Ten years ago, the field of immuno-oncology (IO) was largely under the radar. Since then, pharmaceutical companies, academic research centers, the National Institutes of Health and other organizations have been driving IO research and development at a rapid-fire pace. Today, cancer patients are well educated on the status of various IO therapies and are asking their physicians to consider using them to treat their cancer.
The challenge? Pathologists and laboratory professionals need to learn specialized information to keep up with the dizzying pace of innovation in IO to determine the best treatments for their patients.
Successes in Innovation
“The biggest successes in IO have been in checkpoint inhibitors. CTLA-4 and PD-1 are the most successful, approved checkpoint inhibitors that are being targeted,” says Robert Anders, MD, PhD, Chair of ASCP’s IO Work Group. Dr. Anders is Associate Professor of Pathology and Co-Director of the Tumor Microenvironment Lab at the Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University, who has been working with checkpoint inhibitors for over a decade
“Another rapidly unfolding innovation is the combination of IO therapies with other, non-IO therapies, such as chemotherapy or targeted therapy, in the hopes they will synergize or work better together than singly,” he says.
Checkpoint inhibitors are a major area of focus in IO for pathologists. In order for patients to receive these drugs, they have to have their tissue tested. Testing comes in two forms. One is an IHC stain which tests for the presence of the PD-L1 protein.
“For a number of cancers—bladder, lung, and gastric—the patient’s tumor needs to be stained for PD-L1. If it’s positive, the patient may be eligible for the treatment. It’s the pathologist who makes that determination,” Dr. Anders says.
The other form is molecular IO testing. The oncologist needs to know the molecular status of a patient’s tumor to determine which genes are mutated in the cancer and what is the mismatch repair status of a tumor. These tests are conducted by laboratory professionals and interpreted by pathologists.
CAR T-Cell Therapy
Another IO innovation is CAR T-cell therapy. These are patient-derived T-cells that are engineered in the laboratory to specifically attack a patient’s cancer if it expresses a certain protein. The T0-cells are expanded to make more of them, and are then infused into the patient. Cell therapy laboratories are often staffed by lab professionals and supervised by pathologists. CAR-T therapies have been most successful in hematopoietic tumors, such as lymphomas.
Yet another therapy is tumor vaccines. Part of the success of checkpoint inhibitors has been in tumors that are called “hot,” or tumors that are inflamed. The goal of vaccines is to convert cold tumors into hot tumors so that they might benefit from checkpoint inhibitors.
Specialized Education Bridges Knowledge Gap
In response to the IO knowledge gap facing pathologists and laboratory professionals, ASCP has assembled a team of experts to establish a comprehensive educational strategy to guide the development of specialized IO education. This education will enhance the knowledge and skills that pathologists and laboratory professionals need to meet the challenge of new diagnostics and therapy.
“We equate knowledge gaps with lesser patient outcomes,” said Harvey Rinder, MD, FASCP, Chair of ASCP’s Commission for Continuing Professional Development (CCPD). “When pathologists and laboratory professionals are completely familiar with IO diagnostics, we help to raise patients to the highest level of care. That is the driving force behind our IO educational initiatives.”
The IO Work Group, which the CCPD established, has developed the IO Education Strategy, based on the results of a needs assessment. Late last year, ASCP launched the first of 10 online educational modules that focus on hot topics in IO. In early 2018, the Society conducted a practice survey to identify existing practice patterns and educational gaps in its membership; results will help inform future education in IO.
Additionally, four quality improvement projects are under way, and ASCP has conducted an “IO ChangeMakers” series to empower pathologists and laboratory professionals to help shape their institutions’ policies, procedures and protocols for patient care around IO.
As IO research evolves, ASCP’s IO Work Group will continue to oversee the design and production of education materials in a variety of ways, through enduring materials, live webcasts, the website and live meetings. The collective expertise of the work group members, combined with the education developed by ASCP as a part of its IO strategy, ensures that ASCP members stay ahead of the curve in this rapidly evolving landscape.
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