On September 16, 2024 Personalis, Inc. (Nasdaq: PSNL), a leader in MRD testing, reported findings presented this week at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain (Press release, Personalis, SEP 16, 2024, View Source [SID1234646691]). 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.
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Two studies were presented at ESMO (Free ESMO Whitepaper) 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 (Free ESMO Whitepaper) 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."