Proceedings From the ASCO/College of American Pathologists Immune Checkpoint Inhibitor Predictive Biomarker Summit.

PURPOSE: Immune checkpoint inhibition (ICI) therapy represents one of the great advances in the field of oncology, highlighted by the Nobel Prize in 2018. Multiple predictive biomarkers for ICI benefit have been proposed. These include assessment of programmed death ligand-1 expression by immunohistochemistry, and determination of mutational genotype (microsatellite instability or mismatch repair deficiency or tumor mutational burden) as a reflection of neoantigen expression. However, deployment of these assays has been challenging for oncologists and pathologists alike. METHODS: To address these issues, ASCO and the College of American Pathologists convened a virtual Predictive Factor Summit from September 14 to 15, 2021. Representatives from the academic community, US Food and Drug Administration, Centers for Medicare and Medicaid Services, National Institutes of Health, health insurance organizations, pharmaceutical companies, in vitro diagnostics manufacturers, and patient advocate organizations presented state-of-the-art predictive factors for ICI, associated problems, and possible solutions. RESULTS: The Summit provided an overview of the challenges and opportunities for improvement in assay execution, interpretation, and clinical applications of programmed death ligand-1, microsatellite instability-high or mismatch repair deficient, and tumor mutational burden-high for ICI therapies, as well as issues related to regulation, reimbursement, and next-generation ICI biomarker development. CONCLUSION: The Summit concluded with a plan to generate a joint ASCO/College of American Pathologists strategy for consideration of future research in each of these areas to improve tumor biomarker tests for ICI therapy.

Medicaid Expansions: Probing Medicaid's Filling of the Cancer Genetic Testing and Screening Space.

Cancer is the third largest source of spending for Medicaid in the United States. A working group of the American Public Health Association Genomics Forum Policy Committee reviewed 133/149 pieces of literature addressing the impact of Medicaid expansion on cancer screening and genetic testing in underserved groups and the general population. Breast and colorectal cancer screening rates improved during very early Medicaid expansion but displayed mixed improvement thereafter. Breast cancer screening rates have remained steady for Latina Medicaid enrollees; colorectal cancer screening rates have improved for African Americans. Urban areas have benefited more than rural. State programs increasingly cover BRCA1/2 and Lynch syndrome genetic testing, though testing remains underutilized in racial and ethnic groups. While increased federal matching could incentivize more states to engage in Medicaid expansion, steps need to be taken to ensure that they have an adequate distribution of resources to increase screening and testing utilization.

Incorporating Patient Advocates in Oncology Clinical Development: Lessons Learned From a Novel Pilot Program.

The advent of patient-focused drug development (PFDD) has underscored the priority of engaging the "voice of the patient" in therapy development. Industry sponsors are working to enhance engagement of patients early, particularly within decision making for design and execution of clinical trials. This trend is especially significant within oncology, as industry leaders partner with patient advocacy organizations, individual patients, and clinicians to enhance patient-centricity. These partnerships often require a willingness to change attitudes, approaches, and processes to reshape traditional models of drug development. In 2016, Bayer Oncology launched a pilot program called the Patient Advocate Advisory Council (PAAC), to design and execute a program whereby patients join clinical development teams. The PAAC, composed of experienced patient advocates from the US and Europe, worked closely with company leaders to design and execute a pilot in an ongoing clinical development program. The PAAC and Bayer teams have identified important learnings from the first phase of the program, emphasizing earlier engagement of patient advisors, launching the enhanced training platform, and recruiting additional PAAC members to expand the initiative's reach across the cancer community. A critical success factor is having champions for patient engagement within the company to ensure that activities are streamlined and standardized as patient engagement becomes more common. This is particularly important given that patient engagement should be a long-term investment with sufficient and sustained resources. PAAC members and Bayer have committed to sharing learnings, to advance opportunities for successful patient engagement in drug development throughout the oncology therapeutic landscape.

XRAYS (eXamining Relevance of Articles to Young Survivors) Program Survey of Information Needs and Media Use by Young Breast Cancer Survivors and Young Women at High-Risk for Breast Cancer.

Women age 45 years or younger with breast cancer, or who are at high-risk for breast cancer due to previously having the disease or to genetic risk, have distinct health risks and needs from their older counterparts. Young women frequently seek health information through the Internet and mainstream media, but often find it does not address their particular concerns, that it is difficult to evaluate or interpret, or even misleading. To help women better understand media coverage about new research, Facing Our Risk of Cancer Empowered (FORCE) developed the CDC-funded XRAYS (eXamining Relevance of Articles to Young Survivors) program. To assure that the XRAYS program is responsive to the community's needs, FORCE launched a web-based survey to assess where young women seek information about breast cancer, and to learn their unmet information needs. A total of 1,178 eligible women responded to the survey. In general, the breast cancer survivors and high-risk women between ages 18-45 years who responded to this survey, are using multiple media sources to seek information about breast cancer risk, prevention, screening, and treatment. They place trust in several media sources and use them to inform their medical decisions. Only about one-third of respondents to this survey report discussing media sources with their health care providers. Current survey results indicate that, by providing credible information on the quality of evidence and reporting in media reports on cancer, XRAYS is addressing a key need for health information. Results suggest that it will be useful for XRAYS to offer reviews of articles on a broad range of topics that can inform decisions at each stage of risk assessment and treatment.