Natera enrolls 1st patients in SAGITTARIUS clinical trial in colon cancer

Natera (NTRA) 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 resectio. 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. “The enrollment of the first patients in SAGITTARIUS represents a significant milestone in a trial that has the potential to transform treatment approaches for colorectal cancer,” said Silvia Marsoni, MD, PhD, head of the precision oncology unit at IFOM ETS and scientific coordinator of the SAGITTARIUS Project. “The trial aims to move beyond the traditional one-size-fits-all, post-surgical standard of care with chemotherapy by introducing a truly personalized treatment approach tailored to each patient,” said Adham Jurdi, MD, senior medical director of oncology at Natera. “Signatera-positive patients will receive adjuvant therapies matched to their specific mutational profiles.