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Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2016-12-10

Total Pages: 135

ISBN-13: 030944232X

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.

Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2019-10-05

Total Pages: 89

ISBN-13: 0309490863

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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 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.

The Drug Development Paradigm in Oncology

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2018-02-12

Total Pages: 145

ISBN-13: 0309457971

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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.

Cancer Immunotherapy Principles and Practice

Author: Lisa H. Butterfield, PhD

Publisher: Springer Publishing Company

Published: 2017-06-28

Total Pages: 920

ISBN-13: 1617052736

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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

Immunotherapy in Translational Cancer Research

Author: Laurence J. N. Cooper

Publisher: John Wiley & Sons

Published: 2018-05-01

Total Pages: 306

ISBN-13: 1118123220

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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.

Immunotherapy of Hepatocellular Carcinoma

Author: Tim F. Greten

Publisher: Springer

Published: 2017-10-04

Total Pages: 167

ISBN-13: 3319649582

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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.

Addressing Treatment Resistance in the Development of Cancer Immune Modulator Therapeutics

Author: National Academies of Sciences Engineering and Medicine

Publisher:

Published: 2024-12-13

Total Pages: 0

ISBN-13: 9780309716260

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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.

Cancer Immunotherapy

Author: Tyler J. Curiel

Publisher: Springer Science & Business Media

Published: 2012-11-07

Total Pages: 486

ISBN-13: 1461447321

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This work will provide a historical perspective on tumor immunotherapy, discuss fundamental mechanisms of failed tumor rejection, look at passive strategies to boost anti-tumor immunity, as well as have an in-depth look at active strategies to boost anti-tumor immunity.

SITC’s Guide to Managing Immunotherapy Toxicity

Author: Marc S. Ernstoff, MD

Publisher: Springer Publishing Company

Published: 2019-03-15

Total Pages: 250

ISBN-13: 0826172156

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The Society for Immunotherapy of Cancer's handbook,SITC’s Guide to Managing Immunotherapy Toxicity, is a practical reference to managing side effects associated with FDA-approved cancer immunotherapy drugs. Separated into two parts, Part I contains chapter-based overviews of immune checkpoint inhibitors in the clinic, starting with anti-CTLA4 agents, anti-PD1/PD-L1 agents, and approved immunotherapeutic combinations. These chapters cover relevant mechanisms of action, indications, and toxicities seen while combating early, advanced, and metastatic stages in cancer patients. Part II is structured by common and uncommon toxicities that affect major organ sites throughout the body. It begins with a general summary of principles and management options followed by chapters focusing on specific toxicities such as rash and mucosal irritation, muscle and joint toxicity, diarrhea and colitis, pneumonitis, endocrine toxicities, neurological toxicities, cardiac toxicity, renal toxicity, hematologic toxicity, and ocular toxicities. Each chapter provides guidance on how to assess and treat the toxicity and how to support the patient through acute and chronic effects with detailed summary tables for quick reference. Part II concludes with chapters covering management of special patient populations, including patients with autoimmune disease and geriatric patients, treatment and management of fatigue, and a final chapter dedicated to cost effectiveness and the toll of financial toxicity on patients and caregivers. With chapters written by world-recognized leaders in the immuno-oncology field, this text provides thorough coverage of the toxicity and management of adverse effects for immune checkpoint inhibitors. It is an indispensable resource for clinical oncologists, emergency physicians, hospitalists and other medical practitioners in both the hospital and community clinic settings, especially as the use of immune checkpoint inhibitors becomes a fixture in oncology care. Key Features: Outlines strategies for treating high-risk patients facing an acute or chronic side effect to immunotherapy Provides numerous tables that condense and highlight pertinent information for quick reference Describes the various clinical presentations and toxic reactions caused by immunotherapy Purchase includes access to the eBook for use on most mobile devices or computer

Clinical Pharmacy Education, Practice and Research

Author: Dixon Thomas

Publisher: Elsevier

Published: 2018-11-23

Total Pages: 540

ISBN-13: 0128142774

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Clinical Pharmacy Education, Practice and Research offers readers a solid foundation in clinical pharmacy and related sciences through contributions by 83 leading experts in the field from 25 countries. This book stresses educational approaches that empower pharmacists with patient care and research competencies. The learning objectives and writing style of the book focus on clarifying the concepts comprehensively for a pharmacist, from regular patient counseling to pharmacogenomics practice. It covers all interesting topics a pharmacist should know. This book serves as a basis to standardize and coordinate learning to practice, explaining basics and using self-learning strategies through online resources or other advanced texts. With an educational approach, it guides pharmacy students and pharmacists to learn quickly and apply. Clinical Pharmacy Education, Practice and Research provides an essential foundation for pharmacy students and pharmacists globally. Covers the core information needed for pharmacy practice courses Includes multiple case studies and practical situations with 70% focused on practical clinical pharmacology knowledge Designed for educational settings, but also useful as a refresher for advanced students and researchers