houston january 27, 2018 - cancer research
TRANSCRIPT
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Houston January 27, 2018
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Brian Brewer Cancer Research Institute
WELCOME
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Our Host
A special thank you for hosting the Immunotherapy Patient Summit
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Our Sponsors
This event is made possible with generous support from:
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Our Promotional Partners
Addario Lung Cancer Foundation BrainUp Coalition for Clinical Trial Awareness Colon Cancer Alliance Dan L Duncan Comprehensive Cancer Center Fight Colorectal Cancer Focused Ultrasound Foundation FORCE GI Cancers Alliance
Thank you to those who helped promote the summit
Harris Health System Imerman Angels Immunotherapy Foundation Let Life Happen Melanoma Research Foundation MD Anderson Cancer Center National Ovarian Cancer Coalition Patient Empowerment Network Survivors Offering Support Sugarland US TOO
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Our Guest Faculty
Scientific Experts
Charles Drake, M.D., Ph.D. Columbia University Medical Center
Carlos Ramos, M.D., Ph.D. Baylor College of Medicine
Andrew Sikora, M.D., Ph.D. Baylor College of Medicine
Sumit Subudhi, M.D., Ph.D. MD Anderson Cancer Center
Jun Zhang, M.D. Baylor College of Medicine
Patient Experts
Dale Biggs Squamous Cell Carcinoma Katherine (K.C.) Dill Lung Cancer Janie Ferling Melanoma
Adam Requena Mesothelioma
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Schedule of Events
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IMMUNOTHERAPY BASICS
Charles Drake, M.D., Ph.D. Director GU Medical Oncology Co-Director Immunotherapy Program Associate Director for Clinical Research Professor of Oncology Herbert Irving Cancer Center at Columbia University
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• T Cells
• Activating T Cells In Tumors • Activating T Cells Outside of Tumors
• Combination Immunotherapy
Outline
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CD8 T Cells Are Born to Kill
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BrownStaining=CD8TCells
Killer T Cells in Tumors
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Kidney Tumor
CD8 T cell
MHC
PD-1
TCR
- - -
- - -
+ + +
PD-1 PD-L1
PD-L1
TumorAn7gen
CD8TCellsareBeingHeldinCheck(Exhausted)WHENPD-L1isExpressed
Why Are Those Killer T Cells Not Killing?
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“Exhausted” Tumor Infiltrating T Cell
Anti-PD-1 or Anti-PD-L1
Blocking PD-1 (or PD-L1) Allows T Cells to Regain the Capacity to Kill
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Drake CG et al Journal of Clinical Oncology, 2013 ASCO Annual Meeting Abstracts. Vol 31, No 15_suppl (May 20 Supplement), 2013: 4514 ASCO 2013
ß6months
Rapid Tumor Shrinkage (in some patients) Evidence of Killing
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Anti-PD-1 or Anti-PD-L1
“Exhausted” Tumor Infiltrating T Cell
Blocking PD-1 (or PD-L1) Allows T Cells to Proliferate
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Drake CG et al Journal of Clinical Oncology, 2013 ASCO Annual Meeting Abstracts. Vol 31, No 15_suppl (May 20 Supplement), 2013: 4514 ASCO 2013
ß6months
Temporary Tumor Growth Before Shrinking Evidence of T Cell Proliferation in Patients
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Drake CG et al Journal of Clinical Oncology, 2013 ASCO Annual Meeting Abstracts. Vol 31, No 15_suppl (May 20 Supplement), 2013: 4514 ASCO 2013
ß6months
Long Term Responses Off Treatment Evidence for T Cell Memory?
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2002: Surgery to remove kidney cancer
2004: Relapse with multiple lung tumors Treated on sequential clinical trials
2008: Multiple metastatic cancer lesions in lungs, bone, soft tissue
Not Just a Line on A Graph ….
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2008: Enrolled in Phase I Trial of Experimental Immune Drug
March 2 month evaluation
January First treatment
2010: Complete Response
July No viable tumor
§ Patient received 3 study treatments
§ Limited side effects
§ Rapid treatment response
§ Cancer-free for 8+ years
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BrownStaining=CD8TCells
Other Approaches
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T cells isolated
from patient
T Cells Expanded
And Activated
T Cells Re-Infused
MORE T Cells = Better Adoptive Transfer
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Natural T Cell Receptor
CD3
ζ
α β
ε ε
ζ
γ δ
ζ
Extracellular
Intracellular
Chimeric Antigen Receptor
High Affinity Tumor binding domain
Signaling domain
Courtesy of. Carl June, U Penn
BETTER T Cells = Better Chimeric Antigen Receptor T Cells (CAR-T)
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This Means CAR-T Cells
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Brown Staining = CD8
Kidney Tumor with T Cells Kidney Tumor
Not All Tumors Have T Cells: Combination Approaches
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CD8 T cell Tumor cell MHC TCR
+ + +
Supressive Factors
Regulatory CD4 T Cell
(FoxP3+)
CTLA-4 + + +
CTLA-4 + + +
- - - - -
Anti-CTLA-4
The Tumor Microenvironment is a VERY Unfriendly Place
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Wolchok JD et al. N Engl J Med 2013;369:122-133
Hepatitis Colitis
Nephritis
Dermatitis
Combining Two Immunotherapies (Anti-PD-1 and Anti-CTLA-4) Can Sometimes Increase Toxicity
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Combination Immunotherapy Can Be VERY Active
Wolchok JD et al. N Engl J Med 2013;369:122-133
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www.newlinkgene7cs.com
Other Ways Tumors Resist the Immune System
IDO
• Breaksdowntryptophan
• Tryptophanisessen7alforTcellfunc7on
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Zakharia,Y–AACRAnnualMee7ng2017
Combining T Cell Re-Activation (anti-PD-1) With IDO Inhibition
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Nature.2011480:480-9
Targets on T Cells
Targets in the Tumor
Microenvironment
• IDO • Adenosine / A2A
Receptor • TGF-Beta • Interleukin 8 • CSF-1 • NLRP3
Our Challenge
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https://www.cancerresearch.org/patients/what-is-immunotherapy
https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy.html
https://www.cancer.gov/research/areas/treatment/immunotherapy-using-immune-system
https://www.mdanderson.org/treatment-options/immunotherapy.html
https://www.pennmedicine.org/cancer/navigating-cancer-care/treatment-types/immunotherapy
Additional Information: Useful resources about cancer immunotherapy
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LATEST RESEARCH UPDATE
Panel Discussion
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Scientific Panel
Moderator
Charles Drake, M.D., Ph.D.
Panel
Carlos Ramos, M.D., Ph.D. Blood Cancer & HPV-Associated Cancers
Andrew Sikora, M.D., Ph.D. Head and Neck Cancer
Sumit Subudhi, M.D., Ph.D. Urologic Cancer
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PATIENT PERSPECTIVE
Janie Ferling Melanoma Survivor
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LUNCH AND NETWORKING
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DEMYSTIFYING CLINICAL TRIALS
Brian Brewer Cancer Research Institute
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What Are Clinical Trials?
• Research studies that involve people
• Designed to answer specific questions about new and existing treatments
• Aim to improve treatments and the quality of life for people with disease
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Getting from Discovery to Approval
Source:AppliedClinicalTrials.com
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What Are Clinical Trial Phases?
Pa#entResource,“UnderstandingClinicalTrials:AGuideforPa7entsandTheirFamilies”
Is the treatment safe?
Phase 1
Does it work?
Phase 2
Does it work better?
Phase 3
Purpose: • First study in humans • Find best dose, delivery
method, and schedule • Monitor for side effects • Determine safety
Number of people: 20-100
Purpose: • Look for effect on specific
type(s) of cancer • Continue monitoring for
side effects and safety
Number of people: 100-500
Purpose: • Compare new treatment
(or new use of a treatment) with current standard treatment
• Determine risk vs. benefit Number of people: 1,000-5k+
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Pros and Cons of Clinical Trials
Potential Advantages Potential Disadvantages
Pa#entResource,“UnderstandingClinicalTrials:AGuideforPa7entsandTheirFamilies”
Access to best possible care
Receiving new drugs before they’re widely available
Close monitoring by medical team
Chance to play active role in healthcare and research
Help future generations
Unknown side effects or risks
Unknown benefits—drugs may not work as intended
Not all patients may benefit
Frequent tests and clinic visits
Possible need to travel to trial sites
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Questions to Ask Before Volunteering
• Why is this trial being done?
• Why is it believed that the treatment being studied may be better
than the standard treatment?
• What are my other options (standard treatments, other trials)?
• How did patients do in any previous studies of this treatment?
• How will the doctor know if treatment is working?
• How long will the trial last?
Pa#entResource,“UnderstandingClinicalTrials:AGuideforPa7entsandTheirFamilies”
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Questions to Ask Before Volunteering
• Can I continue to receive this treatment after the trial ends?
• What kinds of procedures or tests are involved?
• What impact with the trial have on my daily life?
• Will I have to travel for treatment? Will I be compensated?
• How often will I need to travel to receive treatment?
• Will I be hospitalized as part of the trial?
• What costs (if any) will be my responsibility to pay?
Pa#entResource,“UnderstandingClinicalTrials:AGuideforPa7entsandTheirFamilies”
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Getting into a Clinical Trial Isn’t Always a Given
Trials are designed to ask specific questions, and must adhere strictly to entry criteria to ensure data is accurate and meaningful.
Common criteria include: • cancer type or stage • treatment history • genetic factors • age • medical history • current health status
This also helps ensure patients who could be made worse by treatment are not exposed to the risk.
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Clinical Trials: Myth versus Fact
I might only get placebo (“sugar pill”) instead of treatment.
Fact: Placebos are rarely used and never given in the absence of some form of treatment.
Pa#entResource,“UnderstandingClinicalTrials:AGuideforPa7entsandTheirFamilies”
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Clinical Trials: Myth versus Fact
Trials are only for people who have run out of treatment options
(a “last resort”).
Fact: Clinical trials are designed for people with cancer of all types and stages.
Pa#entResource,“UnderstandingClinicalTrials:AGuideforPa7entsandTheirFamilies”
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Clinical Trials: Myth versus Fact
I need to travel to a large hospital or cancer center to participate
in a clinical trial.
Fact: Trials take place at local hospitals, cancer centers, and doctors’ offices in all parts of the
country, in both urban and rural areas.
Pa#entResource,“UnderstandingClinicalTrials:AGuideforPa7entsandTheirFamilies”
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Clinical Trials: Myth versus Fact
My health insurance doesn’t cover the cost of care in a
clinical trial.
Fact: Doctor visits, hospital stays, and certain testing procedures may be covered by insurance.
Research costs are typically covered by the trial
sponsor.
Pa#entResource,“UnderstandingClinicalTrials:AGuideforPa7entsandTheirFamilies”
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Clinical Trials: Myth versus Fact
Signing a consent form “locks” me into staying in a trial.
Fact: You are free to change your mind for any reason about participating in a trial anytime before
or during a trial.
Pa#entResource,“UnderstandingClinicalTrials:AGuideforPa7entsandTheirFamilies”
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Clinical Trials: Myth versus Fact
I will be made to feel like a “guinea pig” experiment.
Fact: The overwhelming majority of trial participants say they were treated with dignity and
respect, and report having had a positive
experience in a trial.
Pa#entResource,“UnderstandingClinicalTrials:AGuideforPa7entsandTheirFamilies”
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Clinical Trials: Myth versus Fact
Clinical trials aren’t safe.
Fact: Safeguards including an Institutional Review Board, Data and Safety Monitoring Board, and an
ongoing informed consent process ensure
patients’ rights and safety are protected.
Pa#entResource,“UnderstandingClinicalTrials:AGuideforPa7entsandTheirFamilies”
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A Word About Informed Consent
Informed consent = having all the facts before and during a trial
• Study purpose
• Length of time of the study
• Predictable risks
• Possible benefits
• Expectations
• Patient’s rights
• Treatment alternatives
• Patient health monitoring
• Safeguards in place
• How to withdraw from study
Be bold in asking for details. It’s YOUR treatment plan.
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How Can I Find a Clinical Trial?
• Ask your doctor
• Ask another doctor if necessary…
• Contact a patient advocacy organization
– Seek assistance from a clinical trial navigator, if offered
– CRI Clinical Trial Finder: 1 (855) 216-0127
• Search online
– https://www.cancerresearch.org/patients/clinical-trials
– https://clinicaltrials.gov/
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IMMUNOTHERAPY CLINICAL TRIALS
Panel Discussion
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Patient Panel
Moderator
Brian Brewer
Panel
Dale Biggs
Squamous Cell Carcinoma Katherine (K.C.) Dill
Lung Cancer
Adam Requena
Mesothelioma
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BREAKOUT SESSIONS
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Breakout Rooms
Blood Cancer & HPV-Associated Cancers N317 Carlos Ramos, M.D., Ph.D.
Head and Neck Cancer M112 Andrew Sikora, M.D., Ph.D.
Jun Zhang, M.D.
Urologic Cancer McMillian Sumit Subudhi, M.D., Ph.D.
General Immunotherapy Kleberg (Here) Charles Drake, M.D., Ph.D.
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Our Sponsors
This event is made possible with generous support from:
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Our Host
A special thank you for hosting the Immunotherapy Patient Summit
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Our Promotional Partners
Addario Lung Cancer Foundation BrainUp Coalition for Clinical Trial Awareness Colon Cancer Alliance Dan L Duncan Comprehensive Cancer Center Fight Colorectal Cancer Focused Ultrasound Foundation FORCE GI Cancers Alliance
Thank you to those who helped promote the summit
Harris Health System Imerman Angels Immunotherapy Foundation Let Life Happen Melanoma Research Foundation MD Anderson Cancer Center National Ovarian Cancer Coalition Patient Empowerment Network Survivors Offering Support Sugarland US TOO
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Houston January 27, 2018