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Guardant Health Hopes Lung Cancer Stakeholder Alignment Will Help Advance Liquid Biopsy Goals


NEW YORK – Liquid biopsy firm Guardant Health hopes that a new alignment of stakeholders in the lung cancer space called the Lung Ambition Alliance, which launched last week, may ease the path for its liquid biopsy approach, which has been shifting from tumor profiling toward therapy monitoring and cancer screening.

Members of the new alliance — AstraZeneca, the International Association for the Study of Lung Cancer (IASLC), and the Global Lung Cancer Coalition (GLCC), are all groups that Guardant already had a relationships with. But President and Chief Operating Officer AmirAli Talasaz said that pledging formally to join forces for a shared goal — doubling five-year survival by 2025 — is a significant step.

"What excited us to be part of this when we heard about it was that the ambition of the group was really matching the ambition we have as a company and our commitment to improving the lives of cancer patients," Talasaz said.

Guardant has already made strong progress in its own goals around advancing liquid biopsy, but "we can't we do it alone," he added. "The reality is that there is complementary expertise here. With IASLC, AstraZeneca, and patient advocacy groups like GLCC, it's vast what they can offer in order to make sure that the advancements we make [in drugs and diagnostics] are guided in the right direction, and that there is the needed awareness around these advances."

The alliance involves a handful of different projects, some of which are unrelated to liquid biopsy and genomic biomarkers. For Guardant, the most relevant arm right now is what the alliance calls the Major Pathologic Response Project.

The goal of this program is to validate surrogate endpoints — for Guardant, circulating tumor DNA mutations and epigenetic signals — that can aid drug development and hopefully direct new strategies to personalize the treatment of earlier-stage patients in some of the same ways targeted therapies have transformed the care of late-stage lung cancer.

More specifically, the hope is that liquid biopsy approaches like Guardant's could solve the riddle of which early-stage patients are effectively cured by surgery and which need added treatment. Such information not only stands to aid clinical practice but also gives drug companies a way to strategically and more quickly test new adjuvant therapies — only trying a treatment on those that will likely benefit from it and not muddying the water of the analysis with already-cured patients.

Talasaz said distinct plans have been discussed for what the pathologic response program will entail but the group can't discuss them in detail yet. In general, though, the team will be working to "really see if we can use liquid biopsy, to prove that you can assess the efficacy of the drug just a few weeks after start of a treatment with a simple blood test," he said.

In its own data, the company has begun to demonstrate with academic partners that its epigenomic and mutation-based Lunar assay technology can anticipate or predict recurrences. A study in colorectal cancer presented earlier this year, for example, yielded a negative predictive value of 80 percent in anticipating a lack of future recurrences.

To reach its stated goal of doubling lung cancer survival over the next six years, LungAmbition has also staked a claim in improving cancer screening — in order to make sure clinicians are detecting more lung tumors at the early stages that the Pathologic Response Project then hopes to address.

As described right now, the alliance's plans in this vein are limited to improving existing imaging techniques and increasing patient adherence to imaging. The group hopes to bolster and grow an IASLC archive of CT lung cancer images that researchers could mine and analyze to develop better detection strategies, for example.

That said, the alliance's webpage also states that it supports "further development of blood biomarkers that aim to increase diagnostic accuracy and streamline diagnosis."

"With low-dose CT, the reality is that the awareness is not that high and compliance rates are extremely low … so we are excited to join forces in increasing awareness of screening programs that exist … But we also believe liquid biopsy can improve current standard of care," Talasaz said.

"The first activity around screening that is being launched right away is using imaging, but you could imagine we are going to try to contribute using liquid biopsy … as this partnership develops and we make more progress developing our test," he added.

Finally, Talasaz said, Guardant believes that part of the push to double five-year survival may require not just work in the early-cancer and cancer screening sphere but also efforts by the four partners to improve the use of already-available therapies and genetic tests for advanced patients.

As Guardant has emphasized in other recent announcements, it believes evidence is growing that use of its existing liquid biopsy genotyping test Guardant360 can help make sure more patients get tested, get targeted treatment, and get that treatment faster.

"Patients continue to be under-genotyped and as a result, they are not getting optimal treatment," Talasaz said. "We believe what we are offering has tremendous value [to help resolve this] based on what we have seen so far."

Since the alliance was announced, prospective new partners have already approached the four founders about joining, and there is an "open invitation" for others, Talasaz said.

In terms of funding, the four founding partners have committed to "share and dispense expertise and funding on a continual basis," he added. How that will work out for specific programs under the alliance, and the actual levels of funding, will be determined on a case-by-case basis.