NEW YORK – Guardant Health said this week that it still believes it can complete recruitment for its ongoing, prospective ECLIPSE study of its colorectal cancer early detection assay within a previously stated timeline of about 24 months.
This is despite significant changes caused by the COVID-19 pandemic in recent months that have led to fewer patients being offered routine procedures like colonoscopies, which are an eligibility requirement for the study.
With a significant milestone achieved this week when the company's Guardant360 CDx assay — a test designed to genotype advanced cancers and inform targeted therapy — received US Food and Drug Administration approval, Guardant is now firmly transitioning into a new period focused on early-stage cancers and cancer detection.
In a call discussing the firm's second quarter financial results on Thursday, Guardant CEO and Cofounder AmirAli Talasaz said that the company's research and development efforts behind the Lunar-2 test being validated in ECLIPSE, as well as a second assay, Lunar-1 — designed for disease monitoring and recurrence detection in the adjuvant setting — are moving forward "at relatively full capacity."
Coming out of March and April, Guardant had previously said that it was seeing reductions and deferrals of elective procedures in order to preserve resources for COVID-19 patients and protect vulnerable patients from coronavirus exposure. This raised uncertainty about how recruitment for the ECLIPSE trial, which targets individuals being referred for routine colonoscopy, would be affected.
However, this week the company said that although there was a slowdown in recruitment, patient enrollment has reaccelerated as the summer has progressed, with the trial now including 130 sites.
"We continue to believe we will complete enrollment within the 24-month timeframe announced last November," Talasaz said.
"During the days that patient enrollment first slowed down because of COVID we put a lot of energy behind bringing new sites on [and] by end of this quarter we are going to basically reach our 150-site target," he added.
Outside of Eclipse, which is prospectively assessing the Lunar assay for early detection, Guardant is also continuing its internal efforts to optimize and analytically validate the technology.
Talasaz highlighted a presentation that the firm made at the recent annual meeting of the American Association for Cancer Research, which applied Lunar to a new case-control cohort, demonstrating "improved performance" in detecting early-stage CRC.
"Our assay achieved 90 percent sensitivity and 94 percent specificity … and even higher specificity when restricting analysis to controls who were negative for CRC by colonoscopy," Talasaz said.
Both the Lunar-2 early detection and Lunar-1 monitoring programs are using a method Guardant developed that combines detection of genomic alterations and epigenomic signals, including methylation and DNA fragmentation patterns.
Regarding Lunar-1, the company has said that various biopharmaceutical partners have adopted the technology, which it currently markets for research use only, in adjuvant drug research.
The firm is also involved in two recently announced trials of its own in this area. The first, COBRA, was described this January and is evaluating whether the use of Guardant's multi-omic Lunar technology to guide adjuvant treatment decisions for stage II colorectal cancer patients can improve their outcomes over current standard of care.
A second prospective interventional study, in collaboration with Stand Up 2 Cancer, Massachusetts General Hospital, and Dana-Farber Cancer Institute, is following stage III CRC patients with a similar goal.
Talasaz said this week that Guardant has also been working to expand its efforts around this Lunar-1 residual disease monitoring application from colorectal-cancer specific to pan-cancer applications and is making "solid progress" there.
Although the company faces competitors in the early detection space, these players are largely, like Guardant, still validating or preparing to validate their assays in studies similar to ECLIPSE.
But in the Lunar-1 adjuvant setting, companies like Natera and Inivata have already launched residual disease detection and monitoring assays for clinical use.
According to Talasaz, Guardant's belief is that what remains most sorely lacking in this emerging minimal residual disease or MRD space, is clear data proving that liquid biopsy tests not only identify patients at a high risk of recurrence, but that in doing this, they also improve these individuals' lives or outcomes.
This clinical utility evidence is going to be crucial to accelerating clinical adoption of this type of testing, he argued.
As a result, Talasaz said, Guardant has decided to "prioritize clinical evidence generation over just putting something out on the market … and then trying to convince everybody why it's good for patients to use the device while clinical utility is still a question."
This could mean a longer path to the clinic for a non-RUO version of Lunar-1, but the company believes that its technology offers advantages that will be a boon if and when it does move this assay into clinical use.