GRAIL continues to drive progress in clinical evidence generation and commercial use of GalleriⓇ, a first-of-its-kind multi-cancer early detection (MCED) blood test. In a clinical study, Galleri has shown the ability to detect more than 50 types of cancer, most of which have no current screening. Since sharing interim results last year, GRAIL has completed a final analysis of PATHFINDER, a seminal interventional study of the implementation of Galleri, with data to be presented at the European Society of Medical Oncology (ESMO) Congress 2022, September 9-13.
In July, GRAIL completed enrollment in the NHS-Galleri trial, the largest study of an MCED test, in partnership with England’s National Health Service (NHS). The NHS-Galleri trial includes 140,000 healthy volunteers aged 50-77 in select regions throughout England who have not had a cancer diagnosis or undergone treatment for cancer in the last three years. Initiated in late August 2021, the NHS-Galleri trial completed full enrollment in just over 10 months. The collaboration between GRAIL and the NHS supports the NHS Long Term Plan to transform cancer care with three in four cancers diagnosed at an early stage by 2028.
Higher rates of late stage cancer diagnosis contribute to poorer outcomes for underserved communities. In recognition of the opportunity for MCED tests to impact these inequities, GRAIL is pursuing innovative partnerships to improve cancer early detection rates for underserved populations, and this quarter announced a collaboration with Ochsner Health to improve cancer detection.
Galleri’s launch continued to gain momentum in the second quarter, over which GRAIL entered a number of partnerships with stakeholders across the healthcare ecosystem to drive early detection of cancer. We have implemented the sales force expansion highlighted in our last business update in April, and we have seen growth in Galleri in clinics quarter-over-quarter, with a key driver the addition of new prescribers. We are also seeing growing traction in the employer market as customers leverage Galleri to support efforts to combat the rising cost of oncology treatment and address social determinants of health and disparities in cancer care among diverse employee populations. GRAIL also continues to expand into elevated risk populations, including firefighters and first responders, and is establishing local partnerships across the country, including the announced implementation of Galleri testing in the Westminster Fire Department in Colorado. In addition, we are encouraged by the successful launch of Galleri testing and pull through in health systems this quarter.
GRAIL continues to develop our pharmaceutical partnership business, and has announced our first companion diagnostic collaboration with AstraZeneca. This collaboration demonstrates the potential value of GRAIL’s proprietary methylation technology in applications following an initial diagnosis of cancer, such as prognosis, early disease recurrence monitoring, and assessment of minimal residual disease (MRD). We are also continuing to work with a number of biopharmaceutical partners in the research setting.
GRAIL has also made several key leadership additions in recent months with the appointment of Julie Currie as Chief People Officer, Andy Partridge as Chief Commercial Officer, Amoolya Singh, PhD, as Senior Vice President of Data Science and Chief Scientific Officer, and Jeff Venstrom, MD, as Senior Vice President of Medical Affairs and Chief Medical Officer. The addition of these seasoned executives to GRAIL’s leadership team supports continued technology innovation, commercial launch success and organizational effectiveness.
- In May, GRAIL and Intermountain Healthcare expanded the existing partnership to offer the Galleri test to eligible health system patients at elevated risk for cancer, such as adults over 50 years old or with additional risk factors. In addition, the test will be available to eligible employees and their families who are enrolled in a company-sponsored health plan.
- Also in May, GRAIL announced a collaboration with the U.S. Department of Veterans Affairs (VA) Veterans Health Administration, America’s largest integrated health care system, and the Veterans Health Foundation to provide Galleri to 10,000 veterans across approximately ten participating VA sites over the next three years. Through the collaboration, eligible U.S. military veterans will be able to receive the Galleri test and can enroll in GRAIL’s REFLECTION registry, an observational, multi-center, real-world evidence study. GRAIL is proud to serve America’s veterans, a population that is at higher risk of cancer and generally more diverse than the overall U.S. population.
- In June, GRAIL and Ochsner Health announced a multi-faceted partnership to improve cancer detection rates in Louisiana using Galleri. Ochsner, through a collaboration between its Ochsner Cancer Institute and Precision Medicine program, will offer the Galleri test by prescription to eligible patients in Louisiana to advance the delivery of cancer care. GRAIL and Ochsner’s partnership includes the launch of a MCED Health Equity Demonstration Program, an initiative to improve cancer detection rates for underserved populations in Louisiana and to develop a model for deployment of innovative technologies in community settings. In addition to deploying Galleri, the initiative includes identification of educational and access gaps and barriers to cancer screening, co-creation and development of patient education materials, and community outreach to improve awareness and education about early cancer detection.
- Also in June, GRAIL announced a broad strategic collaboration with AstraZeneca to develop and commercialize companion diagnostic (CDx) assays for use with AstraZeneca’s therapies. The collaboration will initially focus on developing companion diagnostic tests to identify patients with high-risk, early-stage disease, with plans to embark on numerous studies across multiple indications over the next several years.
- At the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in June, and as part of the collaboration between GRAIL and the NHS in England, GRAIL shared the study design of the NHS-Galleri trial. The study’s aim is to determine if the Galleri test, along with other standard cancer screenings, can find asymptomatic cancers at an early stage when they are less advanced, and people have a higher chance of successful and potentially curative treatment. It will assess absolute numbers of stage 3 and 4 cancers diagnosed at 3.5 years following randomization. Initial results of the study are expected in 2024, and if successful the NHS plans to extend the test rollout to an additional 1 million people.
- GRAIL and Fountain Health Insurance announced a partnership in June that will offer Galleri to Fountain Health customers at 100% coverage as part of its annual wellness benefits. Fountain provides coverage in large group health insurance, with a primary focus in keeping members healthy through preventative care.
- In June, GRAIL and Indianapolis-based Community Health Network announced a partnership to offer Galleri to individuals at Community Health Network’s sites of care. Community Health Network, central Indiana’s leading integrated healthcare system with more than 200 sites of care, will be the first healthcare system to offer the Galleri test to patients in its area.
- In July, GRAIL and Mercy Health, one of the largest health systems in the U.S., announced plans to offer the Galleri test. Mercy serves millions annually through its 900 physician practices and outpatient facilities, 3,400 Mercy Clinic physicians and advanced practitioners, and more than 40,000 co-workers serving patients and families across Arkansas, Kansas, Missouri and Oklahoma. Mercy also has clinics, outpatient services and outreach ministries in Arkansas, Louisiana, Mississippi and Texas.