The key clinical trial of a U.S. multi-cancer early detection corporations that Samsung backed with about 155 billion won in investment has failed. As a result, some say Samsung's plan to commercialize blood-based multi-cancer precision diagnostics could be put on hold.
U.S. blood-based multi-cancer screening corporations Grail said in a news release on the 19th (local time) that it failed to meet its primary endpoint in a large clinical trial of 140,000 people conducted in the United Kingdom. The primary endpoint is the key metric that determines the success or failure of a trial, and whether statistical significance is achieved is the watershed for approval and commercialization. The metric is pre-specified in the protocol submitted to regulators before the trial begins.
Grail has technology that selects micro-DNA associated with cancer from among hundreds of millions of DNA fragments in the blood and predicts whether cancer is present and even the organ location through artificial intelligence (AI)-based genomic analysis.
The multi-cancer early detection test "Galleri," which the company launched in 2021, is characterized by its ability to detect more than 50 types of cancer with a single blood test. The company expects that using Galleri will lead to more cancers being found at stages 1 and 2 and a lower rate of stage 3 and 4 diagnoses. It has secured a cumulative total of about 400,000 tests to date and has been conducting a large, three-year clinical trial with the United Kingdom's National Health Service (NHS), the health authority, to evaluate whether to introduce it into the national screening program.
However, in this trial of 140,000 people, diagnoses of stage 3 cancer increased, and the study failed to meet the primary endpoint that evaluates the combined number of late-stage cancers at stages 3 and 4. There was also no statistically significant difference between the trial and control groups. After the results were announced, Grail's share price plunged as much as 48.54%.
The trial failure has prompted observations that Samsung's business plans could also be hindered. In Oct. last year, Grail drew a total investment of $110 million (about 1.55 trillion won) from Samsung C&T and Samsung Electronics, drawing attention in Korea as well.
With that investment, Samsung C&T secured exclusive distribution rights for Galleri in Korea and had planned to expand cooperation to Singapore and Japan. Samsung Electronics is also reviewing a strategic partnership to link Grail's gene-based early detection data with its own health platform.
Blood-based disease prediction technology is a field that the Samsung group has strategically focused on. It is also active in securing early diagnostic technology for neurodegenerative diseases, not just cancer.
Samsung C&T also invested $10 million (about 145 billion won) in U.S. blood-based Alzheimer's testing corporations C2N Diagnostics through a life science fund jointly funded last year with Samsung Biologics and Samsung Epis Holdings' subsidiary Bioepis.
Samsung Electronics has also invested in U.S. DNA analysis equipment maker Element Biosciences to strengthen its healthcare business, and recently acquired U.S. Digital Healthcare corporations Xealth.
However, some in the market say the cooperation framework will not be shaken immediately. Galleri is currently under U.S. Food and Drug Administration (FDA) review for marketing approval, and Grail remains confident about the approval outlook. Recently, it also signed a sales contract with the digital health platform corporations HIMS and Hers.
Grail has been selling Galleri in the United States since 2021. Cumulative sales total 500,000, with about 185,000 sold last year. The test costs $949 (about 1.37 million won).
The U.K. trial was designed to detect cancer early at stages 1–2 and reduce the incidence of late-stage cancers at stages 3–4. The primary endpoint was the number of late-stage (stages 3–4) cancer diagnoses, with the ultimate goal of demonstrating a reduction in cancer mortality. A total of 142,000 people aged 50–77 participated over three years.
Grail says the results are only based on the U.K. NHS evaluation criteria, and that signals supporting Galleri's utility were still observed. The company said, "Incidence of stage 4 cancer in the trial group showed a tendency to decrease by more than 20% as the observation period lengthened," adding, "Compared to standard care, overall cancer (early and late) detection rates were more than quadrupled."
It also notes that in the test group, more stage 3 cancers were diagnosed due to early detection, while in the control group, cases may simply not have been diagnosed yet. It said the data could improve with an additional 6–12 months of follow-up. A company representative emphasized, "This is the first case in a randomized controlled trial where multi-cancer early testing showed signals of stage shift and reduced metastatic cancer at a population scale."
The industry sees that while Samsung has been accelerating ecosystem-building with blood-based early detection and Digital Healthcare as future growth pillars, this trial result has increased short-term uncertainty. However, Samsung is said to view FDA approval as a more important variable than these results.