Grail’s shares plummeted more than 45% after-hours Thursday as the medtech revealed a major National Health Service (NHS) trial of its Galleri test missed its primary endpoint.
In top-line data revealed alongside its full-year financial results Feb. 19, Grail said in a release that the eagerly anticipated NHS-Galleri trial didn’t show a statistically significant reduction in later-stage (3 and 4) combined cancers among people who received the Galleri test compared with those who did not.
Grail did, however, look for the positives and found that there was “a favorable trend toward fewer stage III-IV cancers in a pre-specified group of 12 deadly cancers in the intervention arm after the prevalent screening round.”
The deadly disease types included in the prespecified group were cancers of the anus, bladder, colorectal, esophagus, head and neck, liver/bile duct, lung, lymphoma, myeloma/plasma cell neoplasm, ovary, pancreas and stomach.
A detailed breakdown of the data was not shared. This will come at this year’s American Society of Clinical Oncology conference.
The study was set up as an annual multicancer screening with Galleri in England’s NHS over three years in 142,000 participants ages 50 to 77.
Drilling down into the data, the company found that adding Galleri to standard-of-care screening “resulted in a substantial and clinically meaningful reduction in stage IV diagnoses compared with standard of care alone across the pre-specified group of 12 deadly cancers.”
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It also found that stage 4 diagnoses in these cancers “decreased with each year of sequential screening, with a greater than 20% reduction in the second and third rounds. Similar reductions were observed across all cancers.”
There was also a “substantial increase in the absolute number of stage I-II cancers in the 12 pre-specified deadly cancer types that are typically found in late stages were observed in the intervention arm.”
With the findings in hand, Grail said it “plans to extend the trial’s follow up period by 6-12 months” in order to look “for a stronger effect with longer follow up as data matures.”
The trial is a key part of the company’s attempt to gain FDA approval. It sells its test commercially, but a regulatory green light in the U.S. would vastly broaden its selling and reimbursement potential.
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The study is also key to a potential national screening program in the U.K. if the results pass muster.
Bob Ragusa, CEO of Grail, was not put off by the results and said in a statement that his company will be “expanding field-based sales and medical teams to bolster our education efforts and support growing demand.”
Grail also announced that its full-year sales were up 17% year over year to $147.2 million, while U.S. Galleri revenue grew 26% year over year to $136.8 million.
