Natera announced updated data from GALAXY arm of CIRCULATE-Japan trial

Natera announced updated data from the GALAXY arm of the CIRCULATE-Japan trial further showcasing the ability of the Signatera molecular residual disease test to help identify patients with resectable colorectal cancer who are at an increased risk of recurrence and predict who are most likely to benefit from adjuvant chemotherapy. In a presentation at the 2023 European Society for Medical Oncology Congress in Madrid, Natera and its collaborators shared an expanded GALAXY analysis that builds on results published in January 2023 in Nature Medicine. With 2,625 CRC patients and disease free survival assessment at 24 months, this analysis includes more than twice the number of patients and significantly longer follow-up than the previously published 18-month findings. Key highlights include: Circulating tumor DNA negative patients continued to show exceptional DFS regardless of adjuvant chemotherapy treatment. No significant difference in DFS at 24 months was observed for ctDNA negative patients receiving ACT compared to those with no ACT. Lack of absolute risk reduction between the two groups further improves on the previously published analysis. The presence of post-surgical ctDNA was the most significant prognostic factor for disease recurrence and was predictive of chemotherapy benefit. ctDNA positive patients receiving ACT had significantly higher DFS at 24 months compared to those with no ACT. Patients with ctDNA positive results had significantly lower DFS at 24 months than ctDNA negative patients. In a multivariate analysis, ctDNA status continued to be the most prognostic factor for cancer recurrence. Early ctDNA dynamics were predictive of recurrence. Changes in ctDNA status at 3 months post-surgery were significantly associated with DFS at 24 months. Additional randomized, phase III studies designed to evaluate Signatera MRD-guided adjuvant strategies in CRC are also underway as part of the CIRCULATE-Japan platform. These include the randomized ALTAIR trial, which aims to establish the utility of ACT escalation as well as treatment on molecular recurrence in the MRD-positive population; and the VEGA trial, which is analyzing de-escalation of ACT in the MRD-negative population.