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UK NHS Declines to Accelerate Grail Galleri Implementation Following Early Data Review

NEW YORK – The UK National Health Service said Wednesday that it will not be accelerating the implementation of Grail's Galleri multi-cancer early detection test, following a review of data from the first year of their clinical study.

"NHS England has reviewed preliminary data from the first year of the NHS-Galleri trial and did not find them compelling enough to justify proceeding straightaway with a large-scale pilot program of the test in NHS clinical practice, while we await the final results of the trial," Peter Johnson, national clinical director for cancer at NHS England, wrote in a blog post.

"Committing to accelerate implementation of the test in the NHS at scale would have been an exceptional step, requiring exceptional data after just one year, and while what we have seen is very promising, the data so far do not support moving at such a fast pace," Johnson added.

NHS will instead wait for the full results from the three-year study, expected in 2026, before deciding on whether to begin implementing Galleri across the country.

"This early look at certain selected metrics provides only a limited view," Grail President of Biopharma Business & Europe Harpal Kumar wrote in a separate blog post. "As demonstrated in previous cancer screening trials, results from the first screening round do not always reflect the final results, especially for reduction in late stage diagnosis. In the US National Lung Screening Trial (NLST) for example, participants underwent three annual screenings. Ultimately, the trial demonstrated a significant relative reduction in mortality for those who received low-dose CT screening. However, no reduction in stage IV cancers was observed after the first year of screening. This is because a prevalent screening round often includes many asymptomatic cancers in later stages that have not been 'swept out' by that first year of screening."

The decision comes just weeks after Grail officials touted it as a potential positive catalyst for the firm as it prepares to be divested by Illumina. In a May 13 event for investors and stock analysts, Kumar suggested that the NHS decision would come sometime this summer.

"This is really bad timing and [a favorable decision from NHS] would have been a big part of the valuation for Grail," said Kyle Mikson, an analyst at Canaccord Genuity. Investors who had been bullish on what divesting Grail would do for Illumina had been "banking on" NHS to help boost Galleri sales and accelerate regulatory approval in the US, he said. Illumina is working to finalize the terms of its divestment by the end of June, and Grail may need to update certain documents filed with the Securities and Exchange Commission if Illumina chooses to do an IPO.

In Wednesday afternoon trading on the Nasdaq, shares of Illumina fell 3 percent to $101.76.

While Grail disclosed the data "snapshot" review in a March blog post, it had not been "baked into investor expectations," according to Subbu Nambi, an analyst for Guggenheim Securities who attended the May investor presentation.

Though both Johnson and Kumar touted promise in the early data, Nambi said that at least some investors could view the decision negatively. However, such a response could be an overreaction. "These are complex scientific studies, and the likelihood of achieving robust interim data is unrealistic in most cases," she said.

In an email, a Grail spokesperson said that "the clinical performance of Galleri was very promising — consistent with, or better than, Galleri's clinical performance observed in previously published studies" but did not provide additional detail. Grail did not respond to questions about when it submitted the data snapshot to NHS and when NHS informed it that it would not be accelerating Galleri implementation.

Earlier this month, Kumar told investors and analysts that Grail would present NHS with data on positive predictive value, the number of stage IV cancers found, and total cancers found over the first year of the study. These are not the primary endpoints of the study, NHS's Johnson noted.

"The NHS-Galleri trial was designed with three consecutive years of screening, and it is vital to evaluate the primary objective and endpoints at the end of the study in 2026," he wrote. "The primary endpoint of the trial is an absolute reduction in the number of late-stage (stage III and IV) cancers diagnosed, and cancer-specific mortality will also be analyzed after five years of follow-up."

"Many successful cancer screening trials have failed to show a stage shift initially," he added, "and it is frequently observed that the first-year data will differ from the final trial results."