precision medicine in oncology
TRANSCRIPT
Diagnostics and treatment pathways for cancer patients
November 29, 2016
Precision medicine in oncology
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Panelists
Dr. Paul Wheatley-PriceMedical Oncologist, Ottawa HospitalPresident, Lung Cancer Canada
Dr. Diana IonescuOncological Pathologist, British Columbia Cancer AgencyDepartment of Pathology
Rachael ManionSenior Associate, 3Sixty Public Affairs
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Pathologic examination has been the gold standard
for diagnosis of cancer for over a century
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• Testing tumors to identify the best treatment for the right patient at the right time
• Biomarker testing
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Biomarkers
• A characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention (National Institute of Health definition).
• Biomarkers can be used:– To understand the pathobiology of the disease– For diagnosis– For disease monitoring– As a specific target for drugs
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Biomarkers being used across diseases – but most frequent application in cancer
http://chartpack.phrma.org/personal-medicines-in-development-chartpack/a-new-treatment-paradigm/personalized-medicines-are-benefitting-patients-across-many-different-diseases
*FDA approvals with biomarker information in the approved labelingSource: U.S. FDA, “Paving the Way for Personalized Medicine,” Oct 2013
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How Can Biomarker Testing Optimize Patient Care in Oncology?
• Correct Diagnosis
• Correct Treatment
• Correct Drug Dose
Biomarker testing identify subgroups of patients for whom select drugs are most effective and safe
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ScienceEconomic reality
Clinical biomarker testing in Canada
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BIOMARKER TESTING IN ONCOLOGY
Similarities to current standard approaches
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An Analogy:Bacteria testing determines the right antibiotic• Personalized care is not new to medicine:
– Laboratory testing to assess the sensitivity of infectious agents to various antibiotics is an established cornerstone in determining therapy
– This well established approach ultimately:• Improves patient outcomes• Avoids side effects or inappropriate treatment• Shortens hospital stays• Minimizes unnecessary physician visits
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Testing for Appropriate Antibiotic Therapy
Long term outcomes:• Testing process helps to limit antibiotic resistance• Avoid health care complications (including death)• Prevent unnecessary expenses
• This entire chain of medical events is most efficiently and effectively directed by relatively inexpensive but highly reliable and specialized tests that are implemented in a timely fashion
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Best Use of Health Resources
• As with antibiotics, a relatively inexpensive laboratory test can determine the best use of health care resources
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Cancer Molecular Testing: A revolution started with targeted therapy
• Similarly, the greater our understanding of the molecular diversity of cancers, the greater our awareness of their unique sensitivity and resistance to specific drugs
• The role of oncologic pathology is increasingly important with the introduction of precedented new standards for companion diagnostic tests to identify patients who will best benefit from a given targeted anticancer drug*
*Butts et al. Curr Oncol. Oct 2013; 20(5): e475–e483*Ellis et al. Journal of Thoracic Oncology • Volume 6, Number 8, August 2011*CAP IASLC AMP Molecular Testing Guideline in Lung Cancer. J Thorac Oncol April 2013
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As Sir William Osler noted more than a century ago…
"As is your Pathology, so is your Medicine"
Diana N. Ionescu, MD, FRCP(C), FCAPSenior Consultant Pathologist, BC Cancer Agency Clinical Professor, University of British ColumbiaEmail: [email protected]
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Photos: http://www.leicabiosystems.com
Biomarkers are helping personalize cancer care…
Different People’s Tumours Have Different Biomarkers
Biomarkers commonly found innon-small cell lung cancer
ALK EGFRKRAS PD-L1
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Biomarkers being used across diseases – but most frequent application in cancer
http://chartpack.phrma.org/personal-medicines-in-development-chartpack/a-new-treatment-paradigm/personalized-medicines-are-benefitting-patients-across-many-different-diseases
*FDA approvals with biomarker information in the approved labelingSource: U.S. FDA, “Paving the Way for Personalized Medicine,” Oct 2013
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The pre-biomarker eraToxicitiesUncertain benefitLimited to fitter patients
Disease controlImproved cancer symptoms
Response Stable Progression
Traditional chemotherapy
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Multiple subtypes of lung cancer identifiable
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EGFR inhibitor or chemotherapy?
Han et al. NEJ002. NEJM 2010 (362): 2380-88
Clinical impact of treatment• Commenced gefitinib 250mg od Jan 2012• Grade 1 rash and diarrhea• Vision improved within a few weeks
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Dec 2011 March 2012
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Osimertinib – for emerging T790M resistance mutation
Janne et al. NEJM 2015; 372(18): 1689-1699
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Meaningful benefits
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In Canada, biomarker tests follow a varied and complex path to health system adoption and patient access
Regulatory Authorization
Health Technology Assessment
Funding Decisions
Health System
Adoption / Patient Access
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2016 State of PlayPatients with advanced NSCLC and good PS
Wildtype NSCLC
Platinum doublet CT
Pemetrexed or Docetaxel
Erlotinib
ALK positive
Crizotinib
EGFR positive
Gefitinib / Erlotinib Afatinib
3rd gen TKI 2nd gen ALK
ROS1 positive
Nivolumab
Maintenance pemetrexed
Crizotinib
Line
1st
Maint
2nd
3rd
PDL1: Pembrolizumab
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Funding for different technologies
Hospitals Drugs Healthcare providers Laboratory
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New assessment process for both drugs and companion tests
CADTH: CDR Update – Issue 120, CADTH’s Proposed Process for the Assessment of Companion Diagnostics
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Biomarker testing priorities• National precision medicine strategy • Molecular oncology strategies
– SK: 2015-2020 Strategic Plan• Develop molecular oncology strategy
– MB: • Manitoba Cancer Plan 2016-2021 (April 1, 2016)
– Increase access to genetic testing to support personalized treatment• Diagnostic Services Manitoba Strategic Plan 2016-2020: Results that Matter
– Plan, prioritize and implement molecular diagnostic tests in pathology (e.g. EGFR for lung cancer)– Introduce next generation sequencing into the clinical laboratory (for BRCA1/2 and EGFR, etc.)
– ON: Ontario’s Cancer Plan IV, 2015-2019: • Begin implementation of pathology accountability framework: 2019• Develop a personalized cancer care strategy: 2019
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Gaps, challenges and opportunities remain…• No clear, consistent pathway for health system uptake• Rapidly evolving knowledge on the role / place of
biomarkers in treatment guidelines• Knowledge translation to patients• New drugs / diagnostics are perceived as challenges
to budgets / health system sustainability• Lack of evidence development programs and data
collection
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There are many ways patients can engagePatients can ask the right questions:• What biomarker tests are recommended and
why?• How are the tests performed?• How often do I need the tests?• What do the results of the tests mean?• How will the results affect my treatment options?
Patients can engage in the policy discussion:• Getting involved in personalized medicine policy
and advocacy
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Canadian Cancer Survivor Network Contact Info
Canadian Cancer Survivor Network1750 Courtwood Crescent, Suite 210Ottawa, ON K2C 2B5Telephone / Téléphone : 613-898-1871E-mail [email protected] or [email protected] Web site www.survivornet.caBlog: http://jackiemanthornescancerblog.blogspot.com/Twitter: @survivornetcaFacebook: www.facebook.com/CanadianSurvivorNet Pinterest: http://pinterest.com/survivornetwork/