
Natera Study Demonstrates Ability of Signatera To Guide Clinical Decision Making in Unresectable NSCLC Patients
Natera, a global leader in cell-free DNA testing, has announced a new study published in Frontiers in Oncology that underscores the capabilities of their molecular residual disease (MRD) test, Signatera for early progression detection, risk stratification, and the ability to monitor unresectable stage I-III non-small cell lung cancer (NSCLC) patients who received definitive radiotherapy.
Lung cancer is a widespread diagnosis globally, with approximately 240,000 new cases in the U.S. every year. NSCLC accounts for 81% of all lung cancer cases in the U.S. every year. While early-stage NSCLC patients often undergo curative-intent radiotherapy, approximately 46% of them still experience disease progression despite treatment. Accurate risk assessment is and disease progression assessment is essential to determine the necessity of additional therapy after radiotherapy.
The study involved analyzing circulating tumor DNA (ctDNA) status in patients with unresectable stage I-III NSCLC who received nonsurgical treatment. In the United States, approximately 36% of early-stage non-small cell lung cancer (NSCLC) patients are considered inoperable and are primarily managed with curative-intent radiotherapy, with or without chemotherapy. Over 70 plasma samples from 17 NSCLC patients were monitored before, during, and after conventional radiation therapy, with or without concurrent systemic therapy and adjuvant durvalumab, for a median period of 26 months.
The study found an 82% pre-treatment ctDNA detection rate, varying based on histology and stage. Signatera demonstrated 100% sensitivity in identifying patients with clinical progression, all of whom had ctDNA-positive results. The test also demonstrated 100% specificity in identifying progression-free patients who remained ctDNA-negative after radiation treatment. The average lead time was 5.4 months for ctDNA detection ahead of clinical progression. The study also found that ctDNA status after radiation therapy and during adjuvant systemic therapy and/or surveillance was highly predictive of disease progression and in multivariate analysis, ctDNA detection post-radiation was the only significant factor associated with progression-free survival.
Dr. Minetta Liu, Chief Medical Officer of Oncology at Natera, emphasized that this study demonstrates the potential of Signatera to offer customized treatment strategies for unresectable NSCLC patients by predicting disease progression with high sensitivity and specificity. These findings add to the growing body of evidence supporting Signatera’s role in improving care for NSCLC patients.