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Suggested Citation:"Appendix A: Statement of Task." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
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Page 61
Suggested Citation:"Appendix A: Statement of Task." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
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Page 62

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Appendix A Statement of Task An ad hoc committee will plan and host a 1.5-day public workshop that will examine the opportunities to improve the clinical development of immune checkpoint inhibitors for cancer therapy, including in the context of site-agnostic indications. The workshop will feature invited presenta- tions and panel discussions on topics that may include the challenges and opportunities for improving: • The development, validation, and standardization of biomarkers for patient selection. • The assessment of safety and efficacy/clinical benefit in clinical trials. • Innovations in clinical development programs for combination treatment strategies, such as approaches for prioritizing potential combinations (including multimodal therapy), the role of preclinical modeling to identify promising combinations, and mechanisms for facilitating access to the best drug candidates for combination trials. • Evidence requirements and decision making in drug development and regulatory evaluation for site-agnostic indications. • Collaboration and information exchange among clinicians, research- ers, and the pharmaceutical and diagnostic industries, including precompetitive collaboration, especially for the development of biomarkers predictive of immune-related toxicities and treatment response. 61 PREPUBLICATION COPY—Uncorrected Proofs

62 CANCER THERAPIES WITH IMMUNE CHECKPOINT INHIBITORS The committee will develop the agenda for the workshop sessions, select and invite speakers and discussants, and moderate the discussions. A proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines. PREPUBLICATION COPY—Uncorrected Proofs

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In recent years, significant progress has been made in the clinical development and use of various types of cancer immunotherapy, all of which rely on the immune system to fight cancer. The majority of new cancer drug applications submitted to the Food and Drug Administration (FDA) are for immunotherapies or combinations involving immunotherapies. One type of immunotherapy is an immune checkpoint inhibitor. Cells in the human body have proteins that regulate the immune system response to foreign invaders (e.g., cancer cells, microorganisms). However, cancer cells can coopt these “checkpoint” proteins and thwart the immune system’s ability to recognize and attack cancer cells. To help promote an immune response to cancer, researchers have developed immune checkpoint inhibitors that enable T-cells to recognize cancer cells as foreign and to prevent deactivation of an immune system response.

To examine the challenges and opportunities to develop combination cancer therapies that include immune checkpoint inhibitors, the National Cancer Policy Forum held a workshop on July 16–17, 2018, in Washington, DC. This workshop convened stakeholders with a broad range of expertise, including cancer researchers, clinicians, patient advocates, and representatives from industry, academia, and government. This publication summarizes the presentations and discussions from the workshop.

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