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Natera Launches SAGITTARIUS Trial to Personalize Colon Cancer Treatment with Signatera

NextEdge Admin

13 Dec 2024

2 min 42 sec

cell-free DNA,genetic testing,colorectal cancer

Natera, Inc. , a leader in cell-free DNA and genetic testing, announced the enrollment of the first patients in the SAGITTARIUS clinical trial. Sponsored by The AIRC Institute of Molecular Oncology (IFOM-ETS) and funded by the European Union Horizon Europe Programme, this global, phase III trial aims to evaluate the use of Signatera to guide personalized adjuvant treatment strategies in colon cancer.

The trial will enroll 700-900 stage III and high-risk stage II colon cancer patients post-surgery. For Signatera-positive patients, treatment will be randomized between standard chemotherapy and genotype-guided therapy tailored to each tumor's mutational profile. The study explores early use of immunotherapy or targeted agents, focusing on mismatch repair, POLE, RAS/RAF mutations, and HER2 amplification, to potentially increase cure rates.

Signatera-negative patients will compare physician-directed treatment with options for de-escalation, including observation or single-agent capecitabine. This approach seeks to reduce overtreatment while maintaining efficacy.

SAGITTARIUS involves nine partners across five European countries, with 26 clinical centers in Italy, Spain, and Germany. Dr. Silvia Marsoni, scientific coordinator, highlighted the trial's potential to revolutionize post-surgical colorectal cancer care by replacing standard chemotherapy with personalized strategies. Dr. Adham Jurdi of Natera emphasized the trial’s goal to validate targeted adjuvant therapies for Signatera-positive patients and support chemotherapy de-escalation for Signatera-negative cases.

Dr. Clara Montagut, principal investigator, noted the trial's pioneering use of molecular profiling to adapt adjuvant treatments, leveraging therapies effective in metastatic settings.

Signatera is a tumor-informed molecular residual disease test that uses circulating tumor DNA to detect cancer recurrence early, enabling optimized treatment decisions. It is clinically validated across multiple cancers and covered by Medicare for several indications, including colorectal cancer.