Natera has completed the enrolment in the Phase 3 ALTAIR clinical trial of the Signatera molecular residual disease (MRD) test in patients with stage II-IV resectable colorectal cancer (CRC).
Signatera is said to be a custom-built circulating tumour DNA (ctDNA) test.
Natera, a US-based clinical genetic testing company, has designed the test to treat, monitor and assess molecular residual disease (MRD) in patients previously diagnosed with cancer.
ALTAIR is a randomised, double-blind circulating tumour DNA (ctDNA)-guided treatment escalation arm of the CIRCULATE-Japan adaptive trial.
The trial platform is intended to evaluate the clinical utility of the Signatera MRD test in CRC patients.
The CIRCULATE-Japan trial consists of the observational GALAXY study and the randomised Phase 3 VEGA trial for ctDNA-guided de-escalation therapy.
Natera anticipates releasing the first ALTAIR results in mid-2024.
The ALTAIR researchers have enrolled more than 240 patients who tested ctDNA-positive within two years of surgery but had no signs of illness on clinical or radiographic examinations.
In the trial, ctDNA-positive patients are randomly assigned to receive either a placebo or TAS-102 (trifluridine/tipiracil), frequently prescribed to people with metastatic CRC.
The study’s primary endpoint is defined as disease-free survival and ctDNA clearance is a secondary endpoint.
Natera oncology chief medical officer Minetta Liu said: “The completion of enrolment to ALTAIR marks a significant milestone that will build on recent data from the GALAXY study and bring us one step closer to a future of ctDNA-guided cancer care.
“We are proud to partner with our collaborators from CIRCULATE-Japan to accelerate precision medicine and transform care for patients with resectable CRC.”
The recent announcement by the clinical genetic testing company follows the publication of multiple new datasets highlighting the clinical efficacy of Signatera in CRC in 2023.
According to results of more than 1,000 patients from the GALAXY trial, published in January last year, the ctDNA test can identify patients with stage II-IV resectable CRC at an increased risk of recurrence and predict who will most likely benefit from adjuvant chemotherapy, Natera said.
