Industry Role in Cancer Research Innovation: 2022 Advancing the Science of Cancer in Latinos

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This is part of the “Advancing the Science of Cancer in Latinos: 2022 Conference Proceedings,” which summarizes findings and discussions of the 2022 Advancing the Science of Cancer in Latinos Conference on Feb. 23-25, 2022, in San Antonio, Texas.

Transformative Strategies for Integration of Health Equity Principles in Science and Access in the US

Dr. Edith A. Perez is the Serene M. and Frances C. Durling Professor of Medicine at the Mayo Clinic College of Medicine and the Chief Medical Officer at Bolt Biotherapeutics. Her presentation outlined strategies for health equity as exemplified by the National Academies of Sciences, Engineering, and Medicine (NASEM) Committee for Inclusion in Research, and the Health Equity Committee at Stand Up To Cancer (SU2C).

The NASEM initiative, which was requested by congress, focuses on improving the representation of women and underrepresented minorities in clinical trials and research. This work aims to identify policies and programs aimed at increasing inclusion, analyze the economic benefits of inclusion, highlight new programs designed to have the most positive impact on underrepresentation, and identify factors that best predict which programs and interventions are replicable and scalable.

SU2C’s Health Equity Committee began in 2018 and is committed to lowering the barriers of access to new treatments for all cancer patients. The committee seeks to change the health disparities landscape by supporting the inclusion of underrepresented populations into clinical trials, supporting clinical trials and research studies that include these populations, and influencing other funders to take similar, tangible steps to improve health equity. In pursuit of these goals, the committee developed criteria for proposals within the context of SU2C, including three critical components: an indication of whether the research will address the populations expected to benefit from widespread use of newly developed treatments; patient recruitment and retention plans for including historically underrepresented racial and ethnic populations; and a letter of support from the lead institution’s Chief Diversity Officer, or an equivalent position.

Dr. Perez closed by emphasizing the feasibility of making a significant and meaningful impact. It is an achievable and noble goal to ensure all communities have equal access to new, more effective screening, diagnosis, and treatments. In this way, cancer risk can be decreased, and all persons diagnosed with cancer may become long-term survivors.

Advancing Precision Medicine Through Comprehensive Molecular Profiling

Dr. Yashira Negrón Abril is Medical Science Liaison at Caris Life Sciences. She began by discussing the transition in health care over recent years from the “one-size-fits-all” approach of traditional medicine, to precision medicine enabled by comprehensive molecular profiling. This profiling allows physicians to identify patients at high risk, select the most appropriate treatment options, and match patients to clinical trials.

Caris Life Sciences is a molecular and diagnostic company that assesses DNA, RNA, and proteins for almost all cancer types to reveal a molecular blueprint that helps physicians and cancer patients make more precise and personalized treatment decisions. Over the past 10 years, Caris has gathered longitudinal clinical outcome data for over 275,000 patients, and more than 356,000 patients were tested in 2021 alone.

In order to build on this wealth of data, the Caris Precision Oncology Alliance (POA) was created, enabling physicians and researchers to optimize clinical care for cancer patients through scientific collaboration. POA members include over 59 leading cancer centers and universities from across the US, Europe, and Asia.

Dr. Negrón Abril closed by discussing the POA’s Healthcare Disparities Council, which was recently established to guide and drive high impact research studies focused on minority populations. To expand precision medicine’s reach, Dr. Negrón Abril stressed, equal access to comprehensive molecular profiling must be ensured, as well as the diversity of patient cohorts in both biomedical research and clinical trials. All stakeholders must continue working together to address the challenges of disparity in cancer treatment, ultimately achieving health equity across all populations.

How BMS is Addressing the Need for Greater Diversity in Clinical Trials

Lorena Kuri is Head of Diversity Strategy for Research and Development at Bristol-Myers Squibb (BMS). She began by discussing the need for diversity in clinical trials. In the US, four out of ten people are non-White, but only one out of ten clinical trial participants are non-White. Bristol-Myers Squibb is addressing this inequity through the Diversity in Clinical Trials Program.

Through the Diversity in Clinical Trials Program, BMS is committed to doing its part to help ensure patients have a fair and just opportunity to achieve optimal health outcomes. To achieve this goal, the program seeks to improve recruitment of a diverse participant population, with the goal that clinical trials become more reflective of real-world demographics. This program is process-driven, with permanent change as the ultimate goal, and it is empowered by diverse and inclusive talent. The program aims at having 25% of the US sites participating in new BMS clinical trials located in racially & ethnically diverse areas.

Dr. Kuri closed by outlining the Diversity in Clinical Trials Program’s focuses for the future: ensuring that processes are aligned with external commitments when selecting US sites and investigators; reducing practical obstacles to clinical trial participation; strictly adhering to FDA guidelines; tracking performance and ensuring commitments are maintained; incorporating community groups, partnerships, and external thought partners; and committing to internal and external diversity training. These goals will propel BMS on its path toward a more inclusive and equitable clinical trials program.

Increasing Access to Cancer Screening: Working with Latinx Communities in Texas

Dr. Michael del Aguila is Senior Director & Head of Population Health Sciences at GRAIL, a healthcare company focused on saving lives and improving health by pioneering new technologies for early cancer detection. Dr. del Aguila began by emphasizing the importance of early detection for survival, explaining that cancer patients show an 89% 5-year survival rate when diagnosed early, compared to 21% when diagnosed after metastasis. Furthermore, although the United States Preventive Services Task Force (USPSTF) has recommended screening for five cancers, 68% of cancer deaths are due to cancers without screening recommendations. Early detection therefore represents an important area in which GRAIL may make impactful change.

Because tumors shed nucleic acids carrying cancer-specific information into the blood and other bodily fluids, GRAIL developed a proprietary methylation-based technology for cancer detection. Selected for development based on the results of the first sub-study of the Circulating Cell-free Genome Atlas study (CCGA), GRAIL has since refined and commercially launched this technology as an investigational, multi-cancer, early detection Test called Galleri. The test was launched in June of 2021, and has a 44% positive predictive value, 0.5% false positive rate, and an 89% rate of cancer signal origin predicted correctly, with more than 50 cancer types detected.

Dr. del Aguila ended his talk by discussing the Reflection study from the Population Health Sciences program at GRAIL. This study is designed to distribute Galleri to 35,000 patients, with effort to achieve broad geographic, racial/ethnic, and socio-economic diversity. The Galleri test and the Reflection study represent a shift in approach for cancer screening: instead of screening for an individual cancer, individuals are being screened for multiple cancers. This shift could have a far-reaching impact on the cancer survival landscape.

Increasing Diversity in Clinical Research

Dr. Veronica Sandoval is a Principal in the Patient Inclusion and Health Equity team in the Chief Diversity Office at Genentech. Genentech’s mission is to deliver scientific innovations that drive outcomes for people, patients, businesses, and communities; and the company is taking bold action to champion diversity, equity, and inclusion. One of Genentech’s main pillars is advancing inclusive research and health equity, meaning that by 2025, all molecule teams will include population-specific assessments and inclusive action plans.

The Latino community makes up approximately 17% of the US population, but only 1-8% of clinical trial participants. Furthermore, 90% of the genomic material available to scientists is of European ancestry. To address this inequity, Genentech launched the Advancing Inclusive Research Site Alliance, a pilot partnership with four key sites: City of Hope in Los Angeles, the O’Neil Comprehensive Cancer Center in Birmingham, West Cancer Center in Memphis, and Mays Cancer Center in San Antonio. Each of these centers has built trusting relationships with underrepresented communities and can help bridge the gap of clinical trial inequity.

Dr. Sandoval closed by discussing Genentech’s Health Equity Innovation Fund, which is focused on investing in programs that prioritize inclusive research, patient equity and care, and workforce diversity. In 2020, 40 programs received innovation grants from Genentech, six of which were in Texas. The partnerships represented by the Health Equity Innovation Fund, as well as the Advancing Inclusive Research Site Alliance, represent collaboration between industry, payers, healthcare providers, patients, legislators, and more. It is these partnerships that will decrease barriers, and deliver equitable health care to the Latino community.