FINDING CANCERIs Easy Detection A Reality?

Moderator: Elaine Schattner, MD, MA, Physician & Patient Advocate, New York, NY

Kevin ConroyChairman & CEO Exact SciencesMadison, WI

Sam Hanash, MD, PhDProfessor of Cancer Prevention and Molecular Pathology The University of Texas MD Anderson Cancer Center Houston, TX

Luke TimmermanBiotech JournalistFounder and Editor, Timmerman ReportSeattle, WA

Session Plan:Up For Debate: Why Screen For Cancer?

1. Debate? Pros & Cons of Early Detection A Bit of History, Stats & Facts

2. Liquid Biopsy: ctDNA, CTCs…Grail? Cancer Detection vs. Monitoring Q & A

3. Cologuard for Colon and Rectal Cancer Screening Q & A4. What Limits Adoption of Novel Detection Methods? Science #Education…#Regulation…#Costs… Is DTC marketing appropriate? Q & A

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Early Cancer Detection: Pros & ConsPoint: If screening is accurate, it could result in less treatment and better outcomes.Save Lives, Extend LivesMinimize Treatment less toxic drugs, smaller surgery Cure? Lower costs of care?

Counterpoint: Screening can lead to false alarms, evaluation and treatment of people who have slow-growing, “benign” tumors. Overtreatment surgery, medication, radiation toxicity, even death needless worry & griefCosts without reason

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Cervical Cancer: A Detection Success Story

high-grade cervical cell dysplasia

History: Before 1960, cervical cancer was a common cause of illness and mortality in U.S. women. Now: In years since screening with Pap smears began, cervical cancer is infrequent; deaths are rare.

(The Milbank Quarterly, Vol. 90, 2012)

Future: Can we prevent cervical cancer by immunizing against HPV?.

(Dr. E. Uthman, Wikimedia)

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Cancer Care is Expensive

Mariotto et al. NCI 2011;103(2): 117–28.#cancertech 5

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Cancer Is a Leading Cause of Death Worldwide

Annual toll:US: 1.7 M cases, 595,690 deaths Global: 14 M cases, 8 M deathsToll expected to surpass 20M in 2020

Many cancer are stage III or IV at diagnosis.Within the U.S. and globally, this varies – and is changing.

New Tech!

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Cell-free DNA (cf-DNA)Circulating tumor DNA (ctDNA)Circulating tumor cells (CTCs)ExosomesMicro-RNA Other

What is a Liquid Biopsy?

A CTC lights up the androgen receptor in a metastatic prostate cancer cell (image from Epic Sciences, San Diego)

DNA sequence from a normal and tumour cell (Wellcome Trust image)

Blood is chock-full of stuff

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Is Screening Blood for Cancer Feasible, or Wise?

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Fishing Expedition?

Deadliest Catch, (Discovery image)

Q & A

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Liquid Biopsies: For Detection or Cancer Monitoring?

Breaking Bad, early episode (AMC)Around the time of Walter White’s lung cancer diagnosis:Might Walter have benefited from early detection?

Breaking Bad, Season 5 (AMC)Late in Walter White’s journey:Might he have benefited from monitoring during treatment?#cancertech 11

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134,490new diagnoses

Esophageal

Prostate Pancreas Breast Colorectal Lung

15,690

26,120

41,780 40,89049,190

158,080

Annual cancer deaths

$20 billion

projected annual treatment costs in

2020

Colon Cancer: America’s Second Deadliest

Sources: CDC, MMWR 2013; ACS Cancer Stats & Figures (2016)

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Poop and Looking Inside: Ways to Check for Signs of Colon and Rectal Cancer

NCI image (Terese Winslow, illustrator)Colon cancer screening (image: U.S. government, Navy)#cancertech 14

How Does Cologuard Compare with FOBTand Other Colorectal Cancer Screening Methods?

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Early Colorectal Cancer Detection is CriticalAnd Underused:

9 out of 10survive 5 years

Diagnosed in Stages I or II

Diagnosed in Stage IV

1 out of 10survive 5 years

60% of patients diagnosed stages III-IV

Stagnant screening rates:

(Inadomi JM, et al. Adherence to Colorectal Cancer Screening, a Randomized Clinical Trial of Competing Strategies. Arch Intern Med. 2012;172(7):575-582).

2005 2008 2010 2013 2018 2020

50% 52%59% 58%

(only 38% for colonoscopy)*

80% 80%

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How Does Cologuard Work?

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Stool DNA test: looks for hidden blood and 11 biomarkers (10 DNA & 1 protein)

Completed at home, returned via UPS, no medication, no prep, no sedation

FDA-approved & covered by Medicare

Included in American Cancer Society guidelines & U.S. Preventive Services Task Force draft guidelines

Cologuard vs. other non-invasive options:

What’s the Experience with Cologuard?

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71%Patient

compliance*

88%Patients

rated experience positive

42%Patients

never screened

before*Patient compliance rate: number of valid test results reported divided by the number of collection kits shipped to patients 60 or more days prior to December 31, 2015 – information from Exact Sciences, for ages 50 -74

Source: Colorectal Cancer Screening with Multi-target stool DNA-based Testing Previous Screening History of the Initial Patient Cohort, poster presented at American College of Gastroenterology's Annual Scientific Meeting (ACG 2015), Oct. 16-21, 2015 Q & A

What Limits Use of New Cancer Screening Tools?

Role of Education: Need for better education of doctors in modern science including genetics

- How do practicing physicians learn about new tech?

- Greater education of the public, in science?

Screening Guidelines:Costs & Iffy Insurance Coverage:Regulatory Issues:

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Finding Cancer in Other Body Fluids?

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Is Advertising OK?

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Q & A

What’s the Future of Early Cancer Detection?

Q & A, General Discussion

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Thank you!

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Kevin Conroy@ExactSciences

Sam Hanash@MDAndersonNews

Luke Timmerman@ldtimmerman

Elaine Schattner@ESchattner