Natera Signatera™ Flies High: Completes Enrollment of Revolutionary Phase III ALTAIR Trial in Colorectal Cancer

Natera, Inc. (NASDAQ: NTRA), a pioneering leader in cell-free DNA testing, is proud to announce the completion of enrollment for its cutting-edge ALTAIR clinical trial. This randomized, double-blind study is evaluating the utility of Signatera 5M molecular residual disease test in patients with stage II-IV resectable colorectal cancer.

With the promise of tumor DNA-guided treatment escalation as an alternative to traditional or de-escalated therapies, ALTAIR is a part of CIRCULATE-Japan adaptive trial platform. Primary results are expected to be announced mid 2024.

The ALTAIR trial has achieved its objective of enrolling 240 ctDNA-positive participants who have undergone surgery two years prior, with no further evidence of disease. These individuals are then randomized to receive either a placebo or TAS-102 (trifluridine/tipiracil), an efficacious treatment widely used for metastatic colorectal cancer (CRC).

The main focus of this experimental investigation is to measure disease-free survival through the primary endpoint, while also keeping tabs on ctDNA clearance as a secondary measurement.

The CIRCULATE-Japan trial, led by Dr. Takayuki Yoshino of the National Cancer Center Hospital East, aims to prove the viability of Signatera as an adjunct or surveillance tool to improve outcomes in patients with detectable ctDNA before it is visible on imaging. Through randomized controlled studies such as ALTAIR, the potential of ctDNA testing as a means to inform treatment decisions in CRC can be further validated.

In January 2023, GALAXY unveiled results from analyzing over 7,200 plasma time points from more than 1,000 CRC patients in Nature Medicine, demonstrating Signatera’s effectiveness in detecting increased recurrence risk in stage II-IV resectable CRC patients and predicting who would benefit most from adjuvant chemotherapy.

In June of that same year, American Society of Clinical Oncology (ASCO)’s annual meeting reported similar findings from an expanded cohort of 2,000 participants encompassing more than 3,800 plasma time points. Following which, the enrollment to ALTAIR was completed, highlighting Signatera’s clinical utility in CRC.

We are delighted to be one step closer to a future of ctDNA-guided cancer care with the completion of enrollment for the ALTAIR clinical study. Our collaboration with CIRCULATE-Japan will further advance precision medicine and improve outcomes for patients with resectable CRC. The study data gathered from GALAXY will help support this initiative, and we’re thrilled to be a part of the journey to enhancing cancer care.

About Signatera

Signatera is a revolutionary ctDNA test that revolutionizes how cancer patients are treated and monitored. By creating a customized blood test tailored to fit the unique signature of clonal mutations found in an individual’s tumor, clinicians can detect and quantify any cancer left in the body, even down to a single tumor molecule!

This advanced test has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications, so cancer recurrence can be identified earlier and treatment decisions can be optimized.

About Natera

At Natera, our mission is to revolutionize personalized genetic testing. Our reliable and advanced cell-free DNA testing provides precise diagnostic insights, enabling healthier lives. Accredited by the Clinical Laboratory Improvement Amendments (CLIA) and with more than 150 peer reviewed publications to back our accuracy and precision, Natera’s ISO 13485-certified and CAP-accredited laboratories in Austin, Texas and San Carlos, California, are driving this revolution of health and wellness forward.

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