SAGITTARIUS is Natera's first interventional trial using SignateraTM to select patients for targeted therapy in early-stage colon cancer

Approximately 700-900 patients expected to be enrolled across more than 20 sites

Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA and genetic testing, today 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, SAGITTARIUS is a global, randomized, phase III clinical trial designed to evaluate the use of Signatera to guide personalized adjuvant treatment strategies for patients with colon cancer.

The study aims to enroll approximately 700-900 stage III and high-risk stage II colon cancer patients following surgical resection.

• Signatera-positive patients will be randomized to receive either genotype-guided therapy tailored to their individual tumor mutational profile or six months of standard chemotherapy. The trial's investigational arm will explore the potential of administering immunotherapy or targeted agents approved for metastatic colon cancer earlier in the disease course to increase the proportion of patients cured with adjuvant therapy. This genomically-driven approach will focus on mismatch repair status, POLE, RAS/RAF mutation status, and HER2 amplification status.
• For Signatera-negative patients, the trial will compare physician choice treatments with options for de-escalation to observation or single-agent capecitabine for six months.

SAGITTARIUS includes collaborations with 9 partners in 5 countries in Europe, and a network of 26 clinical centers in Italy, Spain, and Germany.