ESMO 2024 Data Expands on Compelling Performance of Personalis NeXT Personal® MRD Test

Rhea-AI Summary

Personalis, Inc. (Nasdaq: PSNL) presented compelling data at ESMO 2024 for its NeXT Personal® MRD test. Two studies showcased the test's effectiveness in lung cancer monitoring and immunotherapy response assessment. The TRACERx study, analyzing over 400 NSCLC patients, demonstrated strong detection rates for residual lung cancer post-surgery, with 42% of detections in the ultrasensitive range. The test showed high sensitivity in detecting early-stage recurrence months ahead of imaging. Another study by VHIO, involving 200+ late-stage cancer patients on immunotherapy, revealed that significant ctDNA level decreases correlated with longer overall survival. These findings underscore the importance of ultrasensitive MRD testing in cancer management and therapy response monitoring.

Positive

• NeXT Personal® MRD test shows strong detection rates for residual lung cancer in the first 120 days after surgery
• 42% of landmark detections occur in the ultrasensitive range (less than 80 ppm)
• High sensitivity for detecting early-stage lung cancer recurrence months ahead of imaging
• Ability to stratify patients for clinical outcomes through dynamic monitoring during adjuvant therapy
• Significant ctDNA level decreases in response to immunotherapy correlated with longer overall survival

Negative

• None.

Oncology Researcher

This study significantly advances our understanding of minimal residual disease (MRD) detection in lung cancer. The NeXT Personal assay's ultra-sensitive detection capabilities (80 ppm) are particularly noteworthy. The ability to detect ctDNA in 42% of cases within this range during the landmark period is remarkable. This could revolutionize post-surgical monitoring and potentially guide adjuvant therapy decisions.

The correlation between pre-operative detections and clinical outcomes in lung adenocarcinoma is a critical finding. It suggests the potential for more personalized treatment strategies based on pre-surgical ctDNA levels. Furthermore, the assay's capacity to stratify patients for clinical outcomes through dynamic monitoring during adjuvant therapy could be a game-changer in tailoring post-surgical care.

Medical Research Analyst

The expanded TRACERx study, with over 400 NSCLC patients, provides robust evidence for the clinical utility of ultra-sensitive MRD testing. Key findings include:

• High detection rates in the critical 120-day post-surgery period
• Predictive value of pre-operative detections for lung adenocarcinoma outcomes
• Early detection of recurrence, months ahead of imaging

These results suggest potential for significant improvements in patient care and outcomes. The ability to identify high-risk patients early could lead to more aggressive interventions, while low-risk patients might be spared unnecessary treatments.

The immunotherapy study's validation of ctDNA reduction as a predictor of overall survival is equally impactful, potentially offering a valuable tool for monitoring treatment efficacy in late-stage cancers.

Financial Analyst

The expanded data from these studies significantly bolster Personalis's market position in the rapidly growing MRD testing sector. The robust performance of NeXT Personal across multiple studies enhances its credibility and potential for widespread adoption. This could translate into substantial revenue growth for Personalis, especially considering the recent launch and partnership with Tempus AI.

The test's demonstrated utility in both early-stage cancer monitoring and late-stage immunotherapy response assessment broadens its potential market. This versatility could be a key differentiator in a competitive landscape. Investors should note the potential for increased market share and possibly accelerated revenue growth if these clinical advantages lead to broader adoption in oncology practices. However, the company's ability to scale operations and navigate reimbursement landscapes will be important for capitalizing on these promising results.

Results continue to demonstrate the importance of ultra-sensitive ctDNA detection in lung cancer and immunotherapy

FREMONT, Calif.--(BUSINESS WIRE)-- Personalis, Inc. (Nasdaq: PSNL), a leader in MRD testing, announced findings presented this week at the European Society of Medical Oncology Congress (ESMO) Congress 2024 in Barcelona, Spain. Personalis’ NeXT Personal assay was designed to detect and monitor residual and recurrent disease (MRD) in cancer patients by detecting very small traces of circulating tumor DNA (ctDNA) in the blood. It was launched to the clinic in late 2023 and is being co-commercialized in partnership with Tempus AI, Inc.

Two studies were presented at ESMO further demonstrating the importance of using ultrasensitive MRD assay to monitor lung cancer patients and patients on immunotherapy.

In the first of these studies, Professor Charles Swanton and his colleagues at Cancer Research UK, University College London and the Francis Crick Institute analyzed over 400 non-small cell lung cancer (NSCLC) patients from their TRACERx lung cancer study, using the NeXT Personal assay. It represents one of the largest and most comprehensive MRD studies in lung cancer performed to date. These new results expand on and further strengthen the ground-breaking results of the initial study presented at last year’s ESMO congress.

• Strong detection rates for residual lung cancer in the landmark period, the first 120 days after surgery
• A high percentage of these landmark detections (42%) occur in the ultrasensitive range (less than 80 ppm) enabled by NeXT Personal
• Pre-operative detections predict clinical outcome in lung adenocarcinoma, the most common type of lung cancer
• Dynamic monitoring with NeXT Personal through adjuvant therapy can stratify patients for clinical outcome

NeXT Personal demonstrated high sensitivity for detecting early-stage lung cancer recurrence with detection months ahead of imaging and the ability to identify low and high-recurrence risk patients before and after surgery.

In the second abstract, Dr. Rodrigo Toledo at the Vall d'Hebron Institute of Oncology (VHIO) presented data on a large cohort of over 200 late-stage cancer patients on immunotherapy profiled using the NeXT Personal assay, significantly expanding on the initial cohort first presented earlier this year. The study was unique in having a validation set of patients and it demonstrated that patients who had a significant decrease in ctDNA levels in response to immunotherapy had significantly longer overall survival than those who did not.

“The expanded data from the TRACERx and VHIO studies are important for demonstrating the robust performance and clinical importance of our NeXT Personal MRD test,” said Richard Chen, Chief Medical Officer and EVP of R&D at Personalis. “There are now 6 studies that have been presented pointing to a critical role of an ultra-sensitive MRD approach for identifying patients at risk for cancer recurrence, monitoring therapy response, and detecting cancer recurrence earlier.”

About Personalis, Inc.

At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and Twitter.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release that are not historical are “forward-looking statements” within the meaning of U.S. securities laws, including statements relating to the attributes, advantages, sensitivity, performance or clinical importance of the NeXT Personal test. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to the ability of NeXT Personal to detect very small traces of ctDNA in blood, detect residual or recurrent cancer earlier, monitor a patient’s response to therapy, or more accurately predict clinical outcomes for cancer patients, or to the clinical adoption or use of, or reimbursement for, the NeXT Personal test. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Personalis’ Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (SEC) on February 28, 2024, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 7, 2024. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240916809873/en/

Investors:

Caroline Corner

investors@personalis.com

415-202-5678

Media Contact

pr@personalis.com

Source: Personalis, Inc.

FAQ

What were the key findings of the TRACERx study using Personalis' NeXT Personal MRD test for NSCLC patients?

The TRACERx study, analyzing over 400 NSCLC patients, showed strong detection rates for residual lung cancer post-surgery, with 42% of detections in the ultrasensitive range. The test demonstrated high sensitivity in detecting early-stage recurrence months ahead of imaging and could identify low and high-recurrence risk patients before and after surgery.

How did the VHIO study using Personalis' NeXT Personal MRD test impact immunotherapy patients?

The VHIO study, involving over 200 late-stage cancer patients on immunotherapy, revealed that patients with significant decreases in ctDNA levels in response to immunotherapy had significantly longer overall survival compared to those who did not show such decreases.

What is the significance of the ultrasensitive range in Personalis' NeXT Personal MRD test for PSNL stock?

The ultrasensitive range (less than 80 ppm) of the NeXT Personal MRD test is significant for PSNL stock as it demonstrates the test's superior capability in detecting very small traces of circulating tumor DNA. This high sensitivity could potentially lead to earlier cancer detection and more effective treatment monitoring, potentially increasing the test's market value and adoption.

How many studies have been presented supporting the clinical importance of Personalis' ultrasensitive MRD approach?

According to Richard Chen, Chief Medical Officer and EVP of R&D at Personalis, there are now 6 studies that have been presented pointing to a critical role of an ultra-sensitive MRD approach for identifying patients at risk for cancer recurrence, monitoring therapy response, and detecting cancer recurrence earlier.