Policy Issues In The Clinical Development And Use Of Immunotherapy For Cancer Treatment

Immunotherapy is a form of cancer therapy that harnesses the body's immune system to destroy cancer cells. In recent years, immunotherapies have been developed for several cancers, including advanced melanoma, lung cancer, and kidney cancer. In some patients with metastatic cancers who have not responded well to other treatments, immunotherapy treatment has resulted in complete and durable responses. Given these promising findings, it is hoped that continued immunotherapy research and development will produce better cancer treatments that improve patient outcomes. With this promise, however, there is also recognition that the clinical and biological landscape for immunotherapies is novel and not yet well understood. For example, adverse events with immunotherapy treatment are quite different from those experienced with other types of cancer therapy. Similarly, immunotherapy dosing, therapeutic responses, and response time lines are also markedly different from other cancer therapies. To examine these challenges and explore strategies to overcome them, the National Academies of Sciences, Engineering, and Medicine held a workshop in February and March of 2016. This report summarizes the presentations and discussions from the workshop.

Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.

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 16â€"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.

A guide to state-of-the-art cancer immunotherapy in translational cancer research A volume in the Translational Oncology series, Immunotherapy in Translational Cancer Research explores the recent developments in the role that immunotherapy plays in the treatment of a wide range of cancers. The editors present key concepts, illustrative examples, and suggest alternative strategies in order to achieve individualized targeted therapy. Comprehensive in scope, Immunotherapy in Translational Cancer Research reviews the relevant history, current state, and the future of burgeoning cancer-fighting therapies. The book also includes critical information on drug development, clinical trials, and governmental resources and regulatory issues. Each chapter is created to feature: development of the immunotherapy; challenges that have been overcome in order to scale up and undertake clinical trials; and clinical experience and application of research. This authoritative volume is edited by a team of noted experts from MD Anderson Cancer Center, the world’s foremost cancer research and care center and: Offers a comprehensive presentation of state-of-the-art cancer immunotherapy research that accelerates the pace of clinical cancer care Filled with the concepts, examples, and approaches for developing individualized therapy Explores the breath of treatments that reflect the complexity of the immune system itself Includes contributions from a panel international experts in the field of immunotherapy Designed for physicians, medical students, scientists, pharmaceutical executives, public health and public policy government leaders and community oncologists, this essential resource offers a guide to the bidirectional interaction between laboratory and clinic immunotherapy cancer research.

The use of immune modulator therapeutics, a type of immunotherapy enhancing the body immune system response to cancer, was perceived as the beginning of a new era in cancer care. While still important and frequently used, some of these therapeutics produce uneven response rates, disease resistance, and serious side effects. The National Academies National Cancer Policy Forum, in collaboration with the Forum on Drug Discovery, Development, and Translation, hosted a public workshop to discuss challenges related to immunotherapy treatment resistance, as well as potential policy opportunities to improve the development of immunotherapies for cancer treatment.

Therapeutic cancer vaccines represent a type of active cancer immunotherapy. Clinicians, scientists, and researchers working on cancer treatment require evidence-based and up-to-date resources relating to therapeutic cancer vaccines. Vaccines for Cancer Immunotherapy provides a reference for cancer treatment for clinicians and presents a well-organized resource for determining high-potential research areas. The book considers that this promising modality can be made more feasible as a treatment for cancer. Chapters cover cancer immunology, general approaches to cancer immunotherapy, vaccines, tumor antigens, the strategy of allogeneic and autologous cancer vaccines, personalized vaccines, whole-tumor antigen vaccines, protein and peptide vaccines, dendritic cell vaccines, genetic vaccines, candidate cancers for vaccination, obstacles to developing therapeutic cancer vaccines, combination therapy, future perspectives and concluding remarks on therapeutic cancer vaccines. Introduces the feasible immunotherapeutic vaccines for patients with different types of cancer Presents the status of past and current vaccines for cancer treatment Considers advantages and disadvantages of different therapeutic cancer vaccines Looks at the combination of vaccines and other modalities, including immunotherapeutic and conventional methods Analyzes obstacles to development of therapeutic cancer vaccines Gives a view on future perspectives in the application of therapeutic cancer vaccines

Cancer Immunotherapy Principles and Practice, from the Society of Immunotherapy of Cancer (SITC), is the authoritative reference on cancer immunobiology and the immunotherapy treatments that harness the immune system to combat malignant disease. Featuring five sections and over 50 chapters covering the Basic Principles of Tumor Immunology, Cancer Immunotherapy Targets and Classes, Immune Function in Cancer Patients, Disease Specific Treatments and Outcomes, and Regulatory Aspects of Cancer Immunotherapy, this book covers all major topics that have shaped the development of immunotherapy and propelled it to its current place at the forefront of cancer treatment innovation. This volume is a comprehensive resource for oncologists and fellows, immunologists, cancer researchers, and related practitioners seeking understanding of the basic science and clinical applications of cancer immunotherapy. As well as presenting the evidence for immune-based cancer treatment, it positions immunotherapy in the context of other available cancer treatments and provides data on response rates, risks, and toxicities across a variety of diseases. Filled with detailed tables, and instructive illustrations, as well as key points for quick reference, Cancer Immunotherapy Principles and Practice simplifies a challenging and dynamic subject. Key Features: Clearly summarizes the basic principles and research supporting cancer immunotherapy clinical translation Contains expert guidance and treatment strategies for all immunotherapy classes and agents, including cell-based therapies, monoclonal antibodies, cytokine therapies, checkpoint inhibitors, oncolytic viruses, adjuvant approaches, and treatment combinations Includes expert perspectives from leading authorities in the field Provides information on all FDA-approved immunotherapies, including clinical management and outcome data Discusses clinical aspects of immunotherapy for individual cancer types, including melanoma and other skin cancers, lung cancers, gynecologic cancers, gastrointestinal cancers, hematologic cancers, genitourinary cancers, head and neck cancers, sarcomas, brain and other CNS cancers, breast cancer, and pediatric malignancies. Explains regulatory aspects behind the development and approval of immunotherapy drugs Includes Online Access to the Digital Book

In this book we provide insights into liver – cancer and immunology. Experts in the field provide an overview over fundamental immunological questions in liver cancer and tumorimmunology, which form the base for immune based approaches in HCC, which gain increasing interest in the community due to first promising results obtained in early clinical trials. Hepatocellular carcinoma (HCC) is the third most common cause of cancer related death in the United States. Treatment options are limited. Viral hepatitis is one of the major risk factors for HCC, which represents a typical “inflammation-induced” cancer. Immune-based treatment approaches have revolutionized oncology in recent years. Various treatment strategies have received FDA approval including dendritic cell vaccination, for prostate cancer as well as immune checkpoint inhibition targeting the CTLA4 or the PD1/PDL1 axis in melanoma, lung, and kidney cancer. Additionally, cell based therapies (adoptive T cell therapy, CAR T cells and TCR transduced T cells) have demonstrated significant efficacy in patients with B cell malignancies and melanoma. Immune checkpoint inhibitors in particular have generated enormous excitement across the entire field of oncology, providing a significant benefit to a minority of patients.