Natera has reported the latest data from the Phase III CALGB (Alliance)/SWOG 80702 study, indicating that Signatera, a molecular residual disease test could be instrumental in improving treatment outcomes for colorectal cancer patients.

This study assessed whether subjects with detectable molecular residual disease post-surgery could benefit from an escalated adjuvant treatment regimen.

The trial utilised Signatera to determine the benefits of adding celecoxib to the standard of care adjuvant chemotherapy with FOLFOX for stage III colorectal cancer management.

Nearly 1,000 subjects with post-surgical plasma samples were involved in pre-specified analysis and received FOLFOX with or without celecoxib.

The study’s key findings demonstrated that subjects who were Signatera-positive after surgery had a significant disease-free survival (DFS) and overall survival (OS) benefit when celecoxib was added to their adjuvant FOLFOX therapy.

Specifically, the addition of celecoxib significantly improved DFS in comparison to placebo, with a three-year DFS of 44.1% versus 26.6%. The OS results mirrored this benefit.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Enter your work email
First Name
Last Name
Company Name
Job title *
Phone number *
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Conversely, no survival advantage was observed for Signatera-negative subjects when celecoxib was added to their chemotherapy regimen.

Moreover, the test status post-surgery was highly predictive of cancer recurrence, with positivity being significantly associated with worse DFS and OS outcomes.

Natera oncology general manager and corporate chief medical officer Alexey Aleshin said: “The results from the CALGB (Alliance)/SWOG 80702 study mark an unprecedented moment in personalised medicine for patients with colorectal cancer.

“We demonstrated Signatera’s ability to predict a benefit in both disease-free survival and overall survival for Signatera-positive patients from the addition of celecoxib, an extremely accessible, affordable and well-tolerated therapy.”

Signatera leverages circulating tumour DNA for identifying and quantifying residual cancer, enabling earlier recurrence detection.

The test is used for several malignancies including breast, muscle-invasive bladder, ovarian and colorectal cancer. It has been clinically validated across various cancer types.

Last month, the company commenced enrolment in the Phase III SAGITTARIUS trial, aiming to evaluate the Signatera test in personalising adjuvant treatment strategies for stage III and high-risk stage II colon cancer subjects after surgical resection.