Grail Cancer Test Fails UK Trial, Stock Plummets 50% – Samsung Investment Impacted
- A large-scale clinical trial of Grail’s ‘Galleri’ cancer early detection test conducted in the United Kingdom has failed to meet its primary evaluation indicators, sending shockwaves through the...
- Grail, a US-based biotech firm with investment from Samsung, developed Galleri to detect trace amounts of cancer cell DNA in the blood, aiming to diagnose approximately 50 different...
- The primary endpoint of the trial focused on the rate of stage 3 and 4 cancer diagnoses.
A large-scale clinical trial of Grail’s ‘Galleri’ cancer early detection test conducted in the United Kingdom has failed to meet its primary evaluation indicators, sending shockwaves through the biotechnology company and impacting its stock price. Shares of Grail (NASDAQ:GRAL) plummeted over 50% on , following the announcement of the trial results.
Grail, a US-based biotech firm with investment from Samsung, developed Galleri to detect trace amounts of cancer cell DNA in the blood, aiming to diagnose approximately 50 different types of cancer at an early stage. The UK trial, involving over 142,000 adults aged 50 to 77 over a three-year period, was designed to assess whether the test could reduce late-stage cancer diagnoses and increase early detection rates within the National Health Service (NHS).
The primary endpoint of the trial focused on the rate of stage 3 and 4 cancer diagnoses. The underlying hypothesis was that earlier cancer detection through Galleri would lead to a decrease in diagnoses at later stages. However, the study did not demonstrate a statistically significant reduction in these later-stage diagnoses, leading to the determination that the primary evaluation index was “not observed,” according to a company press release.
While the primary endpoint wasn’t met, Grail executives indicated during a conference call that the test may have accelerated cancer diagnosis overall. They also pointed to favorable trends in secondary indicators, such as a potential decrease in stage 4 diagnoses and an increase in stage 3 diagnoses, though these were not the primary focus of the evaluation.
The setback comes as Grail had recently filed for U.S. Food and Drug Administration (FDA) approval of Galleri, relying on earlier data from a U.S.-based study of roughly 25,000 participants and the initial year of data from the NHS trial. Despite the UK trial results, analysts suggest the FDA review process is likely to remain on track. However, the impact on coverage decisions by the Centers for Medicare and Medicaid Services (CMS) remains uncertain, as the agency may consider the NHS results when determining whether to cover the test.
Currently, Galleri is recommended for adults at elevated cancer risk and is already available for purchase in the United States since 2021, with cumulative sales nearing 500,000 units, including approximately 185,000 units sold last year. The test is priced at $949 per item, but is largely classified as an uninsured service by most insurance companies.
Grail took advantage of a regulatory loophole to begin selling Galleri in the U.S. Before receiving FDA approval. However, recent U.S. Legislation, signed into law in , included a provision allowing Medicare to recognize cancer diagnostic tests as covered benefits. This legislation had raised expectations that Galleri would be eligible for coverage, but the UK trial results have cast doubt on that prospect.
The financial impact of the trial failure was immediate, and substantial. Grail’s stock price experienced a dramatic decline, falling 50.55% to $50.21 on , and continuing to fall in after-hours trading, dropping below the $50 mark.
Samsung has also made a significant investment in Grail. In , Samsung C&T and Samsung Electronics invested $110 million (approximately 159 billion Korean Won) in the company. Samsung C&T secured exclusive rights to distribute Galleri in Korea, with plans for collaboration in Singapore and Japan. Samsung Electronics expressed intentions to integrate Grail’s technology and cancer early diagnosis data with the Samsung Health Platform to enhance health management experiences for users.
The failure of the UK trial underscores the challenges inherent in developing and validating multi-cancer early detection tests. While the promise of detecting cancer at earlier, more treatable stages is compelling, demonstrating a clear clinical benefit in large-scale trials remains a significant hurdle. The future of Galleri, and the broader field of liquid biopsy-based cancer screening, will depend on further research and the ability to demonstrate improved patient outcomes.