GRAIL, a healthcare company, has shared the final results of its groundbreaking PATHFINDER study. This Phase 3 clinical trial focused on multi-cancer early detection (MCED) screening using a blood test and the subsequent clinical pathways for individuals aged 50 and above, a demographic at higher risk of cancer. Presented at the ESMO Congress 2022 in Paris, these findings could herald a transformative era in cancer care.
The PATHFINDER study aimed to determine the time needed for diagnostic resolution following a "cancer signal detected" MCED blood test result, along with the types of diagnostic tests employed. MCED test performance, including positive predictive value (PPV) and the accuracy of predicted cancer signal origin (CSO), was also scrutinized. Over a 12-month tracking period, participants were observed for cancer development after a negative MCED test at enrollment.
The results were assessed using both an earlier version of Galleri (MCED-E) and a refined version of Galleri (MCED-Scr). The earlier version was adjusted to improve prediction accuracy and reduce pre-malignant hematologic conditions detection. MCED-E was used initially, followed by retesting blood samples with MCED-Scr in a pre-specified retrospective analysis.
Out of 92 participants with a cancer signal, 35 were diagnosed with 36 cancers, including 71% with no standard screening. Encouragingly, 48% of non-recurrent cancers were found in early stages (Stage I or II). Traditional screenings identified 29 cancers, while 56 more were diagnosed due to symptoms or incidental findings.
The accuracy of cancer signal origin prediction reached 97%, enabling swift diagnostic resolution for most participants with a true positive signal. However, false positives took longer to resolve, with a median time of 162 days. This was mainly due to delayed follow-up imaging or procedures, affecting 44% of false-positive cases.
Participant-reported outcomes indicated a high satisfaction rate of 97.1% with the MCED test, even among those with true positive and false-positive results. Anxiety levels were understandably higher for positive results but returned to baseline within a year.
The refined Galleri test demonstrated a PPV of 43.1%, a specificity of 99.5%, and a false positive rate of less than 1%. These results aligned with earlier analyses and the Circulating Cell-free Genome Atlas (CCGA) study.
Source: GRAIL. "GRAIL Announces Final Results From the PATHFINDER Multi-Cancer Early Detection Screening Study at ESMO Congress 2022". https://grail.com/press-releases/grail-announces-final-results-from-the-pathfinder-multi-cancer-early-detection-screening-study-at-esmo-congress-2022/. 11/09/22 [Date accessed: 12/09/22].
Edited by: Arnav Dhavale
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