Cancer PreventionWorks - October 2017

Issue: October 2017

IN THE WORLD OF CANCER

Biosimilars: What are they and what do they mean to cancer patients?

Prevent Cancer Foundation’s Congressional Families Program hosts 25th awards luncheon on Capitol Hill

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PREVENTIVE MEASURES & GENERAL WELLNESS

A new biomarker and new technology bring hope for early detection

(p.6)

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Food and Drug Administration (FDA) to propose new regulations on tobacco products

See, test and treat

Be a healthy employer

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HEALTHY EATING

p.

The beard is back

Pumpkin hummus

p.

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FITNESS

Have fun with fitness this fall STOP CANCER BEFORE IT STARTS! p.

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President’s

Corner

Dear Readers, The weather may be cooling down, but the latest advancements in cancer prevention and early detection are just heating up.

In this issue, we dive into the topic of biosimilars—what they are, and what they mean to cancer patients.

We are also bringing you the latest for oropharyngeal cancer, including newly discovered biomarkers and new technology that may increase early detection for this disease.

If you believe in the mission of the Prevent Cancer Foundation, then I invite you to get involved. Join us at our annual 5k Walk/Run and Health Fair (November 5 at Nationals Park), grow your hair out with NoShave November or make a donation to the Foundation on #GivingTuesday.

Whatever you choose to do, your efforts can help us Stop Cancer Before It Starts!

Thank you for making a difference.

Carolyn Aldigé President & Founder

Prevent Cancer Foundation’s Congressional Families Program hosts 25th awards luncheon on Capitol Hill The Congressional Families Cancer Prevention Program held its 25th Annual Action for Cancer Awareness Awards Luncheon on September 27 in the Library of Congress. The Program’s signature event gathers a bipartisan, bicameral group of supporters to recognize leaders in cancer prevention.

This year’s award recipients exemplify the Program’s mission to educate the public about cancer prevention and were honored for sharing knowledge, providing inspiration and taking action.

PreventCancer.org

FOUNDATION NEWS

Sarah Hospodor-Pallone (spouse of Rep. Frank Pallone, D-NJ) and Marie Royce (spouse of Rep. Ed Royce, R-CA) were each presented with the Congressional Families Leadership Award for their contributions as members of the Congressional Families Program Executive Council.

In addition to creating and steering educational programing, both women have long supported Program and Foundation events.

Laurie McGinley of The Washington Post was honored with the Distinguished Service in Journalism Award for her years of health care reporting, and especially for helping the public to better understand cancer and cancer prevention.

Tom Rinks accepted the Excellence in Cancer Awareness Award on behalf of Sun Bum and Protect The Groms. The innovative sunscreen company was recognized for its outstanding use of social media to inspire sun safe practices, especially in children, teens and young adults. The company’s nonprofit program partners with schools to provide shelter, sunscreen and educational materials to augment its impact.

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IN THE WORLD OF CANCER

Biosimilars: What are they and what do they mean to cancer patients?

By Laura Williamson

The discovery nearly two decades ago of how to sequence the human genome has revolutionized the field of cancer treatment, allowing doctors to genetically profile tumors and treat them with a new wave of medications that either block or circumvent specific gene mutations, substantially slowing or even halting a tumor’s growth.

But these medications – known as biologics – come with a high price tag, costing as much as several thousand dollars a month, or in some cases several hundred thousand dollars per year. In fact, the growth of biologics is largely responsible for the rapidly increasing cost of oncology drugs, which now account for 35 percent of the total cost of treating cancer patients. As patents for biologics begin to expire, however, there is hope that costs can be lowered, or at least kept in check, through the production of biosimilars – drugs that are equally as safe and effective as the original biologics but not entirely identical.

Think generics. What generics are to brand name synthetic drugs, biosimilars are to biologics—“almost,” explains Gary Lyman, MD, MPH, co-director of the Hutchinson Institute for Cancer Outcomes Research and professor of medicine at the University of Washington.

The difference lies in how the drugs are produced. With synthetics, Lyman explained, “you know exactly what elements go into the drug and the structure of that element. It’s relatively simple to use the same cookbook to create another chemical agent in the lab. If it’s done properly, it’s exactly the same as the original compound. But for biologics, it’s far more complicated. These are very large molecules that are produced in living organisms, in cells.

Their complex structure cannot be exactly replicated because it’s impossible to replicate the living conditions of a cell.”

To ensure the drugs are as similar as possible, the Food and Drug Administration (FDA) requires that manufacturers conduct analytical studies, preclinical testing and clinical trials, including a comparative design study that demonstrates the biosimilar is as safe, pure and potent as the biologic, known as the originator or reference product. But testing for biosimilars is not as extensive as it is for the drugs they seek to replicate.

“If you required the same amount of clinical trials for biosimilars as you do for the originator biologics, then the cost would be at least as high,” said Lyman.

“While considerable preclinical work is still required, there may be just one study to see how the biosimilar behaves in humans, as opposed to many.”

The abbreviated path to FDA approval was created under the Affordable Care Act, which recognized the need to contain development costs. Given the limited amount of clinical evidence that exists prior to the drug’s approval, said Lyman, the FDA may also require that a biosimilar be tracked once it’s on the market to ensure there are no rare or delayed side effects.

“Although biosimilars have their own unique approval pathway with the FDA, that does not mean biosimilars are any less safe than the originator molecules,” said Christopher Herrem, Medical Director for Mylan, which has two biosimilar oncology medications currently under review and others in development. “The amount of analytical work done in the laboratory is extensive.”

So extensive, in fact, that while biosimilars are expected to lower prices, it’s unlikely they will do so dramatically. It takes up to $250 million and about 8 years to bring a single biosimilar to market, compared to $1-5 million and 3-5 years to bring a generic version of a synthetic drug to market. Historically, generics have resulted in a 60-80 percent drop in price compared to brand name synthetic drugs.

PreventCancer.org

Biosimilars, in contrast, are expected to bring “at most a 20 percent drop in pricing” compared to the originator biologics, said Lyman.

While this is not a dramatic drop, the reduced cost of biosimilars can make treatment more economical for patients experiencing high prescription costs.

“They are less

expensive to

develop,but they are certainly

not cheap,”

Lyman said.

For example, Zarxio

(filgrastim-sndz),

the first biosimilar

approved for sale in the

United States, was 15

percent

cheaper ($438.98

for a 480 mcg syringe) when

it hit the

market than Neupogen

($516.45 for

the same

dose), its

reference

product. Zarxio was given the

green light by the FDA in 2015

and is used to reduce the toxicity

of chemotherapy by stimulating white blood cells to prevent infections.

At least two more oncology biosimilars may gain FDA approval by the end of the year.

A decision is expected to come soon on pegfilgrastim (Neulasta), which is a longer-acting form of filgrastim, used to ward off infections during chemotherapy by boosting the production of neutrophils, a type of white blood cell. A decision is expected in December on Trastuzumab, biosimilar to the drug Herceptin, which functions “like a smart bomb for breast cancer,” said Herrem, searching for cells that express certain molecules and binding to them, inhibiting tumor growth.

IN THE WORLD OF CANCER

The FDA just recently approved a biosimilar for Avastin (bevacizumab), which interferes with the growth and spread of cancer cells and is prescribed for certain types of brain tumors and cancers of the kidney, lung, colon, rectum, cervix, ovary and fallopian tube.

While biosimilars are relatively new to the U.S. market, they have been available in Europe since 2007. There are currently 35 biosimilars authorized in the EU, 15 of which are used to treat cancer while others are used in the treatment of conditions such as rheumatoid arthritis, diabetes, psoriasis and anemia. Both the U.S. and European markets are expected to expand greatly over the next five years, as patents for biologics begin to expire.

Oncologists who may be hesitant to accept biosimilars can look to the EU for assurance, noted Lyman.

“Part of what is happening in the U.S. is we are learning from the experience of the Europeans,” he said. “They have found very few problems with biosimilars in a large number of patients who have been treated and that’s reassuring that we probably won’t see major problems here.”

Thus far, biologics (and biosimilars) have been restricted to the treatment of cancers already diagnosed and supportive therapies for people undergoing treatment. But Lyman remains hopeful they’ll ultimately play a role in prevention and early detection.

“I think there’s no question that there will be biologics and biosimilars that are preventive agents and not just therapies,” he said. “If not for primary prevention, they soon will be developed for [tertiary] prevention, that is, allowing us to prevent cancer from returning to a person previously diagnosed and treated.”

"Although biosimilars have their own unique approval pathway with the FDA, that does not mean biosimilars are any less safe than the originator molecules"

-Christopher Herrem

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IN THE WORLD OF CANCER A new biomarker and new technology bring hope for early detection 6

An early biomarker of oropharyngeal cancer, combined with new technology, may be the key to increased early detection of the disease.

Oropharyngeal cancer (cancer of the back of the throat, including the base of the tongue and the tonsils) is notoriously difficult to diagnose early, but a biomarker discovered by Aimee Kreimer and Tim Waterboer has the potential to change this.

That’s big news for a disease that’s becoming increasingly common, especially in men. In fact, new cases of oropharyngeal cancers have surpassed those of cervical cancer in women since 2010.

The majority of these cases (about 75 percent) are caused by the human papillomavirus (HPV).

The biomarker, an antibody directed against the HPV16 E6 oncoprotein, is appearing in 90-94 percent of oropharyngeal cancer patients, and a study shows it appears more than 10 years prior to cancer diagnosis. But one of the challenges is that even when tumors are symptomatic, it can be very difficult to find primary tumors and lesions on the oropharynx.

“Oftentimes, patients will come in with a very obvious neck node,” said Dr. Krystle Kuhs, who specializes in virus-associated cancers. “But then we can’t find the primary tumor on the tonsils or the base of the tongue. If we can’t find it when they’re symptomatic, how can we find it early?”

By collaborating with Dr. Carole Fakhry, Dr. Kuhs may have found an answer. Dr. Fakhry, along with her team at Johns Hopkins, pioneered a new ultrasound technique to detect tumors that MRIs and CT scans failed to find.

She uses a miniaturized ultrasound machine, which is comprised of a small ultrasound phone that connects to a tablet. The entire “machine” can fit inside a purse, and according to Dr. Kuhs, there is no difference in efficacy between this miniature ultrasound and a full-size machine.

Now, Dr. Kuhs and her team at Vanderbilt are putting Dr. Fakhry’s technology to use. In August, they enrolled the first patients in a study using the miniature ultrasound on patients with suspected oropharyngeal cancer. They are testing to see if they can find tumors with the miniature ultrasound, and are also doing a blood draw to validate the finding that nearly 100 percent of oropharyngeal

cancer patients have the antibody biomarker present at the time of diagnosis.

If the study is successful, Dr. Kuhs says they can move on to testing

the theory in healthy patients. That means that they can test for the

antibody/biomarker in patients with no symptoms, and if the

antibody is present, bring them in for a full head and neck exam.

Though still in the early stages, this project has the potential

to increase early detection of oropharyngeal cancer. And then?

“The potential is limitless,”

Dr. Kuhs said.

PREVENTIVE MEASURES & GENERAL WELLNESS See, test and treat

PreventCancer.org

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The Appalachian region has the highest cancer mortality rate in the U.S. This can be attributed to many factors, including lack of education and limited access to medical care.

In an effort to address these disparities, the Prevent Cancer Foundation’s Think About the Link campaign partnered with the College of American Pathologists (CAP) Foundation to host a See, Test, Treat cancer screening and education program at Norton Community Hospital in Southwest Virginia.

Women traveled from across five counties spanning more than 2200 square miles to receive high-quality medical care that can be hard to come by in this region. Others even traveled from neighboring states to receive medical care not available to them. Health care providers administered close to 350 medical services, which for some was the only medical treatment they would receive all year.

Services included free breast and cervical cancer screenings for women, as well as HPV testing, bone density screenings, flu shots and health education. Think About the Link offered patients an engaging educational experience about the human papillomavirus (HPV) and its link to at least six types of cancer.

Patients received same-day test results and follow-up treatment when deemed necessary—at no cost to them. Of the 44 women who received Pap tests at the event, one-third received an abnormal test result and were linked to follow-up treatment within days.

Be a healthy employer

The workplace can take a big toll on your employees’ health―they may spend too many hours sitting at a desk or feel pressure to avoid taking time for doctors’ appointments. While gym memberships and weight loss programs can strain your budget, there are easy and cheap ways to promote health in the office.

Doctor visit policy

Create a policy where employees can take time off to visit the doctor without it counting against their vacation or sick days. This policy encourages wellness visits

that could ward off

potentially bigger

health problems

down the road,

and you’ll win

out if your

employees avoid

long illnesses.

Walking meetings

Stock healthy foods

If your office break room is full of sugary sodas, processed chips and candy, switch them out for healthy snacks. When your

employees hit the

afternoon slump,

they’ll feel more

focused with

nutrient-rich

foods like nuts,

fruits, yogurt,

trail mix and nut butters.

Making small changes at your company can have a big impact on preventing cancer and creating a culture of health. For more information on how a healthy lifestyle can reduce cancer risk,

visit preventcancer.org.

Encouraging employees to hold walking meetings, which increase their daily activity as well as their focus and concentration. Your team will enjoy the change

of scenery and

walking will help

everyone feel

more energized

and creative.

ADVOCACY NEWS Food and Drug Administration (FDA) to propose new regulations on tobacco products

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As part of its efforts to decrease smoking rates among children and adolescents, the FDA plans to lower the amount of nicotine in cigarettes to a level that will help curb addiction.

An estimated 90 percent of adult smokers start before the age of 18.

This is the first time in FDA history it has sought to regulate the amount of nicotine in cigarettes. The plan is part of a broader effort to lay a scientific framework that will help better regulate cigarettes and other tobacco products. The agency will also begin regulating electronic nicotine delivery systems (ENDS), also known as e-cigarettes. The FDA will be reviewing these products, looking specifically at the impact of liquid nicotine and flavored tobacco, to provide guidance on any public health concerns.

To give itself more time to review combustible tobacco and ENDS products, the FDA will not issue new regulations until 2021 and 2022—an extension of the deadline for product review applications originally scheduled for August 8, 2016.

“The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes—the only legal consumer product that, when used as intended, will kill half of all long-term users,” said FDA Commissioner Scott Gottlieb. “Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use.”

Though the Prevent Cancer Foundation does not endorse the use of tobacco in any form, we applaud the FDA’s plan to lower nicotine levels in cancer-causing cigarettes, while also taking steps to investigate the impact of ENDS and combustible tobacco products on children and adolescents.

The beard is back

Our favorite time of year is almost here: No-Shave November! For the third consecutive year, the Prevent Cancer Foundation will be an organization benefitting from this month-long campaign to raise awareness and funding for cancer prevention, research and education.

Ditch your razor for the month of November and #LetItGrow—then donate the cost of grooming to the cause. Many also solicit donations from family and friends. You’ll be surprised by how many people ask you about your new look, which is the perfect opportunity to talk to them about making healthy lifestyle choices to reduce cancer risk.

See our home page for more details: PreventCancer.org

PreventCancer.org

Pumpkin Hummus

HEALTHY EATING

The pumpkin craze is here to stay, but fortunately this seasonal gourd offers health benefits.

Research shows that people with diets rich in foods containing beta-carotene (the source of pumpkin’s orange color) may have lower risk of certain cancers like lung and prostate.

Adding pumpkin to hummus is a great way to up the flavor and nutritional value of an already wholesome snack.

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MAKE A DIFFERENCE

It’s not quite time to talk turkey and sides, but check out what’s coming up in November…

#GivingTuesday, the Tuesday following Cyber Monday, is a global giving movement built by communities in all 50 states and countries around the world.

This year #GivingTuesday falls on Tuesday, November 28, 2017.

How often do you give? Generosity comes in all forms.

Join the worldwide movement. Transform the holiday season.

Help us

Your monthly gift can save a life

Do you know someone touched by cancer?

Are you a cancer survivor?

Have you lost a loved one to cancer?

If yes, you know the devastating feelings from a cancer diagnosis.

There is hope! You can help to

Stop Cancer Before It Starts!

By setting up a monthly recurring gift to the Prevent Cancer Foundation, your dollars guarantee a spotlight on cancer prevention and early detection.

You can save lives today and future generations to come.

Join the Cancer Preventers Recurring Gift Program! Your recurring gift is a simple and efficient way to show you care about the cause while helping sustain our programs.

Contact Christina Falck Armstrong for more information. christina.armstrong@preventcancer.org or 703-837-3684

Be a hero today!

http://preventcancer.org/give

PreventCancer.org

Have fun with fitness this fall

FITNESS

11

There’s a lot to look forward to when summer turns to fall―what’s not to love about the changing leaves, the return of football and pumpkin spice everything? Even though the weather is getting cooler, fall is perfect for outdoor activities to keep you moving. Staying active is a key step to reducing your cancer risk, so take advantage of all this season has to offer while burning calories.

Apple picking

Fall is apple season, so head to a local farm or orchard for a fun day picking your own apples. Apple picking gets the whole family walking around outside and stretching for the perfect apples, plus you’ll leave with a healthy snack.

Corn mazes

Lots of farms put together corn mazes this time of year for a fun activity that keeps you moving. There’s also added camaraderie as you and your family or friends work together to find your way out.

Haunted trails and ghost tours

If you love a good spook, look for haunted houses and trails that keep you moving. Bonus points if a creature scares you enough to break into a run! For a less scary Halloweenthemed activity, learn about your town’s spooky history on a walking ghost tour. Check out your town’s Visitor Center online for more information on local tours.

Pumpkin spice prevention

TO SUBSCRIBE, CONTACT: Prevent Cancer Foundation 1600 Duke Street, Suite 500, Alexandria, VA 22314 Toll-Free: (800) 227-2732 Main: (703) 836-4412 Email: pcf@PreventCancer.org Visit: PreventCancer.org Cancer PreventionWorks is published by the Prevent Cancer Foundation, a 501(c)3 nonprofit organization dedicated to the prevention and early detection of cancer.

All contributions are tax deductible to the fullest extent allowed by law. The Prevent Cancer Foundation is a member of the Combined Federal Campaign (#11074).

1600 Duke Street, Suite 500, Alexandria, VA 22314

Politics and prevention Biosimilars: What are they and what do they mean to cancer patients?

A new biomarker and new technology bring hope Giving for early Tuesday detection 11.28.2017