Dive Brief:
- Grail’s multi-cancer early detection test failed to meet its primary endpoint in a key study, sending the company’s shares tumbling about 50% in Friday trading on the Nasdaq.
- The NHS-Galleri trial evaluated annual screening with the Galleri MCED test in England’s National Health Service over three years in 142,000 asymptomatic participants aged 50 to 77.
- Grail said the study aimed to show reduced late-stage cancer diagnoses and an increased cancer detection rate to support national screening in England. A U.S. premarket approval application for Galleri, submitted earlier this month, includes data from the trial on test performance, clinical validation and benefit of detection at stages I through III, including reduction in stage IV cancer diagnoses, the company said.
Dive Insight:
Grail and its competitors hope to advance detection of early-stage cancer through tests that can screen for many cancer types from a single blood sample. But while the potential for multi-cancer early detection has generated much excitement, researchers are still working on validating MCEDs.
A study commissioned by the Agency for Healthcare Research and Quality, for example, found last year that there is insufficient evidence to support broad use of the tests in people who do not have symptoms.
No MCED tests have Food and Drug Administration approval for multi-cancer screening, but some, like Grail’s Galleri, are available in the U.S. as laboratory developed tests, a regulatory pathway that does not require FDA approval. Currently approved early detection tests can evaluate only single cancer types.
Grail, which DNA sequencing company Illumina bought for $8 billion but later divested under pressure from regulatory bodies, has been selling Galleri in the U.S. as an LDT since 2021.
Grail said the NHS-Galleri trial was designed to demonstrate population-level impact. However, the study failed to meet the primary endpoint of statistically significant stage III-IV reduction.
The data showed a favorable trend toward fewer stage III and IV cancers in a pre-specified group of 12 cancers in the screening arm, and adding Galleri to standard of care screening resulted in a clinically meaningful reduction in stage IV diagnoses compared with standard of care alone, the company said.
Grail CEO Bob Ragusa said in a statement that based on the reduction in stage IV cancer diagnoses and Galleri’s continued strong test performance metrics, the company planned to expand its sales and medical teams to increase education efforts for the test. Additional analyses are being performed on the data, the company added.
“The NHS-Galleri trial provides the strongest evidence to date that multi-cancer early detection can shift the stage at which cancers are detected at a population level,” Ragusa said.
TD Cowen analysts, however, called the study’s failure to meet its primary endpoint a major setback. While elements of the trial results are positive, the analysts said there are now risks to whether Galleri will gain FDA approval or Medicare coverage.
