On September 3, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported new data from an AstraZeneca phase 3 clinical trial in lung cancer (NeoADAURA) (Press release, Personalis, SEP 3, 2025, View Source [SID1234655743]). The findings demonstrate that Personalis’ highly sensitive molecular residual disease (MRD) test, NeXT Personal, is a strong predictor of outcomes in patients with stage II-IIIb, EGFR-mutated non-small cell lung cancer (NSCLC) receiving neoadjuvant therapy.
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The findings, which will be presented at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain on September 7 (abstract OA02.02), demonstrate that NeXT Personal can be a more sensitive and accurate measure of MRD in the neoadjuvant setting. This supports findings in other cancer types that NeXT Personal can help doctors understand how patients are responding to neoadjuvant therapy, with the potential to guide future treatment decisions.
Key findings about NeXT Personal from the new NeoADAURA analysis:
More sensitive: NeXT Personal demonstrated significantly higher baseline sensitivity for ctDNA detection compared to another gene-mutation based test, providing a more accurate assessment of disease burden.
Prognostic: Baseline MRD status, as determined by NeXT Personal, was a strong prognosticator of clinical outcomes across all treatment arms.
Associates with pathological response: Pre-surgical MRD negativity and clearance on the NeXT Personal test were shown to be associated with major pathological response (MPR).
Useful for monitoring treatment: Osimertinib-containing regimens improved pre-surgical MRD clearance vs pbo+CT, showing the utility of ctDNA for monitoring neoadjuvant therapy response.
"The NeoADAURA results are a significant step forward for patients with early-stage lung cancer," said Richard Chen, Chief Medical Officer and EVP of R&D at Personalis. "This study from AstraZeneca shows that ultra-sensitive ctDNA detection enabled by NeXT Personal is critical for accurately assessing neoadjuvant treatment response. It also highlights how more-sensitive detection of ctDNA can unlock crucial insights in the neoadjuvant setting. We are proud to continue our productive relationship with AstraZeneca as we work to advance the frontier of cancer care."
The NeoADAURA trial (NCT04351555) is a global, randomized, placebo-controlled, double-blind, multi-center study of neoadjuvant osimertinib with or without chemotherapy versus placebo plus chemotherapy for patients with resectable EGFRm NSCLC.
This collaboration also builds on previous work with AstraZeneca showing the importance of highly sensitive ctDNA analysis for tracking treatment response and predicting cancer recurrence. This includes a recent publication of Phase 3 CALLA cervical cancer study results showing that NeXT Personal detected traces of cancer DNA in patients with locally advanced cervical cancer up to ~16 months ahead of standard of care imaging.
The NeoADAURA data presentation follows Personalis’ recent submission for Medicare coverage for its NeXT Personal liquid biopsy test for use in patients with lung cancer. This marks the third indication for which the company is seeking coverage for its ultra-sensitive, whole-genome-based, tumor-informed molecular residual disease (MRD) and recurrence test.