lead therapy in NSCLC with forecasted global sales across the 8MM (US, 5EU, Japan and China) of USD $3bn by 2025.

IMAGE FOR PUBLICATION: Please click here for chart: Forecasted 8MM Sales of Top Immunotherapy Drugs in NSCLC, 2015-2025

The EC’s decision of approval of Keytruda-chemo cocktail was based on the KEYNOTE-189 trial, in which the combination therapy reduced the risk of death by half, compared with Alimta and chemotherapy (cisplatin or carboplatin) alone. In addition, the Keytruda combination significantly improved the progression-free survival (PFS) compared with Alimta and chemotherapy alone.

Roche’s Tecentriq and Bristol-Myers Squibb’s Opdivo are direct competitors to Keytruda. Keytruda’s approval in the first line setting combined with chemotherapy comes as a blow for Roche as last week the FDA delayed its decision on the use of Tecentriq in combination with Avastin and chemotherapy in the frontline setting for metastatic NSCLC by three months. BMS’ Opdivo plus Yervoy combination could also challenge Merck’s Keytruda combination in the frontline NSCLC, as the FDA accepted BMS’ application in June 2018 to market the immuno-oncology combination, based on the improved PFS demonstrated in the CheckMate-227 trial.

Kovalcsik concluded, ‘‘Approval of Keytruda-chemo combination therapy paves the way for the frontline use of PD-(L)1 combination therapies in the NSCLC space.”

GlobalData.com | LinkedIn | Twitter

About GlobalData

4,000 of the world’s largest companies, including over 70% of FTSE 100 and 60% of Fortune 100 companies, make more timely and better business decisions thanks to GlobalData’s unique data, expert analysis and innovative solutions, all in one platform. GlobalData’s mission is to help our clients decode the future to be more successful and innovative across a range of industries, including the healthcare, consumer, retail, financial, technology and professional services sectors. PR2744

With Alzheimer’s treatment stalled, promising pipeline drugs and a shift in perception could be key to tackling the disease, says GlobalData

As World Alzheimer’s Day approaches (21 September) with the aim of raising global awareness and understanding of the issues faced by people affected by dementia it’s timely to reflect that no new drug for Alzheimer’s disease (AD) has been approved in the past 16 years, despite more than 400 clinical trials and billions of dollars being spent in an attempt to tackle the disease and address unmet needs, says GlobalData a leading data and analytics company.

According to GlobalData’s latest report, ‘Alzheimer’s Disease: Competitive Landscape to 2026’, the pipeline has been characterized by big failures, as AD drug development is considered to have one of the highest failure rates of all indications. The AD pipeline features 657 drugs across all stages of development, and out of these, only 3.2% of drugs are in late stage development; which is dominated by small molecules and monoclonal antibodies. The report reveals that Amyloid precursor protein (Aβ peptide and protein) and microtubule associated protein tau (MAPT) are the major targets being pursued by companies developing drugs against AD.

Alessio Brunello, Pharma Analyst at GlobalData, commented, ‘‘The need for new disease modifying drugs (DMDs) is urgent as the current competitive landscape in AD offers medications that are aimed at treating only the symptoms of the disease. A few key drugmakers have already stopped their research into AD, and given the significant amount of R&D failures, pharma companies may be disincentivized from producing new drugs. The amyloid hypothesis has been the central theory for the pathogenesis of AD, but all Aβ-targeting drugs treating AD have ended in failure. In fact, recent studies indicated that one of the main factors concerning the development and progression of the disease could be tau and not beta amyloid. We may, in the future, see tailored therapies to include potentially both an anti-amyloid and an anti-tau approach being administered concurrently.”

Currently, treatments for AD consist only of symptomatic treatments, of which there are only five approved medications: three cholinesterase inhibitors (ChEIs) (donepezil, rivastigmine, and galantamine), one N-methyl-D-aspartate receptor (NMDA-R) antagonist (memantine), and one combination therapy (memantine/donepezil). These leave a lot to be desired in terms of efficacy, routes of administration, and dosing frequencies.

The potential launch of promising monoclonal antibodies from Biogen (aducanumab) and Roche (gantenerumab and crenezumab) will boost the size of the Alzheimer’s market given their potential to halt or prevent disease progression. Most of the tau-targeting approaches that are currently in clinical trials are immunotherapies such as Axon neuroscience’s AADvac-1 and Eli Lilly’s LY3303560. Tau is more likely to be a better target than Aβ as the clinical stages of cognitive decline much better correlate with the number, density and distribution of tangles than does the Aβ burden.

Brunello concludes, ‘‘Monoclonal antibodies have shown more promise than anything in the pipeline and in the next 10 years, we're going to have a good idea on whether amyloid is really a meaningful player or not. The industry shifted a little to anti-tau therapies, showing that tau treatments represent a new direction with a possible combination approach if trials will provide positive results. In the absence of any proven disease-modifying therapy, if and when one will reach the market, the rewards in term of profits for the developer would be huge.”

About GlobalData
4,000 of the world’s largest companies, including over 70% of FTSE 100 and 60% of Fortune 100 companies, make more timely and better business decisions thanks to GlobalData’s unique data, expert analysis and innovative solutions, all in one platform. GlobalData’s mission is to help our clients decode the future to be more successful and innovative across a range of industries, including the healthcare, consumer, retail, financial, technology and professional services sectors. PR2669

WHY GOING COLD TURKEY FROM ALCOHOL CAN KILL YOU

www.beachway.com

One out of every 12 adults in the United States suffers from alcohol dependence, making alcohol the most regularly used addictive substance in America, the National Council on Alcoholism and Drug Dependence (NCADD) reports. Drinking large amounts of alcohol regularly can cause the brain to get used to the way that alcohol interferes with neurotransmitter transmission, movement, and absorption. If you’re a heavy drinker, abruptly quitting alcohol without the help of medical professionals — known as going “cold turkey” — can be painful and dangerous. Carrie Carlton, Clinical Director (LCSW)  of Beachway Therapy Center in Boynton Beach, Florida gives the lowdown on what you should know if you’re considering detoxing from alcohol on your own and why you might want to consider an in-patient medical detox.

According to Carrie Carlton LCSW, “When someone who has become "alcohol dependent" decides to stop drinking, he/she will experience some level of physical discomfort. For this reason, it is extremely difficult for a person to merely stop drinking "on their own" without assistance and support.”

What are the Dangers and Symptoms When Someone Stops Cold Turkey

Common symptoms include:

Depression

Anxiety

Headache

Fatigue

Nausea and vomiting

Nightmares

Shakiness

Fever

Irritability

Delirium Tremens

Getting the Shakes

For those who are less chemically dependent, withdrawal symptoms might be as "mild" as merely getting the shakes, or the sweats—or perhaps nausea, headache, anxiety, a rapid heartbeat, and increased blood pressure. Although these symptoms are uncomfortable and irritating, they are not necessarily dangerous. But they are often accompanied by "craving" more alcohol, making the decision to continue abstinence much more difficult to make. Even the "morning after" hangover of someone who only occasionally drinks to excess is actually a mild form of alcohol withdrawal from the excesses of the night before, as the alcohol content of their blood begins to drop. The symptoms can appear within a few hours after not drinking.

The Full-Blown DTs

Within six to 48 hours after not drinking, hallucinations may develop. These usually are visual hallucinations but they can also involve sounds and smells. They can last for a few hours up to weeks at a time. Also, within this time frame after quitting, convulsions or seizures can occur, which is the point at which alcohol withdrawal can become dangerous if not medically treated. The symptoms may progress to delirium tremens (DTs) after three to five days without alcohol. The symptoms of DTs include profound confusion, disorientation, hallucinations, hyperactivity, and extreme cardiovascular disturbances. Once DTs begin, they can cause cardiac disturbances, seizures and other medical complications that can be fatal.

Alcohol Withdrawal Timeline

First 12 hours     Heavy drinkers experience tremors a few hours after their last drink. Symptoms during the first 12 hours include sweating, irritability, rapid heartbeat, high blood pressure, nausea, vomiting and insomnia.

Days 1-2    Symptoms peak 24 to 48 hours after the last drink. Symptoms are most severe and may include seizures, night terrors, hallucinations and panic attacks.

Days 3-5    Ongoing feelings of nervousness, shakiness and mood swings can last up to a week after the last drink. Delirium tremens may occur during this time as well.

Days 6+      After detox, some former heavy drinkers experience longer-lasting effects of withdrawal. Symptoms are mostly psychological. They may include mood swings, anxiety, irritability, changing levels of energy and trouble sleeping. These symptoms come in waves and can last for months after the last drink.

What can a medical detox do that going it alone cannot achieve?

Medications Used During Alcohol Detox

When alcohol detox is treated in an inpatient rehab facility, different medications may be used to help reduce uncomfortable withdrawal symptoms. Medications can also help keep a person’s body chemicals in balance, lowering the risk for serious complications. In rehab, a medical professional will administer the medication and monitor its effects. If the medication begins to cause unwanted side effects or interferes with the detox process, another remedy can be used. Typically, vital signs are checked every few hours as well as body temperature.  Patients are often given anti-seizure medication and benzodiazepines such as valium to make the withdrawal more physically tolerable.  An in-house detox also makes things psychologically easier for the patient, as they are around other clients who are going through the same experience.

Several medications commonly administered during the detox phase are:

Benzodiazepines

Benzodiazepines (benzos) are most frequently used to treat withdrawal symptoms during the alcohol detox phase. They are used to help calm your central nervous system and may also be prescribed to treat insomnia, anxiety and muscle spasms.

Naltrexone

Naltrexone helps reduce alcohol cravings during the detox stage. In the event of a relapse, naltrexone works by inhibiting the high feeling that alcohol may cause. Since the medication can stimulate withdrawal symptoms, it is recommended that you wait seven to 10 days before taking naltrexone.

Acamprosate

Years of heavy drinking can significantly alter how the brain looks and works. Acamprosate, sold under the name Campral, is prescribed to help your brain begin to function normally again after you quit drinking. Research studies have also started to look into whether or not acamprosate helps reduce the symptoms of PAWS including insomnia, anxiety and restlessness. It also works to reduce alcohol cravings; however, it will not produce an unwanted effect if alcohol is consumed.

Disulfiram

Another medication used in the treatment of alcoholism is disulfiram. Unlike other medications, disulfiram works by producing severe reactions if alcohol is consumed. For instance, if you drink while on disulfiram, you will experience unwanted effects like facial flushing, nausea, headache, weakness and low blood pressure. The negative effects are meant to deter you from continuing your drinking pattern. Disulfiram is not meant to reduce your alcohol cravings or restore brain functions like some other medications.

What should patients do after treatment at a detox facility?

Beachway Therapy provides detox treatment and also residential treatment programs at another site, that entails a minimum stay of 30 days and can be more.  Once the physical detox is over, it is here that patients learn the long term tools to stay sober.  In addition, a continuing outpatient plan of care is established for each patient prior to leaving treatment.

About Beachway Therapy Center

At Beachway we understand that there may not be a second chance at recovery so we strive to be the last treatment program you will need.  By providing a continuum of care, from PHP (Partial Hospitalization Program) to Outpatient services, we can offer a fully individualized treatment plan that meets the clinical and medical needs of each client. Length of stay will vary for each client, most of our clients stay between 30 and 90 days, determined on an individualized basis.  By providing an extremely low client to therapist ratio we can identify and address underlying, co-occuring disorders.  Under such professional supervision clients can begin to recover in a safe, residential-like environment.  Some of the Therapeutic Methods that we use at Beachway are:

Our multidisciplinary team of credentialed and veteran staff utilize the latest evidence-based practices in medical, psychiatric and addiction treatment, including CBT (cognitive behavioral therapy) motivational interviewing, addiction counseling, 12-Step orientation, DBT (dialectical behavioral therapy,) trauma informed practices and a wide variety of supportive group therapies.

Carrie Carlton, Clinical Director (LCSW)

Carrie is the Clinical Supervisor at Beachway and holds a BSW and MSW in social work from Florida Atlantic University, a MA from Barry University (Miami), and is a Licensed Clinical Social Worker. She also has a background in medical social work. Her understanding of cognitive behavioral therapy, solution focused therapy, and family systems guides her treatment of addicts and families. Her clients thrive under her guidance because of her honesty, empathy, and compassion. Recognizing the severe impact of addictions on both the addict and the families, Carrie is dedicated to consistently

Canadian public engagement platform Carrot Rewards ranks Top 20 on the Canadian Business and Maclean's 2018 Startup 50

Innomane Inc. Announces Health Canada Approval and Canadian Launch of Diaronex®, an Over-The-Counter Herbal Remedy to Help Relieve Diarrhea

Gripping Memoir Details Life Before And After Debilitating Stroke

Trevose, PA, September 12, 2018 ― For Mary Reid-Hill, the word "no” means surrender. It means life on the couch. It means dying a slow death. So never tell Mary that she can't do something. Because she'll do everything in her power to prove you wrong.

Mary entered "adulthood” with a load of problems to unpack, including a twisted, abusive childhood; a misguided teen marriage; and a cancer diagnosis at the tender age of 22. Somehow, in spite of it all, she used her skills as a visual artist to carve out a career in the male-dominated world of sign design and installation.

But life wasn't done testing her. At age 38, at the peak of her success, she suffered a major stroke which left her with essentially half her brain and body capacity. For more than 15 years, she has defied doctors, therapists, and even friends and family to stubbornly and relentlessly find her own equilibrium and happiness, "in spite of” all of her health challenges, psychological roadblocks and spiritual upheaval.

But that's just Mary.

And now, she's sharing her remarkable story in her inspirational memoir, In Spite Of . . . How I Survived Abuse, Cancer, and a Giant F@#%ing Stroke, as told to David Tabatsky—author, co-author and/or editor of more than thirty books, covering a vast range of subjects. For more information on David, please visit his website at: www.tabatsky.com.

Mary's approach is refreshingly candid and infused with humor as she chronicles a series of life events that would emotionally cripple most people, including her messed- up childhood, two bad marriages, the devastating stroke, her battles with weight and insurance companies, and the death of her husband. Through it all, her no-nonsense prose underscores why she's become a living example of what the human spirit is ultimately all about and how, in spite of it all, she's still here.

Mary was born and raised in Bucks County, Pennsylvania, and still lives there today, on the corner of Hope and Humor. For the past 17 years, Mary has been unable to hold down a job, due to a disability stemming from her stroke. However, she remains as active as possible, renovating her home, refinishing furniture and continuing her main passion––drawing. Her memoir includes 15 original drawings, some of which she created before the stroke, and several after, when she had to teach herself to draw all over again, this time with her left hand. On top of that, Mary cares for two dogs and occasionally her two closest sisters.

For more information, please visit the website at: www.inspiteof.life.

In Spite Of . . . How I Survived Abuse, Cancer, and a Giant F@#%ing Stroke
Legacy Projects
Release Date: August 2018
ISBN–13: 978-1722983352
ISBN–10: 1722983353

How 46-Year-Old Jeffrey Bird Overcame the Brink of Death by Changing His Diet

Former business man, turned personal trainer and pulmonary embolisms survivor, Jeff Bird, reveals how he lost a staggering 66lbs in just 6 months, despite going through personal hardships and a deep vein thrombosis diagnosis that had significantly impacted on his lifestyle and self-esteem. Mr Bird was able to shed weight by following a simple, clean eating dieting plan, combined with hard work and persistence after a sudden life re-evaluation.

The fitness trainer has now not only transformed his body, but also has a new lease on life. Mr Bird has expressed his past frustration towards his body image and thanks to a balanced eating program has changed his outlook completely, by allowing him to combat excess weight gained from years of taking antidepressants and medical treatments that he had endured over many years. He was able to bring his weight down from 282lbs to 191lbs in a relatively short amount of time.

“Through ‘life’ happening, I ended up with major depression that had lasted for many years. I would genuinely feel nothing, which would impact me on so many levels. I would just randomly start crying at home and often felt numb and disengaged throughout the day. It was a hard and never-ending period in my life, where I believed I was just existing for the sake of it. After getting my DVT’s and lung pulmonary embolisms diagnosis, I thought this is not going to be the end of me”, Bird says.

With a controlled meal plan, from 123Diet, Mr Bird says staying focused and ultimately not wanting to be the person he was any longer helped him to achieve his weight loss goals. He notes how having the support of 123Diet’s online community encouraged him to make a change for the better, in addition to a few online connections inspired him to actively work out.

“One night, I came across the 123Diet program and it’s online community through my Facebook newsfeed. I would frequently read other people’s stories, learning what they did and how it had affected them and changed their perspective completely after finishing the program. I had watched and followed the site rather sceptically for 6 weeks until I mustered up the confidence to give the product a go”.

Mr Bird thanks his change to the work of 123Diet, hard work and determination for his new and healthy lifestyle and outlook on life.

“Over my Journey so far, there have be ups and downs. There have been times where I wanted to stop due to whatever the reason was, but I knew I didn't want to be the person I had been for the past 42 years (at the time). I vowed to myself that I was not going to live the next 42 the same way”, he said.

“You don't have to be the person you have been for so long or stuck in the negative place you may be now...You can change and you can overcome anything you set your mind to…but only if you’re determined to make that change. I realised at such a later time in my life, but its advice that I pass onto everyone else now, it’s your time, it's your life, please make it count. Don’t be afraid to create the new, happier you, become the best version of yourself there has ever been”.

For more information about 123Diet, please visit: www.123diet.com.au

Toronto woman on a mission to prove strong is the new sexy 

Hey guys! As you know I only recommend products that I have tried and truly believe in. And I can definitely say DNAPower is a great gene testing kit.

I was recently sent a DNA testing kit from DNAPower. The test was really simple and I sent it back promptly. They were great at letting me know the status of the test at all times until the results were finished. I had the TotalPower test. This is the full test kit.

TotalPower DNA testing includes:

• dietPower
• fitPower
• brainPower
• detoxPower
• hormonePower
• InflamPower
• MethyPower 

According to their site you "learn all you can about your genetic makeup so you can take action to be the healthiest you can be. Know how your body works and personalize your fitness routine and nutrition in a way that will maximize your health. This fully comprehensive package will provide you with actionable health guidance based on the relationship between nutrition, lifestyle and your genes to achieve lifelong gains in your health and wellness."

“With the information learned in the totalPower test, we were able to come up with a health and fitness plan that would be the most effective for my body. What a difference. It’s like having the blueprints to your foundation and knowing where your strengths and weaknesses are. ~ Daniele”

Easy To Understand Results

Each report provides a summary of the health area included, the significance of those areas, the key gene(s) tested, and tips to take Power over your Health.

Once I received my results I had a loo myself. Since I have a Kinesiology background and vast experience through training clients of reading reports I fully understood about 75% of the information. Some of it I did not as it is related to my genes. But it is safe to say that the results were the best out of any DNA test that I have done (I have done 2 others). It was so detailed and really relevant to my preps. Full of information that I will be implementing. On top of this they did a phone call with me explaining the results and if I had any questions. We went over each test and it took about an hour.

The three things that I took away from the report were that I did to supplement with complex B vitamins for inflammation more, I process carbohydrates well which is good to know (especially for my preps) and I should also supplement Omegas more because my body does. not processes them well. So if I take more it will have a better effect. All of these things are great to know for my competition preps and I find it very valuable. I cannot thank DNAPower enough for this test as I will implement these things immediately into my supplementation.