Panel on Access
- 1. Florida Society of Clinical Oncology: The Voice of Oncology in Florida Emerging Immune-Oncology Therapies Enhancing The Patient Experience Through Improving Access Issues Keith Knutson, PhD Professor of Immunology, Mayo Clinic - Florida Speaker Lea Ann Biafora, MS, RN, OCN Oncology Clinical Consultant, Humana Moderator Panelists Katie Zacher, MBA Director of Revenue, Florida Hospital Don Champlain, RN, MHA Associate Director for Care Management, Florida Cancer Specialists Evania Nichols Key Account Manager - Florida, Janssen Biotech
- 2. Florida Society of Clinical Oncology: The Voice of Oncology in Florida http://www.asco.org/sites/new-www.asco.org/files/content-files/research-and- progress/documents/2016-socca-infographic.pdf 2
- 3. Bridge Between Patient and Provider BarrierstoCancerCare •Financial and insurance concerns (working, insurance (co-pays, co- insurance, deductible), prescription coverage; housing (utilities, food, transportation) •Clinical trial opportunities •Patient/Physician Engagement and/or Communication •Support services during treatment •Psychosocial concerns: cultural, religious and person values ComplexDiseaseProcess •Understanding testing for detecting cancer •Understanding the cancer diagnosis and extent of disease •Need for care coordination •Diagnostic testing and on-going status checks ComplexTreatment •Informed decision making with treatment options •Treatment planning: individualized drug regimen choice based on evidence- pathways •Treatment oversight and care coordination •Symptoms, side effects and quality of life 3
- 4. Florida Society of Clinical Oncology: The Voice of Oncology in Florida • Review the evolution of immunotherapeutics. • Review the mechanism of action and potential side effects to immunotherapeutics used in cancer. • Discuss key access barriers related to immunotherapeutics. • Discuss patient resources that address access barriers in different settings. 4
- 5. ©2014 MFMER | slide-5 Immune-based Therapies: A Focus on Access Keith L. Knutson Professor of Immunology Director, Cancer Research, Mayo Clinic Florida
- 6. ©2014 MFMER | slide-6 Conflict of Interest • TapImmune, Inc. • Cancer Vaccines – Jacksonville, FL • Scientific Advisory Board (unpaid) • Several Patent Licensing Agreements (Mayo) • Kiromic, Inc. • Cancer Vaccines – Lubbock, TX • Scientific Advisory Board (Stock) • Intelligent Immunity, Inc. • Cancer Vaccines – Jacksonville, FL • Scientific Advisory Board (Unpaid) • Founder (Stockholder) • Antigen Express, Inc. • Cancer Vaccines – Cambridge, MA • Scientific Advisory Board (Paid)
- 7. ©2014 MFMER | slide-7 textbookofbacteriology.com Cells of the Immune System
- 8. ©2014 MFMER | slide-8 CD4 “helper” T cells •Inflammation (macrophages and neutrophils) •Antibodies •Induce/Enhance cytotoxic T cells •Immune-surveillance •Epitope-spreading •Cytokines CD8 “cytolytic” T cells •Tumor lysis B cells •Antibodies •Signaling •ADCC •Complement The adaptive immune response
- 9. ©2014 MFMER | slide-9 1890 1956 1973 1997 2000 2002-3 2010 2012 Coley’s Toxins tried in humans Today Identification of tumor antigens The first monoclonal antibody, Rituximab is approved to treat B cell lymphoma Adoptive cell therapy with TILs is first described Immunotherapy for cancer: 100 years of science Dendritic cells are discovered 1978 • BCG is first studied as a therapy • IL-2 is discovered • Tumor-specific antibodies are discovered 1988 BCG approved for bladder cancer 1990 1998 • IL-2 approved to treat metastatic melanoma • Trastuzumab is approved for breast cancer Gemtuzumab ozogamicin, an antibody toxin conjugate is approved for AML Two antibody/radioisotope conjugates, Ibritumomab tiuxetan and Iodine I 131 Tositumab are approved First therapeutic cancer vaccine, sipuleucel, is approved by the FDA 2011 Ipilimumab is approved for melanoma Several clinical studies demonstrate the therapeutic activity of PD-1/PD-L1 blockade 2014 Nivolumab and Pembrolizumab are approved for advanced melanoma
- 10. ©2014 MFMER | slide-10 Clinical Trial Sponsorship • Physicians • Scientists • Medical Institutions • Foundations • Voluntary Groups • Pharmaceutical Companies • Federal Agencies (cooperative group research) • NIH • NCI (ACRIN is funded through the NCI as a cooperative group) • DOD • VA
- 11. ©2014 MFMER | slide-11 Phase 0 • Recent designation for exploratory, first-in-human trials • Expedite the development of promising therapeutic or imaging agents • Involve the administration of single sub therapeutic doses to a small number of subjects (10-15). • Preliminary data on the pharmacokinetic and pharmacodynamic properties and mechanism of action. Phase I • Typically first step in testing in humans. • Researchers look for safety and potentially harmful side effects. • Usually include only a limited number of human subjects (20- 80). • This phase of testing usually takes several months. • Multiple different kinds of Phase I trials. • Preliminary data on efficacy and pharmacology.
- 12. ©2014 MFMER | slide-12 Phase II • Once a drug has shown to be safe, then it must be tested for efficacy. • This phase may last from several months to a few years. • Usually involves several hundred patients • Most of these trials are randomized trials Phase III • Randomized control trials (300-3000). • Compare the results of the patients on the experimental trial to those patients utilizing standard diagnostic studies, standard treatment, or placebo. • Multi-center trials. • Many phase III trials are randomized and blinded.
- 13. ©2014 MFMER | slide-13 BC141410: FRa Vaccination to Prevent Progression of Triple Negative Breast Cancer Stages IIb/III TNBC Placebo N=93 Vaccine N=187 Conventional Therapy • Multicenter Phase II Trial to Test Whether Vaccine Prevents Recurrence in Patients Diagnosed and Treated for TNBC FRa is preferentially overexpressed in TNBC
- 14. ©2014 MFMER | slide-14 Complex Eligibility Specification Limits Access to Most Advanced Clinical Trials: Example of Phase II of Vaccine Trials • No evidence of disease. • Within one year of standard of care treatment. • Recurrent cancer ineligible. • Existing or preexisting autoimmune disease. • Target expression Side Effects of Cancer Vaccination • Fatigue • Injection site reactions • Nausea
- 15. ©2014 MFMER | slide-15 aBased on small subgroups of patients with HER2-positive breast cancer; bDDFS; CTx, chemotherapy; AC, doxorubicin, cyclophosphamide; P, paclitaxel; T, docetaxel; Carbo, carboplatin; V, vinorelbine; CEF, cyclophosphamide, epirubicin, 5-fluorouracil DFS benefit for Trastuzumab in Adjuvant Trials 3 4 5 4 Gianni et al 2008; Gianni et al 2009; Joensuu et al 2009; Slamon et al 2006; Perez et al 2007; Smith et al 2007; Spielmann et al 2007; Perez 2005 3 3 Median follow-up, years/HRDFS benefit B-31 / N9831 ACPH HERA CTxH 1 year FinHera VH / THCEFb PACS-04a CTxH 1 year BCIRG 006 ACTH TCarbo H n=231 n=528 NOAH CTx / HH 1 year 3 0 1 2Favors Trastuzumab Favors no TrastuzumabHR Chemotherapy plus Trastuzumab administered for 1 yr represents the standard of care On average, this treatment induces a 50% reduction in HR for relapse in all subgroups of pts, especially concurrent with chemo N9831 ACP H 1.5 0.87 0.48 0.64 0.61 0.67 0.86
- 16. ©2014 MFMER | slide-16 Proposed mechanisms of action of trastuzumab
- 17. ©2014 MFMER | slide-17 Trastuzumab – Side Effects • Fever • Nausea • Vomiting • Diarrhea • Infections • Increased cough • Headache • Fatigue • Shortness of breath • Rash • Low white and red cells • Muscle pain MOST COMMON SEVERE • Reduced heart function • Congestive heart failure • Swelling of the lungs • Severe shortness of breath • Fetal death
- 18. ©2014 MFMER | slide-18 Discovery Medicine Adoptive T cell therapy with CAR T cells LIMITATIONS • Production of a recombinant transgenic construct to modify T cells from patient. • High cost expansion infrastructure to grow T cells
- 19. ©2014 MFMER | slide-19 Side effects associated with CAR T cell therapy Mol Therapy 2016 LIMITATION • Tumor must have specific target expressed
- 20. ©2014 MFMER | slide-20 The Checkpoint Blockade Revolution Lymphomation.org
- 21. ©2014 MFMER | slide-21 Side Effects of Immune Checkpoint Inhibitors Cancergrace.org
- 22. ©2014 MFMER | slide-22 Other Factors that Limit Access of Patients to Clinical Trials • Insurance: No formal agreements or industry policy on what components of a clinical trial are covered by insurance companies. Limits activating trials. • Awareness: Community physicians are unaware of trials. • Resources: Community physicians and clinics lack resources to become involved in clinical trials. • Adverse event risk: Trials are not attractive to potential participants. • Industry interests: Early testing is regulated by company because of strategic interests and limited resources.
- 23. ©2014 MFMER | slide-23 • Increase research transparency • Help people find trials ClinicalTrials.gov can be searched in real time to find enrolling and completed studies including: • Conditions • Interventions • Outcome measures • Sponsors/collaborators • Locations • Phases • Dates (Start and Completion) • Results
- 24. ©2014 MFMER | slide-24 http://www.ClinicalTrials.gov
- 25. ©2014 MFMER | slide-25
- 26. Florida Society of Clinical Oncology: The Voice of Oncology in Florida Access 26
- 27. Florida Society of Clinical Oncology: The Voice of Oncology in Florida • Financial and insurance concerns (working, insurance: co-pays, co-insurance, deductible), prescription coverage; housing (utilities, food, transportation) • Clinical trial opportunities • Patient/Physician Engagement and/or Communication • Support services during treatment • Psychosocial concerns: cultural, religious and person values Access Barriers Related to Immunotherapeutics in Cancer Care 27
- 28. Florida Society of Clinical Oncology: The Voice of Oncology in Florida Do You Know Your Coverage ? 1. Coverage for treatment regimens are based upon what guidelines? A. FDA B. NCCN C. Payor developed guidelines D. Combination of all or some of the above 28
- 29. Florida Society of Clinical Oncology: The Voice of Oncology in Florida Do You Know Your Coverage ? 2. Drug Replacement Programs are available for certain drugs if a patient is A. Uninsured B. Underinsured C. Insured D. All of the Above 29
- 30. Florida Society of Clinical Oncology: The Voice of Oncology in Florida Do You Know Your Coverage ? 3. Financial Assistance through a variety of Foundation/Programs are available to: A. Uninsured B. Insured C. Underinsured D. All of the Above 30
- 31. Florida Society of Clinical Oncology: The Voice of Oncology in Florida Do You Know Your Coverage ? 4. If you are not uninsured or underinsured, you are not able to obtain financial assistance. A. True B. False 31
- 32. Florida Society of Clinical Oncology: The Voice of Oncology in Florida Financial Toxicity of Cancer • 32% of cancer patients report cancer-related financial problems. • 23% of cancer patients reporting that they postponed recommended health care due to cost. • Cancer patients are 2.65x more likely to go bankrupt than people without cancer. 32
- 33. Florida Society of Clinical Oncology: The Voice of Oncology in Florida Financial Toxicity of Cancer Population Median Annual Household Income Average Annual Cost of Cancer Cost of Cancer as Percentage of Average Household Income Under 65 years $57,353 $16,213 28% 65 and older $33,848 $16,441 49% 33
- 34. Florida Society of Clinical Oncology: The Voice of Oncology in Florida Patient Propensity to Pay, by Deductible Size 10% 20% 30% 40% 50% 60% 70% 80% $500 - $999 $1,000 - $2,000 $2,001 - $3,500 $3,501 - $5,000 $5,001 - $6,350 34
- 35. Florida Society of Clinical Oncology: The Voice of Oncology in Florida Challenges within Immunotherapy • What are some ways nurse navigators can keep abreast of new classes and expanded indications of immunotherapeutic agents? • How best to address the right drug/person when patients ask about candidacy for immunotherapy for treatment and/or clinical trial? • How do we coordinate care as patient life expectancies increase as a result of immunotherapy? Access Barriers Related to Immunotherapeutics in Cancer Care • Would you share best practices on how your institution addresses: – Financial and insurance concerns (working, insurance prescription coverage; housing (utilities, food, transportation) – Clinical trial opportunities – Patient/Physician Engagement and/or Communication – Support services during treatment – Psychosocial concerns: cultural, religious and person values Roundtable Discussion on: 35
- 36. Florida Society of Clinical Oncology: The Voice of Oncology in Florida Discuss patient resources that address access barriers in different settings. • Cancer Care: 2016 Patient Access and Engagement Report https://media.cancercare.org/accessengagementreport/Highlights-SlidesMay2016pdf.pdf • Cancer Research Institute: TheAnswerToCancer.org http://www.theanswertocancer.org/ • Society for Immunotherapy of Cancer: Free patient resource on Understanding Cancer Immunotherapy and Immunotherapy for the treatment of Melanoma. www.sitcancer.org • The Advocacy Connector www.advocacyconnector.com 36
Editor's Notes
- #26: Screen shot of ClinicalTrials.gov showing Full Text View