Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume I—conceptual challenges

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With the advent of immunotherapeutic agents, durable and dramatic responses have been observed in several hard-to-treat malignancies, outlining a roadmap to conquering cancer. Immune checkpoint inhibitors (ICPi) are a class of immunotherapeutic agents that attack the tumor cells by reinvigorating the suppressed immune system. However, the unbridled T-cell activity disrupts the immune homeostasis and induces a unique spectrum of side effects called immune-related adverse events (irAEs) in a significant proportion of patients. These irAEs are distinct from the side effects produced by traditional chemotherapeutic agents. Although majority of irAEs are manageable with corticosteroids and other immunosuppressive agents, life-threatening and fatal events have been reported. In the absence of predictive biomarkers to identify patients at risk for irAEs and standardized approach to detect, report, and treat irAEs, management of irAEs has been challenging to the patients, caregivers and the healthcare providers alike. With increasing use of ICPis for treatment of various cancers, the incidence of irAEs will undoubtedly increase. There is a compelling need to develop measures to effectively manage irAEs, both in the community settings and in cancer centers alike. To this end, in this paper, we propose several strategies, such as providing patient education, harmonizing irAE management guidelines, standardizing reporting of irAEs, optimizing the choice of immunosuppressive agents, conducting preclinical, clinical and translational studies to better understand irAEs, including high-risk patients, incorporating diagnostic tools to personalize irAE management using wireless technology and digital health, providing a platform to hear the missing patient’s voice, and sharing evolving data to improve the management of irAEs.

Section: Sharing Evolving Datamentioning

confidence: 99%

Strategies for improving the management of immune-related adverse events

Naing

Hajjar

Gulley

et al. 2020

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“…7 ► Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume I-conceptual challenges. 8 ► Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume II-practical challenges. 9 Technology primers ► Immune monitoring technology primer: immunosequencing.…”

Section: Overviewmentioning

confidence: 99%

SITC cancer immunotherapy resource document: a compass in the land of biomarker discovery

Hu‐Lieskovan

Bhaumik

Dhodapkar

et al. 2020

Since the publication of the Society for Immunotherapy of Cancer’s (SITC) original cancer immunotherapy biomarkers resource document, there have been remarkable breakthroughs in cancer immunotherapy, in particular the development and approval of immune checkpoint inhibitors, engineered cellular therapies, and tumor vaccines to unleash antitumor immune activity. The most notable feature of these breakthroughs is the achievement of durable clinical responses in some patients, enabling long-term survival. These durable responses have been noted in tumor types that were not previously considered immunotherapy-sensitive, suggesting that all patients with cancer may have the potential to benefit from immunotherapy. However, a persistent challenge in the field is the fact that only a minority of patients respond to immunotherapy, especially those therapies that rely on endogenous immune activation such as checkpoint inhibitors and vaccination due to the complex and heterogeneous immune escape mechanisms which can develop in each patient. Therefore, the development of robust biomarkers for each immunotherapy strategy, enabling rational patient selection and the design of precise combination therapies, is key for the continued success and improvement of immunotherapy. In this document, we summarize and update established biomarkers, guidelines, and regulatory considerations for clinical immune biomarker development, discuss well-known and novel technologies for biomarker discovery and validation, and provide tools and resources that can be used by the biomarker research community to facilitate the continued development of immuno-oncology and aid in the goal of durable responses in all patients.

“…The establishment of a better space for secondary biomarker data interrogations by making clinical trial data sets more accessible to the broader research community would require the implementation of a data standards workflow process that would allow data sharing to be undertaken in a responsible manner. At the same time, however, the implementation of such a process could present several additional complex challenges related either to the nature of the stakeholders involved in providing such data (eg, sponsors and funders, clinical trialists, and regulatory authorities as discussed in the companion Volume I to this manuscript 1 ), or to the quality and maintenance of the data committed to sharing via a central repository. Hence, in order to ensure that data sharing becomes meaningful, any prospective biomarker data repository should abide by a data standards workflow process.…”

Section: Workforce Challengesmentioning

confidence: 99%

“…The companion Volume I to this manuscript discusses the protection of patient privacy in greater detail. 1 …”

Section: Workforce Challengesmentioning

confidence: 99%

“…While the companion volume to this paper, ‘Society for Immunotherapy of Cancer clinical and biomarkers data-sharing resource document: Volume I—conceptual challenges’, provides an overview of the surrounding framework and proposed activities of stakeholders for responsible and successful data sharing, this practical challenges volume will examine and address the more procedural details of the current hurdles to data sharing. 1 Here, we dissect those hurdles down to basic approachable elements that must be addressed to encourage better data-sharing strategies and compliance. Additionally, we put forward timely recommendations and methodological guidelines that will also remain flexible enough for adaptation to both current and future landscapes of data sharing.…”

Section: Introduction: Practical Challenges In Data Sharing For Clinimentioning

confidence: 98%

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Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume II—practical challenges

Cesano

Cannarile

Gnjatic

et al. 2020

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The development of strongly predictive validated biomarkers is essential for the field of immuno-oncology (IO) to advance. The highly complex, multifactorial data sets required to develop these biomarkers necessitate effective, responsible data-sharing efforts in order to maximize the scientific knowledge and utility gained from their collection. While the sharing of clinical- and safety-related trial data has already been streamlined to a large extent, the sharing of biomarker-aimed clinical trial derived data and data sets has been met with a number of hurdles that have impaired the progression of biomarkers from hypothesis to clinical use. These hurdles include technical challenges associated with the infrastructure, technology, workforce, and sustainability required for clinical biomarker data sharing. To provide guidance and assist in the navigation of these challenges, the Society for Immunotherapy of Cancer (SITC) Biomarkers Committee convened to outline the challenges that researchers currently face, both at the conceptual level (Volume I) and at the technical level (Volume II). The committee also suggests possible solutions to these problems in the form of professional standards and harmonized requirements for data sharing, assisting in continued progress toward effective, clinically relevant biomarkers in the IO setting.