Bristol-Myers Squibb Independent Medical Education

Transcription

1 Bristol-Myers Squibb Independent Medical Education Request for Educational Support (RFE) Date 4/19/18 RFE Requestor Information RFE Code Name: Maria Deutsch, MS, PharmD Title: IME Specialist, Oncology RFE-18-ONC-102 Therapeutic Area Cancer immunotherapy Immune checkpoint inhibitors Solid and hematologic tumors Area of Interest Immune system function in cancer and the mechanism of action of immuno-modulatory agents The role of biomarkers in guiding cancer treatment Current and future role of biomarker testing in predicting response to immunotherapies in cancer Biology/foundational knowledge of tumor mutational burden and other novel biomarkers Educational Design Bristol-Myers Squibb is interested in supporting a comprehensive educational initiative that includes the following: Innovative live satellite symposium at the College of American Pathologists (CAP) 2018 Annual Meeting (October 20-24) Live simultaneous video webcast during the meeting Web-based enduring activity leveraging the medical content from the live meeting Intended Audience (may include, but not limited to) Budget/Budget Range Knowledge, competency, and performance-based objective outcome measures according to Moore s Level 4 are required; Level 5 outcomes are highly preferred. Pathologists, oncologists, hematologists, cytotechnologists, researchers, and other relevant healthcare and laboratory professionals interested in immuno-oncology, precision medicine, and/or biomarker research. The anticipated program is expected to be achieved with a BMS budget of no more than $200,000.

2 Single and multi-supported initiatives will be considered. Accreditation Geographic Coverage Deadline for Submission (Date and Time) ACCME, ANCC, ACPE, and others as appropriate United States May 29, 2018 by 5pm EST Background: Medical oncologists, oncology pathologists, clinical/biomedical researchers, and other healthcare professionals interested in precision medicine and/or biomarker research contribute to cancer diagnosis, prognosis and treatment through knowledge gained by the laboratory application of the biologic, chemical and physical sciences. The future of cancer care incorporates advanced technology with many forms of testing, including genomic sequencing, molecular diagnostics, liquid biopsies, cytology specimens, and image analytics. This presents an increasingly complex framework within which practicing pathologists, in order to diagnose and recommend the best treatment strategies, must be knowledgeable of emerging clinical research methodologies and results utilizing evolving technology. The advances in molecular pathology as part of personalized medicine has brought about new challenges in the continuum of care for cancer patients. Immuno-oncology (I-O) and associated immuno-therapies are rapidly developing areas of oncology. Characterizing the immune profile of a tumor is essential when personalizing treatment. Therefore, there is increasing pressure by the oncology community to quantify and validate predictive and diagnostic biomarkers and to understand their role in therapeutic approaches to cancer treatment. Healthcare and laboratory professionals should thus be aware of the targeted biomarker testing currently available, the clinical utility of biomarker testing in patients, and the mechanisms and timeframe essential to ordering biomarker testing and interpreting test results. For example, Tumor Mutational Burden (TMB), an emerging biomarker, is measured using next generation sequencing (NGS) that has demonstrated potential for predicting response to I-O agents. Tumor and immune biomarkers are currently being evaluated to better predict response to I-O therapy with research focusing on specific tumor antigens, inflamed tumor phenotypes, tumor immune suppression, and host environment. The ultimate goal is to leverage biomarkers and diagnostic tools with the aim of potentially increasing survival for more patients. Due to the large amount of clinical data available on the role of biomarkers in guiding cancer immunotherapy treatment for various tumor types, interrogation and integration of the data in a live setting for a broad audience at a key professional meeting is warranted.

3 Since many healthcare professionals working in a multidisciplinary oncology team do not have the opportunity to attend live meetings, it is necessary and important to make the activities correlated with these meetings available through internet/computer-based modalities as well. Educational Needs: This activity will ensure timely and effective communication of the latest science, clinical trial data, and biomarker data for current and emerging immunotherapies. Key clinical data, barriers to care and practice gaps will be addressed through the educational program on various treatment options. At the conclusion of the activity, participants should be able to: Analyze new clinical trial data on the utility of biomarkers to guide treatment with cancer immunotherapies across tumor types Evaluate the role of biomarkers in patient selection for checkpoint inhibitors (ie, PD1/PD-L1; LAG-3) across different tumor types and lines of therapy Discuss biomarker prevalence across different tumor types/histology(s) and assess the clinical utility of selected biomarkers to guide treatment selection in patients based on clinical trial data Recognize current investigational efforts to identify other potential biomarkers of response to cancer immunotherapies (tumor mutational burden, microsatellite instability, tumor infiltrating lymphocytes, composite or combinations of biomarkers, etc.) and consider how these may be applied in future clinical practice Review additional efforts evaluating cytology samples for biomarker profiling (ex: blood/serum-based markers, circulating tumor cells, etc.) Understand the utility of NGS and comprehensive gene panels in identifying potential biomarkers of novel immuno-oncology (I-O) therapeutics and/or predictors of response to I-O, including tumor mutational burden Recognize the potential utility of NGS in characterizing the tumor microenvironment Understand the advantages and limitations of NGS technology and comprehensive gene panels used in I-O research today Specific Area of Interest: BMS is interested in funding an innovative, interactive, educational activity that addresses the above educational needs. References: 1. Bauml JM, Cohen RB, Aggarwal C. Immunotherapy for head and neck cancer: latest developments and clinical potential. Ther Adv Med Oncol May;8(3): Chalmers ZR, Connelly CF, Fabrizio D, et al. Analysis of 100,000 human cancer genomes reveals the landscape of tumor mutational burden. Genome Medicine 2017.

4 3. Gatalica Z, Vanderwalde AM, Rose I, et al. Distribution of PD-L1 expression in diverse cancer types: Experience with over 10,000 cases [ASCO abstract 11548]. J Clin Oncol. 2016;34 (suppl). 4. George TJ, Frampton GM, Sun J, et al. Tumor mutational burden as a potential biomarker for PD1/PD-L1 therapy in colorectal cancer [ASCO abstract 3587]. J Clin Oncol. 2016;34(suppl). 5. Hellmann MD, Ciuleanu TE, Pluzanski A, et al. Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden. NEJM. April 16, DOI: /NEJMoa Johnson DB, Frampton GM, Rioth MJ et al. Targeted Next Generation Sequencing Identifies Markers of Response to PD-1 Blockade. Cancer Immunology Research Kerr KM1, Nicolson MC. Non-Small Cell Lung Cancer, PD-L1, and the Pathologist. Arch Pathol Lab Med Mar; 140(3): doi: /arpa SA. 8. Patel SP, Kurzrock R. PD-L1 expression as a predictive biomarker in cancer immunotherapy. Mol Cancer Ther Apr; 14 (4): Rizvi NA, Hellmann MD, Snyder A, et al. Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science Apr 3;348(6230): Spencer KR, Wang J, Silk AW, Ganesan S, Kaufman HL, Mehnert JM. Biomarkers for immunotherapy: current developments and challenges. Am Soc Clin Oncol Educ Book. 2016;35:e Taube JM, Klein A, Brahmer JR, et al. Association of PD-1, PD-1 ligands, and other features of the tumor immune microenvironment with response to anti-pd-1 therapy. Clin Cancer Res Oct 1;20 (19): Ung C, Kockx MM. Challenges & perspectives of immunotherapy biomarkers & the HistoOncoImmune methodology. Expert Rev Precis Med Drug Dev Feb 9;1(1): Accessed October 6, Thakur MK1, Gadgeel SM Predictive and Prognostic Biomarkers in Non-Small Cell Lung Cancer.Semin Respir Crit Care Med Oct; 37(5): Epub 2016 Oct Zehir A, Benayed R, Shah RH, et a. Mutational landscape of metastatic cancer revealed from prospective clinical sequencing of 10,000 patients. Nature Medicine Ma W, Gilligan BM, Yuan J, et al. Current Status and Perspectives in Translational Biomarker Research for PD-1/PD-L1 Immune Checkpoint Blockade Therapy. J of Hematol & Oncol. 2016;(9) Sharma P, Allison JP. The future of immune checkpoint therapy. Science. 2015;348(6230): Yuan J, Hedge PS, Clynes R, et al. Novel technologies and emerging biomarkers for personalized cancer immunotherapy. J ImmunoTher Cancer Jan 19;4:3. The content and/or the format of the CME/CE activity and its related materials must be designed in such a way that it addresses the educational needs of health care professionals and, if appropriate, tools/aids that can help health care practitioners communicate with or better manage their patients. Presentations and content must give a scientifically sound, fair and balanced overview of new and emerging therapeutic options currently available or in development to manage or prevent this disease. Note: The accredited provider and, if applicable, the medical education provider (MEP) or other third party executing the activities are expected to comply with current ethical codes and regulations. They must have a conflict-of-interest policy in place to identify and resolve all conflicts of interest from all contributors and staff developing the content of the activity prior to delivery of the program, and must

5 have a separate company providing/accrediting independent medical education if they are also performing promotional activities. If your organization wishes to submit an educational grant request, please use the online application available on the Bristol-Myers Squibb Independent Medical Education website: Grant Proposals should include, but not be limited to, the following information: Executive Summary: The Executive Summary should consist of 1-2 pages and highlight the key areas as described below. Needs Assessment/Gaps/Barriers: Needs assessment should be referenced and demonstrate an understanding of the specific gaps and barriers of the target audiences. The needs assessment must be independently developed and validated by the educational provider. Target Audience and Audience Generation: Target audience for educational program must be identified within the proposal. In addition, please describe methods for reaching target audience(s) and any unique recruitment methods that will be utilized. The anticipated or estimated participant reach should also be included, with a breakdown for each modality included in the proposal, as applicable (e.g., number of participants for the live activity, the live webcast, and enduring activity). Learning Objectives: The learning objectives must be written in terms of what the learner will achieve as a result of attending. The objectives must be clearly defined, measurable, attainable and address the identified gaps and barriers. Educational Design and Methods: Describe the approach used to address knowledge, competence, and performance gaps that underlie identified healthcare gaps. The proposal should include strategies that ensure reinforcement of learning through use of multiple educational interventions and include practice resources and tools, as applicable. Communication and Publication Plan: Provide a description of how the provider will communicate the progress and outcomes of the educational program to the supporter It is highly recommended to describe how the results of the activity will be presented, published, or disseminated. Innovation: Describe how this project is innovative and engages the learners to improve knowledge, competence and/or performance. Further describe how this project might build on existing work, pilot projects or ongoing projects developed either by your institution or other institutions related to this topic. Program Evaluation and Outcomes Reporting: Description of the approach to evaluate the reach and quality of the educational program. Describe methods used for determining the impact of the educational program on closing identified healthcare gaps. o Please refer to Guidance for Outcomes Report (on the BMS grants website) for a detailed explanation of preferred outcomes reporting methods and timelines. o Remember that knowledge, performance and competency based outcome measures according to Moore s Levels 4 & 5 are required. Level 6 outcomes are highly favored and recommended when possible. Budget: Detailed budget with rationale of expenses, including breakdown of costs, content cost per activity, out-of-pocket cost per activity, and management cost per activity.