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Immunotherapy as a field has generated novel immune-based strategies and revolutionized treatment options for malignant and nonmalignant hematologic diseases. The ASH Task Force on Immunotherapies has dedicated its recent efforts on improved access to clinical trials, fostering scientific exchange in the field of immunotherapy as it relates to hematology, and establishing strategic collaborations aimed at developing resources for management of adverse events resulting from the use of immunotherapies. One important project emerging from the task force that continued to gain ground in 2020 is the Summit on Immunotherapies for Hematologic Diseases, which is slated for early 2022.

The summit will focus on identifying and overcoming mechanisms of resistance to immunotherapies, improving the safety of these therapies, the application of immunotherapies to nonmalignant hematologic diseases, and enhancing manufacturing technologies to improve these therapies. A highly interactive program, the summit will feature didactic lectures, panel discussions, rapid-fire poster talks, and abstract presentations. Dr. Catherine Bollard, a member of the Task Force on Immunotherapies and the Summit on Immunotherapies Steering Committee, remarked about the direct relationship between the strength and rapid growth of immunotherapy and the future of the summit. “The future for the summit is strong,” she said, “as we focus to build and expand the program to ensure there is engagement by all stakeholders including those from academia, regulatory and industry.” This speaks to one of the chief goals of the summit: facilitating conversations and, hopefully, collaboration among scientists in different fields who might not normally interact.

COVID-19 has impacted seemingly every corner of medicine, and immunotherapies was no exception. And while the task force maintains its focus on immune-based therapies for patients with blood disorders, the connection has been inevitable. “With the development of cell therapies such as mesenchymal stromal cells, regulatory T cells, and antigen-specific T cells to control inflammatory disorders and infectious diseases (especially after bone marrow transplantation) there is an obvious link to extend the focus of this committee to COVID-19,” said Dr. Bollard. She noted that there are some cell-based therapies that are being utilized in current and forthcoming clinical trials for the treatment of SARS-CoV2 infection and/or COVID-19, as well as for the treatment of COVID-19–associated inflammatory sequelae such as multisystem inflammatory syndrome in children. The steering committee will be highly engaged in evaluating the impact of such therapies as the results of the clinical studies become available.

Another central strategic initiative is the ASH Workshop on Developing Biomarkers for CAR T Cells and BiTES® Toxicity and Efficacy. This interactive, invite-only one-day workshop was held virtually in October 2020 and concentrated efforts on the identification of biomarkers on toxicity and efficacy for chimeric antigen receptor T-cell (CAR-T) and other commercially approved immune effector cell (IEC) –mediated therapies. Roughly 50 investigators, representing academia, industry, regulatory bodies, and the National Institutes of Health (NIH) were convened in order to reach a consensus on which samples to collect (including timing) and what assays to use to identify novel biomarkers, and to develop plans for a national effort that would match a sample biobank and digital biobank with Cellular Immunotherapy Data Resource (CIDR) data.

Dr. Miguel Perales is one of the event’s co-organizers, along with Drs. Sophie Paczesny, Marcelo Pasquini, and Steven Pavletic. He noted that while CAR-T and T-cell engagers represent a paradigm shift in the treatment of patients with certain advanced hematologic malignancies, and new U.S. Food and Drug Association (FDA) approvals are expected in the coming months, they are also associated with unique toxicities such as cytokine release syndrome (CRS) and IEC-associated neurotoxicity syndrome (ICANS). “Most clinical centers voluntarily report data on commercial CAR-Ts to the Center for International Blood and Marrow Transplant Research (CIBMTR) CIDR,” he said. “However, no similar systematic effort exists when it comes to collecting samples from patients that could be used to identify biomarkers of safety and/or efficacy.” The organizers believe that addressing this unmet need can only be achieved through close collaboration and partnership from a broad collection of stakeholders, including industry partners, the FDA, NIH, CIBMTR, and ongoing support and leadership from ASH. “To really accelerate discoveries in the field and improve patient outcomes, we need to align all key stakeholders and develop a multicenter effort to build a sample biobank and digital biobank,” said Dr. Perales.

The workshop’s co-organizers are pleased that through this workshop, several action items were developed, and a resulting commentary will soon be submitted for publication in Blood Advances, outlining a proposed roadmap. They also wish to note that the event was truly a team effort in every way, and they express their gratitude to ASH staff members Charles Clayton, Judy Keen, Alice Kuaban, and Gabriella Ryan.

To learn more the programs and activities supporting this research priority, visit www.hematology.org/research/precision-medicine-initiative/improving-use-of-immunotherapies or email ashprecisionmedicine@hematology.org.

 

Be on the lookout for a new Blood review series covering the conceptual, laboratory, and clinical progress in applying novel immunotherapies to nonmalignant hematologic diseases, and the hematologic complications of novel immunotherapies. The series is edited by Drs. Cynthia E. Dunbar and Rodrigo Calado.

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