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Jeffrey S. Weber, MD, PhD
Director, Donald A. Adam
Comprehensive Melanoma Research Center
Senior Member, Moffitt Cancer Center
Professor and Associate Chair,
Department of Oncologic Sciences
University of South Florida
Tampa, FL
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Alexander M. M. Eggermont, MD, PhD
Department of Surgical Oncology
Erasmus University Medical Center
Daniel den Hoed Cancer Center
Rotterdam, The Netherlands
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CME-Accredited Webcasts, Presentation and Audio Downloads, and i-Tunes Podcast Downloads
6 presentations from the live course
The Next Generation of Therapy for Managing Melanoma Patients: CTLA-4 Blockade, Questions, Clinical Recommendations, and Clinical Cases
held in Chicago, IL on June 6, 2010
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You may participate in any or all of the sessions for CME credit or a Certificate of Attendance after you review the required ACCME (Accreditation Council on Continuing Medical Education) information on this page.
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Menu
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Overview of This CME-Accredited Educat
ional Activity
Your Options for Methods of Participation are:
- View and/or listen to any of the sessions (listed below) via an Adobe Flash Webcast
- Download any slides as Adobe Acrobat files
- Download any audio only as MP3s or Podcasts
- Request a DVD-ROM of all sessions
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Sessions can be individually reviewed for credit. You can participate in as few or as many as you desire.
CME-Accredited Educational Activity Dates and Time to Complete
Date of release: September 1, 2010
Date expires (CME credit will not be avaliable): September 1, 2011
Average time to complete each individual session: 20 minutes
Time to complete entire activity: 2 hours
Overview
This activity has been developed to provide clinicians with the most up-to-date clinical data and knowledge regarding the practical, clinical aspects of using CTLA-4 blockade immunotherapy for treating melanoma. CTLA-4 blockade is an entirely new class of therapy and is quite different from other "targeted therapies" in many aspects, beginning with its mechanism of action. Anti-CTLA-4 therapy is also associated with some novel efficacy endpoint measurements, unique patient response patterns and immune-related but manageable adverse events, which also help guide therapy as predictors of outcomes. The clinical benefits, efficacy and safety of anti-CTLA-4 therapy for melanoma are reviewed in a practical, "how to use this therapy" instructional and interactive symposium format.
A faculty consisting of scientific and clinical melanoma experts from the USA and Europe will present, review, and discuss how to employ anti-CTLA-4 therapy into their treatment strategies for melanoma. They will address the usage of this novel immunotherapy from several perspectives that are unique to this class of agents. The faculty will explain the science behind anti-CTLA-4 therapy, and how it acts upon the immune system, not on the malignancy, review the key clinical data to date with both anti-CTLA-4 drugs, review the unique adverse events -- immune-related Adverse Events (irAEs) caused by anti-CTLA-4's effect on the immune system, but more importantly how to successfully manage these irAEs, and then review the increasingly important biomarkers used in conjunction with anti-CTLA-4 therapy for treating melanoma.
Before the activity begins, a pre-activity educational assessment consisting of approximately eight patient care treatment-strategy questions with multiple-choice answers will be conducted to determine how you currently treat your patients in order to determine a baseline of current medical hematologists' practices.
Educational Needs Summary
In the USA, the estimated incidence of melanoma for 2009 was 68,720 people with an expected 8,650 deaths that year from this malignancy. The incidence of melanoma continues to increase as a result of higher exposure to ultraviolet light. The incidence of melanoma in populations of Caucasians in other countries is generally similar to that in the USA as a percentage of the population, and in most countries the incidence is increasing annually by a few percent.
Dacarbazine is currently the only cytotoxic agent approved for use in the USA for advanced melanoma. And interleukin-2 (IL-2) and interferon-alfa2b are the only approved immunotherapeutic agents for melanoma in the USA. Despite the commercial availability of numerous agents to treat melanoma, standard therapy for this malignancy today is considered experimental. The treatment guidelines of the National Comprehensive Cancer Network specify to use an experimental therapy by enrolling a patient in a clinical trial for treatment of melanoma.
Historically, there have been several attempts to utilize immunotherapy to treat any of a number of malignancies. William Coley in 1890, administered bacterial products for treating advanced malignancies and demonstrated significant responses. However, the widespread use of immunotherapy as an anticancer therapy emerged when IL-2 demonstrated some efficacy in the 1980's. Immunotherapy until now, however, has had only limited success for treating patients with melanoma.
The limitations of effectively utilizing immunotherapy for melanoma are derived from tumor-induced mechanisms of immune evasion that render the host tolerant of tumor antigens. Melanoma, for example, inhibits the maturation of antigen-presenting cells, preventing full T-cell activation and downregulating the effector antitumor immune response. Several novel immunotherapies are currently in clinical testing for melanoma. These include human antibodies that block Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) and other immunotherapeutic agents affecting different components of the immune system. CTLA-4 blockade with an antibody is the immunotherapy therapy for melanoma that is furthest along in clinical development.
Currently, there are two fully human anti-CTLA4 MAbs that have been extensively evaluated in the clinic for the treatment of melanoma. These two MAbs have somewhat different pharmacokinetic and pharmacodynamic properties.
Tremelimumab
One of these two MAbs is tremelimumab, a fully human immunoglobulin G-2 anti-CTLA4 MAb. Tremelimumab has been studied in two large clinical trials in patients with metastatic melanoma: a Phase III randomized trial of tremelimumab versus dacarbazine or temozolomide in previously untreated patients with advanced melanoma and a Phase II trial of tremelimumab in previously treated patients with advanced melanoma. However, in 2008 the clinical development of tremelimumab for the treatment of melanoma was halted. But in January 2010 it was announced that a new clinical development program for tremelimumab for advanced melanoma is scheduled to begin in 2010 or 2011.
Ipilimumab
The other anti-CTLA-4 MAb is Ipilimumab (MDX-010; Medarex Inc. / Bristol-Myers Squibb) an immunoglobulin G-1 anti-CTLA4 MAb. There are numerous completed and ongoing Phase II and Phase III trials with ipilimumab for melanoma. Ipilimumab has been used as monotherapy or combined with other therapies, including cytokines, vaccines and chemotherapy. Phase III registration trials for ipilimumab in melanoma are complete and it is possible the US Food and Drug Administration might approve ipilimumab for treating melanoma in 2010 or 2011.
The following is list of all sessions
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Activity Agenda |
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Scientific and clinical data supporting CTLA-4 blockade: Innovative and effective immunomodulation
Alexander M. M. Eggermont, MD, PhD |
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Immune-related response criteria: Case histories
Jeffrey S. Weber, MD, PhD |
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Immune-related adverse events associated with CTLA -4 blockade: Perspectives from clinicians
F. Stephen Hodi, MD |
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Which biomarkers correlate with benefit from CTLA-4 blockade?
Jedd D. Wolchok MD, PhD |
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Challenging clinical case studies: Correlating irAE s and biomarkers with outcomes.
Jeffery S. Weber, MD, PhD |
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Questions from the audience
Faculty and Audience |
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Educational Objectives
At the conclusion of all of these enduring materials, you should be able to:
- Compare and contrast the new scientific and clinical data supporting the utilization of CTLA-4 blockade therapy for the treatment of melanoma.
- Devise strategies to successfully manage the different melanoma patient response patterns using CTLA-4 blockade therapy.
- Devise strategies to successfully manage the unique side effects or immunerelated Adverse Events (irAEs) resulting from CTLA-4 blockade therapy.
- Determine how to best utilize the various biomarkers and correlates with outcome, including IrAEs, to provide the optimal care for patients with melanoma.
Target Audience
This symposium is designed for medical oncologists, hematologist/oncologists, dermatologists, and other clinicians who care for and manage patients with melanoma. Fellows, nurses, nurse practitioners, physician assistants and pharmacists who are also involved in the care of patients with melanoma are also invited to attend.
CME Accreditation & Credit Designation
The Oncology Learning Center is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
The Oncology Learning Center designates this educational activity for a maximum of 2 AMA PRA Category 1
Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
CME Certificate or Certificate of Participation
The relevant section(s) of the Evaluation Form pertaining to the session(s) of the enduring materials you have viewed or listened to, and the Request for Credit Form must be completed and submitted to the Oncology Learning Center following your participation in the enduring material educational activity to obtain CME credit. Physicians and other participants will be able to print their certificates after they complete these Forms.
Disclosure of Conflicts of Interest
In accordance with the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support, educational programs sponsored by the Oncology Learning Center must demonstrate balance, independence, objectivity, and scientific rigor. All faculty, authors, editors, and planning committee members participating in an OLC-sponsored activity are required to disclose any relevant financial interest or other relationship with the manufacturer(s) of any commercial product(s) and/or provider(s) of commercial services that are discussed in an educational activity. |
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Faculty Disclosures
It is the policy of the Oncology Learning Center, Inc. (OLC) to ensure that all of its educational activities and materials are of the highest quality, and are balanced, objective, independent, free of commercial bias, and planned and developed with scientific rigor with strict adherence to all Accreditation Council for Continuing Medical Education (ACCME) rules and policies. The OLC evaluates all content, faculty and faculty disclosures for any potential conflicts of interest. Should any conflicts of interest be identified these conflicts are resolved in advance of the educational activity by independent peer reviewers who are experts in the subjects of the educational activity.
All faculty and OLC staff participating in the content, planning or implementation of an educational CME activity are required to disclose to the audience of the educational activity any relevant financial relationships or interests and to assist in the resolution of any conflict of interest that may arise from the relationship(s) or interest(s). It is also the policy of the OLC to require all faculty presenters to make a meaningful disclosure to the audience of their discussions of unlabeled or FDA unapproved drugs, products, tests or devices. This information will be available as part of the educational activity and related material.
The following faculty and OLC staff have reported real or potential relevant conflicts of interest and these conflicts have been resolved, prior to this educational activity through a peer-review process by two medical oncologists who have had no affiliation with this educational activity other than the peer review process. This is documented on this page immediately following the financial disclosures below.
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Jeffrey S. Weber, MD, PhD
Consultant: Advisory Boards Only
Contracted Research: Moffitt Cancer Center
I intend to reference unlabeled/unapproved uses of drugs or products in my presentation
Alexander M. M. Eggermont, MD, PhD
Consultant: Schering Plough, BMS, Roche
F. Stephen Hodi, MD
Consultant: BMS
Contracted Research: BMS, Pfizer
I intend to reference unlabeled/unapproved uses of drugs or products in my presentation.
Jedd D. Wolchok, MD, PhD
Consultant: BMS
I intend to reference unlabeled/unapproved uses of drugs or products in my presentation.
OLC Staff
We have no real or apparent conflicts of interest to report. |
Faculty Affiliations
Jeffrey S. Weber, MD, PhD (Co-Chair)
Director, Donald A. Adam
Comprehensive Melanoma Research Center
Senior Member, Moffitt Cancer Center
Professor and Associate Chair,
Department of Oncologic Sciences
University of South Florida
Tampa, FL
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Alexander M. M. Eggermont, MD, PhD (Co-Chair)
Department of Surgical Oncology
Erasmus University Medical Center
Daniel den Hoed Cancer Center
Rotterdam, The Netherlands
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F. Stephen Hodi, MD
Professor of Medicine
Harvard Medical School
Dana-Farber Cancer Institute
Boston, MA
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Jedd D. Wolchok, MD, PhD
Memorial Sloan-Kettering Cancer Center
Director, Immunotherapy Clinical Trials
Associate Attending Physician,
Melanoma-Sarcoma Oncology Service
Associate Director, Ludwig Center for
Cancer Immunotherapy
Associate Professor of Medicine,
Weill Medical College of Cornell University
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Peer Review Process of Conflicts of Interest
This educational activity has been independently peer-reviewed.
Disclosure of Unlabeled Uses
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the US Food and Drug Administration (FDA). For additional information about approved uses, including approved indications, contraindications, and warnings, please refer to the prescribing information for each product or consult the Physicians' Desk Reference.
The Oncology Learning Center (OLC) does not recommend the use of any agent outside of the FDA labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the OLC. Please refer to the official FDA prescribing information for each product for discussion of approved indicated, contraindications, and warnings.
Acknowledgement of Supporters
| Educational Grants |
Sincere appreciation is extended to the following companies for their generous support of this educational meeting: |
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