On October 22, 2023 Personalis, Inc. (Nasdaq: PSNL), a leader in precision oncology, reported the presentation of initial findings from its work with the groundbreaking TRACERx lung cancer study, marking a substantial advancement in lung cancer circulating tumor DNA (ctDNA) detection and management (Press release, Personalis, OCT 22, 2023, View Source [SID1234636232]). The Personalis NeXT Personal cancer assay, created to detect and monitor residual and recurrent disease (MRD), demonstrated significantly improved detection rates for early-stage lung cancer, including lung adenocarcinoma (LUAD), one of the most common and challenging subtypes of non-small cell lung cancer (NSCLC) to identify in blood samples.

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The findings come from an analysis by Professor Charles Swanton, Dr. James Black, and other members of the TRACERx consortium, renowned for their work on the complexities of cancer genomics. The findings were presented by Dr. Black at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress on October 21 in Madrid, Spain, and are the first publicly presented results from Personalis’ collaboration with Cancer Research UK’s Cancer Research Horizons, University College London (UCL), and the Francis Crick Institute.

Lung cancer is the second most common cancer in the U.S., with an estimated 238,000 new cases and approximately 127,000 deaths forecasted for 2023. The current standard of care for relapse detection of NSCLC, the most common type of lung cancer, is primarily focused on imaging modalities such as CT scans, which are known to be limited in sensitivity. This ongoing collaboration is focused on addressing this challenge through advanced ctDNA analysis. For the current analysis, the teams used NeXT Personal to identify and track MRD in over 170 patients from the TRACERx cohort.

Higher sensitivity for early-stage lung cancer

In this analysis, NeXT Personal showed significantly higher sensitivity in early-stage NSCLC patients compared to two previous publications on the TRACERx cohort. Pre-surgery, the assay demonstrated 100% sensitivity for ctDNA in pre-surgical non-LUAD samples and 81% pre-surgical ctDNA sensitivity for LUAD, one of the most common types of lung cancer but also one of the most challenging to detect in blood. The pre-surgical sensitivity for early-stage LUAD was up to 4X higher than in previous studies on the TRACERx cohort, depending on stage. This high sensitivity enhanced the assay’s ability to detect recurrence and monitor lung cancer effectively.

Ability to identify low and high recurrence risk prior to surgery

The study demonstrated that pre-surgical ctDNA levels with NeXT Personal could be used to classify early-stage lung cancer patients into lower- and higher-recurrence risk groups. Furthermore, the analysis showed that the ultra-low levels of ctDNA detection enabled by NeXT Personal were critical to determining patient recurrence risk. For example, LUAD patients who were ctDNA-negative before surgery with NeXT Personal strikingly exhibited a 100% 5-year overall survival rate and 94% relapse-free survival rate in the TRACERx cohort. In comparison, patients who were ctDNA-positive prior to surgery had a high risk of cancer recurrence over 5 years.

Earlier detection for earlier potential intervention

The results presented at ESMO (Free ESMO Whitepaper) also showed that NeXT Personal enabled earlier detection of residual or recurrent lung cancer after surgery in the TRACERx cohort. The results show a median lead time of approximately 6 to 11 months for ctDNA detection ahead of traditional imaging, and significantly longer than previous TRACERx results. The ability to identify potential recurrence months earlier offers the possibility to intervene and accelerate treatment in high-risk patients.

The promise of helping lung cancer patients throughout their journey

Overall, the TRACERx results raise the potential of using NeXT Personal to help inform patient management throughout the patient journey, from pre-surgery to post-surgery and longer-term monitoring.

"Existing tests for lung cancer patients often fall short in detecting residual or recurrent cancer early. Our NeXT Personal test is designed to change that by being significantly more sensitive. We are thrilled that the TRACERx results presented at ESMO (Free ESMO Whitepaper) demonstrated higher sensitivity for the most common types of early-stage lung cancer, including the most challenging subtypes. That sensitivity translated into a better understanding of recurrence risk for patients, and earlier detection of recurrence. We hope that earlier detection can ultimately be life-saving, offering patients a greater chance at successful treatment," said Richard Chen, MD, MS, Chief Medical Officer and Executive Vice President, R&D of Personalis.

The NeXT Personal technology leverages whole genome sequencing and advanced noise suppression with NeXT SENSE technology to identify a unique genetic signature derived from a patient’s tumor based on up to ~1,800 variants. This unique signature is tracked in the patient’s blood over time to find residual or recurrent cancer, achieving an industry-leading sensitivity of down to ~1 PPM. This enhanced sensitivity offers the potential for earlier recurrence risk assessment and intervention, earlier detection, more precise monitoring, and substantial advancement in lung cancer care.

"Patients often live in fear of undetected cancer leading to a relapse. Our new assay is a transformative leap forward—it’s like turning on a spotlight in a previously dark room. It finds what other tests often miss, providing a new level of certainty and peace of mind. This isn’t just about technology; it’s about giving patients and their families a clearer path forward in their fight against cancer," said Chris Hall, President and CEO of Personalis.

Webcast and Conference Call Information

Personalis will host a conference call on Tuesday, October 24, 2023 at 6:00 a.m. Pacific Time / 9:00 p.m. Eastern Time. The live webinar, which includes presentation slides, can be accessed here, or at View Source A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.