Future of Cancer Care

MARCH 2020 | FUTUREOFPERSONALHEALTH.COM

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FUTURE OF CANCER CARE

Fran Drescher

The star of “The Nanny” is leading the Cancer Schmancer movement

St. Luke’s University Health Network encourages early colon cancer screening

Learn about the gold standard of skin cancer treatments

READ ON

The foundation that’s helping cancer survivors thrive Page 4

Combining resources in the fight against pancreatic cancer Page 10

A football coach overcame cancer with the support of his team Page 13

The Future of Cancer Care Is Bright In recent decades, we have seen great progress in treatment and management of cancer, though there is still more work to do.

The future has never been more promising for people living with cancer.

The first two decades of the 21st century ushered in a revolution in our understanding of cancer, generating precise and targeted treatments while also dramatically improving quality of life for patients.

My organization, the American Society of Clinical Oncology (ASCO), recently outlined the top cancer achievements over the past year in its

Howard A. “Skip” Burris III FACP, FASCO, President, American Society of Clinical Oncology

investigational drug that is now widely used to treat breast cancer.

Here we were, joyfully celebrating with her now-married daughters, their husbands, and three beautiful grandchildren.

Such is the importance of clinical trials and promising new therapies.

of cancer research. Just last year, I attended the 65th birthday party of a current patient. She had been diagnosed 10 years earlier with metastatic breast cancer and hadn’t been sure she wanted to move forward with further treatment. With encouragement, she elected to participate in a clinical trial of an

The road ahead Stories like this one are becoming more frequent, yet there is still work to do.

We need to join together to ensure all patients live longer and live better. This is no small task and will require the efforts and expertise of physicians, nurses, patients, industry, government, academia, and more. I firmly believe

annual Clinical Cancer Advances report.

Medical advances The refinement of surgical approaches to cancer is specifically highlighted.

Incorporating new therapies has led to less invasive techniques and minimizing the extent of surgery in many cases. Other recent cancer advances include improvements in prevention, biomarkerdriven treatment, and therapy combinations that suggest survival can be extended without increasing side effects.

In my own practice, I witness firsthand the incredible strides being made as a result

that collaboration is the key to advancing therapies and improving the lives of our patients. We often talk about dividing and conquering; I think the oncology world is a place where we must unite and conquer to accelerate progress for all patients.

Our partnerships will be crucial to success in better outcomes and opportunities for people with cancer.

Cancer is complex, and finding cures for its many forms is not easy or quick. But as the more than 15 million survivors can attest, and as recent progress shows, together we have many reasons to be optimistic about the future. n

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Everyday Amazing

BREAKTHROUGH CANCER RESEARCH

UNSURPASSED CANCER CARE YOU AND YOUR FAMILY SHOULD EXPECT NO LESS

MASS GENERAL CANCER CENTER massgeneral.org/cancer/progress

With a Focus on Survivors, This Cancer Foundation Thinks Beyond the Cure

Developments in Cancer Care Give Reasons for Optimism

A star-powered fund has awarded $5.4 million in research grants to help people not just survive but thrive after cancer.

As a cancer survivor, “Good Morning America” co-anchor Robin Roberts is in good company: an estimated 17 million cancer survivors are living in the United States today. Yet five years after her breast cancer diagnosis, Roberts learned she had myelodysplastic syndrome, a rare blood cancer. Doctors told her it was likely a long-term side effect of the chemotherapy that had saved her from breast cancer.

Motivated to act Roberts partnered with the V Foundation for Cancer Research to create the Robin Roberts Thrivership Fund, which supports research aimed at improving the outlook for cancer survivors.

“Cancer survivorship is finally coming to the forefront. While cancer prevention and treatment are critical, helping survivors thrive is equally important,” Roberts said at the fund’s launch event in 2017. Just over two years in, the fund has awarded $5.4 million to date in support of nine promising research projects.

Researchers are using this funding to pursue two main avenues. The first is to develop new or improved therapies with fewer side effects. A second avenue, called personalized medicine, focuses on giving doctors tools to identify which therapies are most likely to work for each patient’s specific cancer, thus minimizing their exposure to unnecessary treatments and side effects.

Staying vigilant As the research moves forward, there is one thing all cancer survivors can do to stay on top of their health: visit a doctor regularly. Keeping up with regular checkups is vital to catching any issues early on. And that can make all the difference between surviving — and thriving. n Anne Frances Johnson, Freelance Writer, The V Foundation for Cancer Research 4 • FUTUREOFPERSONALHEALTH.COM

Breakthroughs in cancer research, screening, prevention, and treatment will be life-saving for patients in the years to come.

Cancer care is changing rapidly, and the pace of change is accelerating. In 2019, major advances in precision medicine, gene-based therapy, immunotherapy, and many other areas brought new hope to countless patients. City of Hope clinicians and researchers are brimming with optimism as 2020 begins and have a number of predictions for imminent breakthroughs in understanding, detecting, and treating cancer.

Liquid biopsies “Liquid” biopsies can detect tumor DNA in the blood, identifying early progression or resistant disease faster than other methods. This is likely to be increasingly used in the United States for measuring residual disease and recurrence.

“Our crystal ball is very clearly showing an increased trend for patients to be monitored with liquid biopsies,” said Stephen Gruber, M.D., Ph.D., M.P.H., director of City of Hope’s Center for Precision Medicine.

“A simple blood test can now detect disease recurrence up to one year before it can be detected by imaging or other routine tumor mark-

ers,” added City of Hope colorectal cancer specialist Marwan G. Fakih, M.D.

dicted “an off-the-shelf CAR T-cell will show promise in early studies” in 2020.

Theranostics Researchers predict greater utilization of image-guided management in diseases using theranostics — a combination of “therapeutics” and “diagnostics” — to diagnose and treat cancer at the same time. One example is using a radioactive agent in the imaging process to “light up” cancer cells, then immediately deploying a second agent to attack those cells.

“We will see a further role of image-guided management in diseases including prostate cancer,” predicted City of Hope radiation oncologist Arya Amini, M.D., “where we can utilize imaging to detect microscopic disease that routine scans would not be able to identify.”

Personalized medicine There will be increased focus on personalized treatment plans by analyzing both a tumor’s genetic makeup and each patient’s “germline,” the inherited genetic characteristics that make each individual unique. “This will be a very important step toward driving the use of genomics in oncology to help patients and their families,” predicted City of Hope clinical geneticist Thomas Slavin, M.D., because of all the added data it will provide, especially regarding a person’s risk of developing future tumors.

Immunotherapy In current CAR T therapy, each patient’s own immune cells are reengineered to seek out and attack cancer, a painstakingly slow and expensive process. “Offthe-shelf” CAR T (immunotherapy) treatments can be developed with donor cells, reducing the cost of the procedure and widening its availability. City of Hope gene therapy pioneer John A. Zaia, M.D., the Aaron D. Miller and Edith Miller Chair for Gene Therapy, pre-

Digitization The digitization of electronic medical records, radiology, and pathology allows for application of artificial intelligence in precision medicine. Synthesis of this information will enable early detection and patient-specific treatment optimization.

“Technology is advancing at such a rapid pace,” said City of Hope stomach cancer surgeon Yanghee Woo, M.D. “We pioneer the translating of these tools to ensure the safety, efficacy, and oncologic benefit to our patients.” n Samantha Bonar, Senior Manager of Content, City of Hope MEDIAPLANET

We Need to Talk About Metastatic Breast Cancer Timothy Cook, senior vice president of global oncology at Athenex Oncology, a U.S.-based global biopharmaceutical company, talks about the driving force behind Athenex Oncology.

As you prepare for launch, tell us about a person you met who has inspired you to push forward.

Claire. I’ll never forget her zest for life. Claire was a valued member of the Athenex team, a soccer mom, and an advocate for everyone facing metastatic breast cancer (MBC). We sadly lost Claire earlier this year, but her spirited personality lives on in all of us.

What values do you live by at Athenex Oncology?

We recognize the entire person receiving treatment and the impact on their life. We are working with advocacy groups to better support underserved populations of people facing MBC. Many companies say they’re patient-centric, but it’s truly at the heart of everything we do.

Name something that has surprised you about MBC. Everyone knows about breast cancer thanks to the pink movement, but there is a huge gap in knowledge about MBC specifically. Even the way cases are reported does not break down MBC as a separate disease. People like Claire prove that a 25 percent five-year survival rate is simply not good enough. n This piece has been paid for by Athenex Oncology 6 • FUTUREOFPERSONALHEALTH.COM

Communication Is Key to Caring for Metastatic Breast Cancer This year, approximately 40,000 Americans will die from metastatic breast cancer, and it is estimated that over 160,000 people are currently living with this diagnosis.

Metastatic breast cancer is another term for stage IV breast cancer, which means the cancer has spread from the breast to other areas of the body.

An overlooked concern While the United States has established excellent prevention and screening programs for breast cancer patients across the country, metastatic breast cancer is not addressed by many of these programs. About 5-8 percent of patients will have

metastatic disease at initial diagnosis, while another 20 percent of patients treated for early stage breast cancer will ultimately develop stage IV breast cancer despite appropriate treatment. These patients are often underserved and stigmatized for their diagnosis.

Support and communication For metastatic breast cancer patients, receiving clear communication from their cancer care team is critical to their care and the decisions they make for treatment. These decisions can impact the quality of their life. Patients must be empowered to make decisions with their care team that reflect their goals, such as returning to work,

spending more quality time with family, and minimizing side effects.

Metastatic breast cancer patients are unique. Kelli M. Davis, a patient and advocate with Metavivor and METUP.org, shares that “my care team creates a dynamic, multi-disciplinary approach focused on my unique mutational base. My medical oncologist is leading research that is our best chance to living longer and better with metastatic breast cancer.

Thanks to engaging oncologists like mine, we not only have a seat in the conversation, we are actively setting our own table.” n Jennie R. Crews, M.D., MMM, FACP, Medical Director, Seattle Cancer Care Alliance Network MEDIAPLANET

Empowered to be bold.

Tell cancer we’re coming for it.

We’re driving a new era of bold thinking in oncology by pioneering improved treatment options that transform lives one patient at a time…until cancer is no more.

Stay up to date on the latest technology in metastatic breast cancer treatment and beyond at AthenexOncology.com/USAToday

AthenexOncology.com/USAToday ©2020 Athenex. APD-0226-01-01/20

Follow us @AthenexOncology

St. Luke’s Is Moving the Needle on Early Detection Early screening for colorectal cancer is instrumental as a preventative measure for saving lives.

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h at do Melania Trump, Matt Damon, and Naomi Campbell all have in common? They turn 50 this year, and just like millions of other individuals around the world, they will be due for their first screening colonoscopy.

One in 23 people will develop colon or rectal cancer in their lifetime, making it the fourth most prevalent cancer type after lung, breast, and prostate. When detected early, colorectal cancer is treatable in about 90 percent of cases. The key is screening compliance.

Fighting colorectal cancer St. Luke’s University Health Network is taking on the colorectal cancer challenge by prioritizing

colon cancer screening across its large network of 11 hospitals and more than 300 outpatient sites throughout Pennsylvania and New Jersey.

“It’s a team approach,” states Nicholas Taylor, M.D., chairman of oncology for St. Luke’s Cancer Center. “Our oncology team, our gastroenterology team, and our primary care providers are working together to really hammer home the importance of preventive screening.”

Screening options Patients over 50 who are seen at St. Luke’s are evaluated for one of three screening tools: colonoscopy, fecal immunochemical test (FIT), or Cologuard®. If they meet the criteria, they are connected with the appro-

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priate information and instructions to schedule a test.

“We really want to be able to move the needle on this particular initiative,” states Dr. Taylor.

“We know that it can potentially save lives.”

A quality study, conducted by a group of St. Luke’s medical students and residents, showed an ability to positively impact the colorectal screening rate in a clinic population through education and access. St. Luke’s medical students and residents were able to double the number of screenings in some locations, going from 22 percent screening rate to 53 percent compliance.

Patient-focused According to Dr. Taylor, this type of initiative and research-focused work is

at the heart of St. Luke’s mission, which always puts the patient first.

Ellen Chwastyk, a stage III colon cancer survivor, is grateful for the patient-centered care she received at St. Luke’s. A busy mom, g rand moth er, and title agency employee, Chwastyk put off her colonoscopy until she experienced unexpected bleeding at age 59. By then, two tumors were discovered, and she needed a variety of treatments including chemo, radiation, and surgery.

Today, Chwastyk is getting ready to celebrate her fourth year of being cancer-free and credits her quality of life to her doctors at St. Luke’s as well as diligent follow-up.

She is a fierce advocate for screening and organizes

her company’s “Wear Blue” day each March to promote awareness.

“Don’t be too busy to take care of yourself,” Chwastyk cautions.

“Going undiagnosed and having a later stage cancer is far worse than going through one day of prep for the colonoscopy. Get screened; it could save your life.”

Grow Your Physician Career!

Consistently ranked as a Top 100 Hospital

by Watson Health, St. Luke’s is currently seeking a Chief of Medical Oncology & Hematology to join its team. n This piece has been paid for by St. Luke’s University Health Network.

Kate Raymond, Director of Marketing and Public Relations, St. Luke’s University Health Network MEDIAPLANET

HEALING BEGINS HERE.

Our patients ARE family.

– Nicholas Taylor, MD, Chairman of Oncology

Cancer is a journey. And our team of experts is by your side every step of the way.

Because, as Dr. Taylor, puts it: “Our sole focus is on always doing what is right for each patient. We don’t let anything get in the way of that. We don’t just treat patients like family – they are family. They touch my life as much as I hope I touch theirs.”

Learn more about St. Luke’s Cancer Center at sluhn.org/cancer.

JOIN OUR TEAM! Chief of Medical Oncology Opening Call 610-509-7041

Pooling Pancreatic Cancer Resources for Better Outcomes PHOTO: © THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

And the thought behind this was a very simple phrase: the power of five.’”

To make faster progress against the disease, five comprehensive cancer centers in the University of California system are working together.

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hen her oncologist found a “questionable spot,” Lorene Freuer had already survived cancer once — just six months before. “The biopsy came back positive for pancreatic cancer,” she recalls. “Once again, I was devastated and even more frightened.”

Fear is a sensible response to pancreatic cancer. While it’s relatively rare (it accounts for just 3 percent of all cancer diagnoses), it’s extremely lethal, leading to 7 percent of all cancer deaths in this country. Luckily for Freuer, she was referred to Dr. Richard Bold, physician-in-chief at the UC Davis Comprehensive Cancer Center.

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“The oncologist who treated her knew that her care was going to be best delivered at UC Davis because of our high volume status,” Dr. Bold says. “She is doing wonderfully well; her cancer was removed completely. I’d say right now things look good.”

The power of five Because pancreatic cancer is so rare, most oncologists lack expertise in treating it. “The oncologist may be treating lung cancer, prostate cancer, pancreatic cancer, colon cancer, and breast cancer,” notes Dr. Bold.

“It is so hard to be an expert in 10 different cancers.”

But California has some unique advantages in this fight. Of just

71 comprehensive cancer centers designated by the National Cancer Institute (NCI) in the United States, California has five — and these see more pancreatic patients than most facilities. In 2017, for example, they treated about 14 percent of all pancreatic cancer patients in the state.

The potential in combining these resources became clear.

“About two years ago, the office of the president of the University of California looked around and said, you know, we have significant strengths in each of the cancer centers, for research, clinical care, outreach, education, and prevention,” Dr. Bold recalls. “So they created the University of California Cancer Consortium.

The consortium The five cancer centers began meeting to discuss how they could share resources. Because the centers see such a high volume of pancreatic cancers, it made sense for one of its first formal groups to focus on it.

“We began sharing genetic and genomic information,” Dr. Bold says. “About 20 percent of pancreatic cancer has an underlying genetic event. Most of the studies to date have not taken a deeper dive into the ethnic, socioeconomic, and genetic differences involved in pancreatic cancer. But California is an extremely diverse state, so California can do that, allowing us to expand on the database and begin to answer questions.”

Another arena where the consortium is having an impact is clinical trials. Typically, pancreatic cancer is a challenging disease to conduct trials on because of its rarity. But the volume of patients in California, enhanced by the partnership between the cancer centers, changed the metrics.

Better treatment Ultimately, the combined resources of the University of California Cancer Consortium will benefit those who need help most: the patients.

“Outcomes are better from the surgical standpoint, and probably the medical and radiation standpoint, when those doctors are treating patients with rare diseases frequently,” notes Dr. Bold.

For her part, Freuer agrees. “I am profoundly happy with the results of my surgery,” Freuer says. “Dr. Bold gave me my life back!” n Jeff Somers MEDIAPLANET

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Julie Sutcliffe, Ph.D. Professor, Internal Medicine and Biomedical Engineering

For more information visit

cancer.ucdavis.edu

Fran Drescher Fights Cancer With Humor When Fran Drescher was diagnosed with uterine cancer, it took two years to get a proper diagnosis. “I was technically too young and too thin to get uterine cancer,” Drescher said.

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If she knew then what she knows now, she would have insisted on an endometrial biopsy to rule out uterine cancer. “Turns out it’s a two-minute, in-office test,” she said. “It should have been done.”

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Early detection Since her diagnosis, Drescher, the star of the upcoming NBC series “Indebted,” wrote the New York Times bestseller “Cancer Schmancer” and began a nonprofit of the same name.

“I started the Cancer Schmancer movement to empower people to transform from patients into medical consumers, to recognize the early warning whispers of the cancers that may affect them, and to know the tests that are available, because all too often they’re not even on the menu at the doctor’s office.”

When Drescher began her organization, she was focused primarily on early detection. “When I went on my book tour, I realized that what had happened to me had happened to many people by means of mistreatment and misdiagnosis,” she said. “Early detection became the cornerstone because that was something that needed to change — for

patients to be diagnosed in stage one when it’s most curable.”

Preventing cancer As the movement grew, its aims began to expand, encompassing research and lobbying for the prevention of cancers. “I began to learn a lot more, and I realized that 95 percent of all disease is environmentally stimulated,” she said.

Cancer Schmancer now runs a program called Detox Your Home, which encourages people to host parties and get rid of toxic cleaning products and processed foods.

“Let’s not get cancer in the first place, how’s that for an idea,” Drescher said.

Family matters Going through a cancer diagnosis can be a difficult experience, not only for the patient, but also for their family and friends. “Family is very important,” Drescher said.

“Never go to the doctor by yourself. Have somebody there with a pen and a pad, and before you go into the doctor, think of a lot of questions. Write the questions down and then have the person in the examining room with you, talking to the doctor, writing down everything.” This is one of Drescher’s main messages — to encourage people to be more proactive when it comes to dealing with health professionals.

Given her success as a comedian, Drescher understands the importance of seeing the positive side during times of stress and grief.

“One of the most important things is that it’s a slice of the pie, it’s not the whole pie,” she said. “When you’re in the depths of despair, it’s hard to see the tiny miracles that are all around you. It’s hard to believe — though this is the absolute truth — that side-by-side with grief lies joy.” n Ross Elliott

Football Coach Mark Nofri Encourages Men to Screen for Cancer Early Mark Nofri, head coach for the Sacred Heart University football team, was diagnosed with colon cancer in 2015.

Now he encourages other men to test early.

Mark Nofri was beginning his fourth season as head coach for the Sacred Heart University football team when he received life-changing news. “I was diagnosed with stage 3 colon cancer on March 20, 2015,” he said. “That kind of came out of the blue.”

Immediate intervention Nofri began consulting with Dr. Jill Lacy and surgeon Dr. Walter Longo at Yale New Haven Hospital. “When I had met with Dr. Longo, he said that there was only one way that he knew how to treat this, and that was aggressively,” Nofri said.

“Within seven days, I was on the table. They took out 33 lymph nodes and found three more infected as well, so we decided that we needed to do chemotherapy treatment every Monday for seven months, 12 total treatments going every other week.”

Focus on the goal The regular chemotherapy treatments were the hardest times Nofri had ever experienced. “I’ve never experienced anything in my entire life that was so hard,” he said. To get through the painful chemotherapy, Nofri had to keep the end goal in sight.

“What you are doing is putting poison in your body,” he said. “You’re trying to kill something in your body and bloodstream.

Your body is fighting it off and it doesn’t have a good reaction, and it knocks you down. But when you fight through it and find out you’re cancer-free and finish treatment, you feel like you got a new lease on life.”

The right support Having the support of his football team as well as his family helped Nofri get through the worst of it.

“One of the only things that got me through was that I continued to coach and be around my players,” he said.

It helped to be “hearing their support and watching me go through it and encouraging me to work through it to get through the treatment.”

PHOTO: SCOTT MCLAUGHLIN

Screening Earlier for Cancer Can Help Save Lives

Supporting other patients Having successfully beaten his cancer, Nofri shares his story openly, hoping to encourage other men who have similar experiences to do the same. “When I hear someone else has colon cancer, I’m very open to talking to them, sharing stories, and giving them support.”

Nofri also hopes to encourage men to get tested early. “If I can have two or three people get a colonoscopy by sharing my story, I would have done some good,” he said. “I’m a big proponent of making people understand that no one should be waiting until 40 or 50, but rather 30 years old, every three to five years.

The procedure’s not great, but it keeps you from going through the surgery and keeps you from chemo. No one wants to do that and fight off that cancer.”

For men going through cancer treatment, Nofri offered this advice: “Lean on friends and family, don’t be afraid to ask for help, and let people help you through the process. Don’t feel sorry for yourself. Go be active; go fight!” n Ross Elliott

Colorectal cancer is often thought of as an “old person’s disease.” But increasingly, that’s not the case. Think you’re too young for this disease? You’re not.

The national colorectal cancer rate is dropping in part because more people are getting screened. But for adults under 50, rates are increasing. If the trend continues, MD Anderson Cancer Center researchers estimate that by 2030, rates of colon cancer will increase by 90 percent and rectal cancer will increase by 124 percent among adults ages 20-34.

Earlier screening In 2018, the American Cancer Society lowered the recommended age to begin screening from 50 to 45. The Prevent Cancer Foundation® supports that recommendation and is working to improve awareness of the issue and encourage action.

Creative messaging that appeals to a younger audience is critical to raising awareness and inspiring action. The Foundation launched a public awareness campaign in 2019 called “Too Young for This Sh*t” that uses cheeky graphics to educate adults under 50 about the disease.

New screening technology The good news is that improvements in screening are driving hope in colorectal cancer. The colonoscopy has been the gold standard for decades. Now, at-home stool tests are about as effective as colonoscopies at reducing mortality if done as recommended (every one to three years depending on the test, with a colonoscopy recommended every 10 years), and if abnormal results are followed up with a colonoscopy.

Research shows people are more likely to get screened for colorectal cancer when offered a variety of options for screening.

As doctors and researchers work to further advance cancer screening, early detection can become a reality for more people. n Carolyn R. Aldigé, Founder and CEO; Cassie Smith, Senior Manager, Congressional Families Cancer Prevention Program, Prevent Cancer Foundation® MEDIAPLANET • 13

Mohs Surgery: The Gold Standard in Skin Cancer Treatment

There are more skin cancers diagnosed each year in the United States than all other cancers combined. The gold standard skin cancer treatment to achieve the highest cure rate is Mohs micrographic surgery.

Mohs surgery was named in honor of Dr. Frederic Mohs, who developed the basic technique over 50 years ago. Since Dr. Mohs first described the surgical procedure, many technical improvements and refinements have

contributed to making it a safe and highly effective means of treating skin cancers including basal cell cancers, squamous cell cancers, and melanoma.

Mohs surgery technique The main difference between Mohs surgery and other methods of removing skin cancers is meticulous microscopic control, where the surgeon also functions as the pathologist reading the slides.

As the skin cancer is

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surgically removed, it is mapped by the Mohs surgeon so its exact location can be pinpointed. Every layer of tissue removed is inspected under the microscope for evidence of cancer cells at both the peripheral and deep margins.

If any skin cancer cells are seen, the Mohs surgeon continues to remove and examine sequential tissue layers. The Mohs surgeon is able to locate the cancer cells based on this meticulous mapping technique. When no fur-

ther skin cancer cells are identified, the Mohs surgeon can be confident that the entire base and sides are tumor free.

Healthy skin In addition to ensuring total removal of the cancer cells, this technique also preserves as much normal, healthy skin as possible. Mohs surgery is indicated for skin cancers that are located in highrisk areas such as the head and neck; skin cancers that are large, aggressive, and difficult to treat

with other therapies; or recurrent cancers.

Mohs micrographic surgery is performed in an outpatient setting under local anesthesia and is very safe and very well-tolerated. Since tissue is only removed until the cancer is no longer present, the Mohs surgery minimizes the size of the surgical wound and should reduce the size and appearance of the final surgical scar. n Marc D. Brown, M.D., President, American Society for Dermatologic Surgery MEDIAPLANET

When treating locally advanced basal cell carcinoma (laBCC)

COULD MEAN THE WORLD TO YOUR PATIENTS ODOMZO® (sonidegib) is the only hedgehog pathway inhibitor proven to provide a median duration of response of more than 2 years

INDICATION ODOMZO (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.

IMPORTANT SAFETY INFORMATION WARNING: EMBRYO-FETAL TOXICITY • ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ODOMZO is embryotoxic, fetotoxic, and teratogenic in animals • Verify the pregnancy status of females of reproductive potential prior to initiating therapy. Advise females of reproductive potential to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dose • Advise males of the potential risk of exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with ODOMZO and for at least 8 months after the last dose

Please see additional Important Safety Information on the following pages, and accompanying Brief Summary of Prescribing Information including Boxed WARNING.

The only hedgehog pathway inhibitor proven to provide more than 2 years of tumor response in laBCC1,2 ODOMZO (sonidegib) delivers effective and durable results

56%

2

>

Objective Response Rate (n=37/66; 95% CI: 43-68)

YEAR median Duration of Response (95% CI: 10.1, NR)

0

6 mos.

1 year

18 mos.

26.1

months

2 years

30 mos.

Objective response rate (ORR): ORR=Complete Response (CR of 5%, n=3) + Partial Response (PR of 52%, n=34).

PR is defined as ≥50% decrease in the sum of the product of perpendicular diameters (SPD) of the lesions by photo assessment and 30% decrease in the sum of diameters of lesions per MRI. Duration of Treatment (DoT): Patients were treated with ODOMZO for a median duration of 11 months (range 1.3 to 33.5 months).1 Duration of Response (DoR): At the 30-month data analysis, the median DoR was 26.1 months.1

The BOLT* trial design1-3 A multicenter (58 centers, 12 countries), randomized, double-blind, phase II study evaluating the once-daily dose of ODOMZO in 194 patients with laBCC. Patients were randomized 1:2 to receive the 200 mg (n=66) or 800 mg (n=128) dose. The primary end point of ORR, defined as CR + PR, was assessed by blinded independent central review. Response was based on the mRECIST† criteria (composite of MRI assessments of target lesions, digital clinical photography, and histopathology assessments via punch biopsies). There was no evidence of better ORR among the 128 patients with laBCC receiving ODOMZO 800 mg daily. The 200 mg dose was selected for use based on benefit-risk profile. *BOLT=Basal cell carcinoma Outcomes with LDE225 Treatment. LDE225 was the investigative term for sonidegib.2 †mRECIST=modified Response Evaluation Criteria In Solid Tumors.1 CI=confidence interval; laBCC=locally advanced basal cell carcinoma; MRI=magnetic resonance imaging; NR=not reached.

IMPORTANT SAFETY INFORMATION (continued) Embryo-fetal Toxicity: ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. Females of Reproductive Potential: Verify pregnancy status prior to initiating ODOMZO. Advise females to use effective contraception and not to breastfeed, due to the potential for serious adverse reactions in breastfed infants, during treatment and for at least 20 months after the last dose. Report pregnancies to Sun Pharmaceutical Industries, Inc. at 1-800-406-7984.

Males: Advise males to use condoms, even after a vasectomy, and to not donate semen during treatment and for at least 8 months after the last dose to avoid potential drug exposure in pregnant females or females of reproductive potential.

Blood Donation: Advise patients not to donate blood or blood products while taking ODOMZO, and for at least 20 months after the last dose because their blood or blood products might be given to a female of reproductive potential.

ODOMZO demonstrated clinically meaningful responses even in patients with aggressive histology1

> At baseline—Dorothy starts ODOMZO 200 mg to treat lesions on her forehead and face.4

At 13 months—Dorothy achieved partial tumor response with ODOMZO.4

Large tumor diameter: Large diameter as measured by visual exam or MRI5 Dorothy is a 57-year-old Caucasian female with large laBCC with sclerosing (morpheaform) histology on her forehead. She was first diagnosed with BCC in January 1992. In January 2004, the BCC recurred. Dorothy experienced these treatmentrelated adverse reactions: muscle spasms, alopecia, elevated CK levels, dysgeusia, nausea, and lipase elevation.4 This case study details an individual patient treated with ODOMZO. It is not intended to convey medical advice.

Individual results may vary.

Patient name has been changed to protect privacy.

Greater than 90% of the most common ARs were Grade 1 and Grade 21 ODOMZO was temporarily interrupted in 20% of patients and permanently discontinued in 34% of patients due to adverse reactions1 Adverse reactions reported in at least 2 patients that led to discontinuation of the drug were: muscle spasms and dysgeusia (each 5%); asthenia, increased lipase, and nausea (each 4%); fatigue, decreased appetite, alopecia, and decreased weight (each 3%). Serious adverse reactions occurred in 18% of patients1 ODOMZO showed no new safety concerns at the 30-month analysis2 BCC=basal cell carcinoma; CK=creatine kinase.

IMPORTANT SAFETY INFORMATION (continued) Musculoskeletal Adverse Reactions: Musculoskeletal adverse reactions, which may be accompanied by serum creatine kinase (CK) elevations, occur with ODOMZO and other drugs which inhibit the hedgehog (Hh) pathway. Obtain serum CK and creatinine levels prior to initiating therapy, periodically during treatment, and as clinically indicated. Temporary dose interruption or discontinuation of ODOMZO may be required based on the severity of musculoskeletal adverse reactions.

Premature Fusion of the Epiphyses: ODOMZO is not indicated for use in pediatric patients.

Premature fusion of the epiphyses has been reported in pediatric patients exposed to ODOMZO and other Hh pathway inhibitors. In some cases, fusion progressed after discontinuation.

Please see additional Important Safety information throughout, and accompanying Brief Summary, including Boxed WARNING.