Precision Medicine in Oncology
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Please share this webinar with anyone who may be interested! Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR Cancer care is increasingly tailored to individual patients, who can undergo genetic or biomarker testing soon after diagnosis, to determine which treatments have the best chance of shrinking or eliminating tumours. In this webinar, a pathologist and clinical oncologist discuss: ● how they are using these new tests, ● how they communicate results and treatment options to patients and caregivers, and ● how patients can be better informed on the kinds of tests that are in development or in use across Canada View the video: https://youtu.be/_Wai_uMQKEQ Follow our social media accounts: Twitter - https://twitter.com/survivornetca Facebook - https://www.facebook.com/CanadianSurvivorNet Pinterest - https://www.pinterest.com/survivornetwork YouTube - https://www.youtube.com/user/Survivornetca
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Precision Medicine in Oncology
- 1. Diagnostics and treatment pathways for cancer patients November 29, 2016 Precision medicine in oncology
- 2. Panelists 2 Dr. Paul Wheatley-Price Medical Oncologist, Ottawa Hospital President, Lung Cancer Canada Dr. Diana Ionescu Oncological Pathologist, British Columbia Cancer Agency Department of Pathology Rachael Manion Senior Associate, 3Sixty Public Affairs
- 3. Pathologic examination has been the gold standard for diagnosis of cancer for over a century 3
- 4. 4 • Testing tumors to identify the best treatment for the right patient at the right time • Biomarker testing
- 5. 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 5
- 6. Biomarkers being used across diseases – but most frequent application in cancer 6 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 labeling Source: U.S. FDA, “Paving the Way for Personalized Medicine,” Oct 2013
- 7. 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 7
- 8. ScienceEconomic reality Clinical biomarker testing in Canada 8
- 9. BIOMARKER TESTING IN ONCOLOGY Similarities to current standard approaches 9
- 10. 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 10
- 11. 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 11
- 12. Best Use of Health Resources • As with antibiotics, a relatively inexpensive laboratory test can determine the best use of health care resources 12
- 13. 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* 13 *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
- 14. As Sir William Osler noted more than a century ago… "As is your Pathology, so is your Medicine" 14 Diana N. Ionescu, MD, FRCP(C), FCAP Senior Consultant Pathologist, BC Cancer Agency Clinical Professor, University of British Columbia Email: dionescu@bccancer.bc.ca
- 16. Biomarkers are helping personalize cancer care… Different People’s Tumours Have Different Biomarkers Biomarkers commonly found in non-small cell lung cancer ALK EGFRKRAS PD-L1
- 17. Biomarkers being used across diseases – but most frequent application in cancer 17 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 labeling Source: U.S. FDA, “Paving the Way for Personalized Medicine,” Oct 2013
- 18. The pre-biomarker era 18 Toxicities Uncertain benefit Limited to fitter patients Disease control Improved cancer symptoms Response Stable Progression Traditional chemotherapy
- 19. Multiple subtypes of lung cancer identifiable 19
- 20. 20 EGFR inhibitor or chemotherapy? Han et al. NEJ002. NEJM 2010 (362): 2380-88
- 21. Clinical impact of treatment • Commenced gefitinib 250mg od Jan 2012 • Grade 1 rash and diarrhea • Vision improved within a few weeks 21 Dec 2011 March 2012
- 22. Osimertinib – for emerging T790M resistance mutation 22Janne et al. NEJM 2015; 372(18): 1689-1699
- 24. In Canada, biomarker tests follow a varied and complex path to health system adoption and patient access 24 Regulatory Authorization Health Technology Assessment Funding Decisions Health System Adoption / Patient Access
- 25. 25 2016 State of Play Patients 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
- 26. Funding for different technologies 26 Hospitals Drugs Healthcare providers Laboratory
- 27. New assessment process for both drugs and companion tests 27 CADTH: CDR Update – Issue 120, CADTH’s Proposed Process for the Assessment of Companion Diagnostics
- 28. 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 28
- 29. 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 29
- 30. There are many ways patients can engage Patients 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 30
- 31. 31
- 32. Thank you! William (Bill) Dempster wdempster@3sixtypublicaffairs.com 613.800.8344 (direct) 613.614.0283 (mobile) 32
- 33. Canadian Cancer Survivor Network Contact Info Canadian Cancer Survivor Network 1750 Courtwood Crescent, Suite 210 Ottawa, ON K2C 2B5 Telephone / Téléphone : 613-898-1871 E-mail jmanthorne@survivornet.ca or mforrest@survivornet.ca Web site www.survivornet.ca Blog: http://jackiemanthornescancerblog.blogspot.com/ Twitter: @survivornetca Facebook: www.facebook.com/CanadianSurvivorNet Pinterest: http://pinterest.com/survivornetwork/
Notes de l'éditeur
- An increasing number of treatments are personalized across a variety of therapeutic areas. While the highest number of personalized treatments are developed for oncology, it is also growing for other therapeutic areas such as psychiatry, infectious diseases, cardiology, endocrinology and neurology. With regard to oncology, cancer patients have seen a four-fold increase in their personalized treatment options in 10 years (Sources: IMS Institute for Healthcare Informatics, “Innovation in Cancer Care and Implications for Health Systems: Global Oncology Trend Report,” May 2014 (accessed May 2015); National Cancer Institute, “NCI Dictionary of Cancer Terms” (accessed May 2015)).
- Many biomarkers are being studied in cancer, and what we recognize now is that no two people are exactly the same; no patients’ tumors are exactly the same. Specifically, different people’s tumours can have different biomarkers. For example, biomarkers tests available to lung cancer patients include: KRAS mutation analysis: KRAS is a gene that may cause cancer when it is mutated, or changed. Tumors with a KRAS mutation do not have mutations in EGFR or ALK, and cannot be treated with drugs that target these two abnormal proteins. ALK testing: People with a mutation in the ALK gene may respond to ALK inhibitors, which block signals that tell the tumor to grow and divide. EGFR mutation analysis: The EGFR gene makes a protein that regulates cell survival and cell division. A test called EGFR mutation analysis can be performed to help determine whether a patient is likely to respond to treatment with an EGFR inhibitor. PD-L1: PD-L1 is an immune-related biomarker that can be expressed on tumor cells. PD-L1 testing helps predict response to PD-L1 immunotherapies. Testing for the presence of these biomarkers can help doctors decide whether one treatment is more likely than another to work in their patient. This can: Improve health outcomes and provide safer treatments for patients Reduce unnecessary treatment and adverse effects Achieve health system efficiencies by only treating patients that are most likely to benefit from the drug
- An increasing number of treatments are personalized across a variety of therapeutic areas. While the highest number of personalized treatments are developed for oncology, it is also growing for other therapeutic areas such as psychiatry, infectious diseases, cardiology, endocrinology and neurology. With regard to oncology, cancer patients have seen a four-fold increase in their personalized treatment options in 10 years (Sources: IMS Institute for Healthcare Informatics, “Innovation in Cancer Care and Implications for Health Systems: Global Oncology Trend Report,” May 2014 (accessed May 2015); National Cancer Institute, “NCI Dictionary of Cancer Terms” (accessed May 2015)).
- An increasing number of treatments are personalized across a variety of therapeutic areas. While the highest number of personalized treatments are developed for oncology, it is also growing for other therapeutic areas such as psychiatry, infectious diseases, cardiology, endocrinology and neurology. With regard to oncology, cancer patients have seen a four-fold increase in their personalized treatment options in 10 years (Sources: IMS Institute for Healthcare Informatics, “Innovation in Cancer Care and Implications for Health Systems: Global Oncology Trend Report,” May 2014 (accessed May 2015); National Cancer Institute, “NCI Dictionary of Cancer Terms” (accessed May 2015)).
- An increasing number of treatments are personalized across a variety of therapeutic areas. While the highest number of personalized treatments are developed for oncology, it is also growing for other therapeutic areas such as psychiatry, infectious diseases, cardiology, endocrinology and neurology. With regard to oncology, cancer patients have seen a four-fold increase in their personalized treatment options in 10 years (Sources: IMS Institute for Healthcare Informatics, “Innovation in Cancer Care and Implications for Health Systems: Global Oncology Trend Report,” May 2014 (accessed May 2015); National Cancer Institute, “NCI Dictionary of Cancer Terms” (accessed May 2015)).
- At the present time, there is no clear and consistent pathway to introduce a biomarker test in Canada’s health system. This can create delays and uneven coverage in accessing new personalized medicines. Regulatory authorization: Biomarker tests first need to be authorized by Health Canada. There is, however, no specific process for a drug and its related biomarker test to be reviewed together by Health Canada. The drug is evaluated separately from the biomarker test, which is evaluated as a medical device. This can be a challenge in terms of coordinating and aligning the review process so that the drug and the associated test receive market authorization at the same time given that the regulatory review timelines for each of these components are different. Health Technology Assessment: The national health technology assessment agency CADTH has reviewed several targeted therapies, especially oncology therapies, with biomarker tests. However, there is not currently a national standardized process for determining the clinical utility and reimbursement rates for companion diagnostic tests. CADTH is currently working on developing a review process that will provide advice on public reimbursement of “companion diagnostics”. It plans to consult on this process and implement it in 2017. Quebec, which has its own health technology assessment agency INESSSS, has put in place a mandatory evaluation process for biomarker tests. However, there is no pathway to evaluate the drug at the same time as its related biomarker tests. Funding Decisions: Funding mechanism are often not well defined and vary from one province to another QC : has a central decision-making process for reimbursement which is based on the recommendations made by INESSS (i.e., Health Ministry decides on reimbursement of tests). ON: Cancer Care Ontario provides funding for biomarker tests that are related to cancer therapeutics. It has a separate process for determining reimbursement. Review of tests to determine funding is also conducted by the Ontario Health Technology Advisory Committee, which is part of Health Quality Ontario and by the Genetic Testing Advisory Committee established by the Ontario Ministry of Health. Health System Adoption: Ultimately, even when a biomarker test has been authorized by Health Canada and is reimbursed for funding, there can still be challenges in integrating the test into clinical practice. There can be reluctance in the medical community with regard to uptake or use of novel clinical tests. Physicians need to understand the information provided by the test and know how to integrate it into their decision making process. Patients need to know how they can benefit from novel tests, and to understand the implications of new information the tests can provide.
- SASKATCHEWAN The SKCA’s 2015-2020 Strategic Plan identified the development of a molecular oncology strategy as an initiative it would undertake in 2015-16 and has reported that it is working with health regions to introduce molecular testing for oncology diagnosis and treatment. Each health region oversees the specific lab services in its region. http://www.saskcancer.ca/adx/aspx/adxGetMedia.aspx?DocID=726,6,1,Documents&MediaID=53c617fe-aee2-46a9-b973-893737 09ddb6&Filename=Strategic+Plan+2015-2020+FINAL.pdf http://www.saskcancer.ca/Default.aspx?DN=53be3acb-a7fd-4e9f-926f-219b002000d6 MANITOBA One of the goals of the DSMB’s five-year strategic plan, Diagnostic Services Manitoba Strategic Plan 2016-2020: Results that Matter, is the creation of a provincial genomics strategy for molecular diagnostics and cytogenetics, which expands over three to five years. The plan identifies four operational strategies to achieve this goal: Develop a Provincial Genomics Testing Advisory Committee (GTAC), who will develop Manitoba’s Provincial Genomics Testing Strategy with the collaboration of key stakeholders; Plan, prioritize and implement molecular diagnostic tests in pathology – in particular, EGFR for lung cancer; Introduce next generation sequencing into the clinical laboratory (for BRCA1/2 and EGFR, among others); and Build relationships and develop clinical and research partnerships to transition testing to the clinical laboratory and develop funding opportunities and proposals. http://dsmanitoba.ca/wp-content/uploads/2015/07/DSM-Strategic-Plan-2016-2021-Final.pdf ONTARIO: In terms of broader cancer policy, Ontario is on its fourth multi-year cancer plan, Ontario’s Cancer Plan IV, 2015-2019, which sets out six system goals, each with their own strategic objectives (certain of which are below): Quality of life and patient experience across the care continuum; Safety of patients and caregivers, part of which will be to implement an accountability framework and performance management structure for pathology, among other areas, by 2019; Equity for patients, through providing advice to government on improving access to services for specific populations, including “equitable access to specialized services”; Integrated care across the continuum, involving standardized care plans for patients and increased availability of relevant patient clinical information to providers to support evidence-based decision-making; Sustainability of the cancer system, part of which involves a planned evaluation of drugs funded through the Provincial Drug Reimbursement Program to determine which provides the greatest benefit to patients and its corresponding impact on the healthcare system by 2019; and Effectiveness of cancer care, based on best evidence, in particular through the development of “a unifying strategy for personalized medicine for cancer care including personal and tumour genetics, and incorporat[ion of] recommendations into clinical practice”, with implementation beginning by 2019. https://cancercare.on.ca/common/pages/UserFile.aspx?fileId=333871
- So what do you need to know? Well, the uptake and diffusion of biomarkers is transformative and changes the way disease is identified and managed. However, integrating biomarkers into clinical practice faces several challenges which will need to be addressed to ensure optimal patient access to new targeted and specialized therapies. Challenges include… No clear, consistent pathway for introducing biomarkers in health system: Lack of a systematic approach for evaluating and funding biomarkers Inconsistent access to drugs and biomarkers based on different timelines in each province for reimbursement Challenge of ensuring test is in place simultaneously with drug funding Rapidly evolving knowledge on the role / place of biomarkers in treatment guidelines Lack of knowledge translation to patients on biomarker tests and their purpose Challenge for provinces of assessing and reimbursing multiple new entrant cancer drugs and related biomarker tests No evidence development pathways and data collection in health systems in Canada that would help collect data on new drugs and associated tests
- The illustration shows how a biomarker test is performed. The clinician will discuss the test and the purpose of the test with his patient. A tissue sample (biopsy) of the tumor will then be taken, and the clinician orders the biomarker test. If a patient has already had a biopsy, he or she may not have to get another one. The clinician may be able to see if the tumors are positive for certain biomarkers by testing a previous sample with a biomarker test. The biopsy is sent to a lab and is analyzed. The clinician will get the results and discuss treatment options with the patient based on these results. Patients can aim to learn more and engage with their health care team and/or patient group to better understand how biomarker tests can help shape their treatment. Key questions to consider include: 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? In this regard, I want to mention that the Canadian Cancer Survivor Network will be hosting a webinar on biomarkers on November 29th. Patients and patients groups can also get involved in personalized medicine policy and advocacy: work with health technology assessment agencies and payers to ensure that value assessments are patient-centered and that biomarker tests are reimbursed and included as part of patient care work with payers to ensure that emerging paying models are aligned with personalized medicine and that they recognize the improved health outcomes from personalized medicine In particular, patients and patient groups will get the chance to provide input on the new evaluation process for companion diagnostics that CADTH is developing in the coming months.
- The illustration shows how a biomarker test is performed. The clinician will discuss the test and the purpose of the test with his patient. A tissue sample (biopsy) of the tumor will then be taken, and the clinician orders the biomarker test. If a patient has already had a biopsy, he or she may not have to get another one. The clinician may be able to see if the tumors are positive for certain biomarkers by testing a previous sample with a biomarker test. The biopsy is sent to a lab and is analyzed. The clinician will get the results and discuss treatment options with the patient based on these results. Patients can aim to learn more and engage with their health care team and/or patient group to better understand how biomarker tests can help shape their treatment. Key questions to consider include: 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? In this regard, I want to mention that the Canadian Cancer Survivor Network will be hosting a webinar on biomarkers on November 29th. Patients and patients groups can also get involved in personalized medicine policy and advocacy: work with health technology assessment agencies and payers to ensure that value assessments are patient-centered and that biomarker tests are reimbursed and included as part of patient care work with payers to ensure that emerging paying models are aligned with personalized medicine and that they recognize the improved health outcomes from personalized medicine In particular, patients and patient groups will get the chance to provide input on the new evaluation process for companion diagnostics that CADTH is developing in the coming months.