On November 5, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported it will present important new Signatera data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, taking place November 4–8 in Phoenix, Arizona.
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Immune checkpoint inhibitors (ICIs) have transformed treatment for many metastatic cancers, and some patients achieve durable disease control.1 However, it remains challenging for clinicians to determine how long to continue therapy, since imaging alone is prone to error and cannot show whether disease has cleared at the molecular level.2,3 As a result, treatment duration remains an open question, particularly for patients who achieve a durable clinical response.
A real-world analysis at SITC (Free SITC Whitepaper) studied outcomes of 424 patients treated with first-line immunotherapy across stage IV melanoma, renal cell carcinoma, microsatellite instability-high (MSI-H) colorectal cancer (CRC), and non-small cell lung cancer (NSCLC). The Signatera test was used to identify complete molecular responders (CMRs), defined as patients with two consecutive negative results. Findings showed:
Improved survival in Signatera MRD-negative patients: CMRs had a 36-month overall survival (OS) of 93.2% vs. 77.9% in all other patients (HR 0.24; P=0.0003).
Favorable survival across tumor types: At 36 months, OS in CMRs ranged from 83.1% (NSCLC) to 100% (MSI-H CRC).
No significant survival difference with early ICI discontinuation: OS for CMRs who remained on IO was 93.5% vs. those who stopped (89.4%) (P=0.42).
"For patients with metastatic cancer who achieve a durable response, deciding how long to continue immunotherapy is one of the most difficult clinical decisions," said Meghan J. Mooradian, MD, Cutaneous Medical Oncology, Mass General Brigham Cancer Institute, and lead author of the study. "Because imaging alone may not fully capture whether disease has been completely cleared, our findings support further investigation of molecular response as a biomarker to help personalize treatment duration and identify patients who may discontinue therapy early."
"Melanoma, kidney, lung, and colorectal cancers differ biologically, yet sustained Signatera negativity was associated with favorable survival in each," said Alexey Aleshin, MD, Corporate Chief Medical Officer and General Manager, Oncology, Natera. "These data support the role of Signatera in identifying exceptional ICI responders who may be able to de-escalate treatment."
References
Wolchok JD, et al. Final, 10-Year Outcomes with Nivolumab plus Ipilimumab in Advanced Melanoma. N Engl J Med 2025;392:11-22.
Steimle AK, et al. Circulating Tumor DNA (ctDNA) Clearance After Immune Checkpoint Inhibition (ICI) with Radiotherapy (RT) as a Prognostic Biomarker for Advanced Melanoma. Cancers 2026;18(18):3032.
Anagnostou V, et al. Immuno-oncology trial endpoints: Capturing clinically meaningful activity. Clin Cancer Res 2017;23(17):4959-69.
(Press release, Natera, NOV 5, 2026, View Source [SID1234674361])