Test performance showed 82% pre-treatment detection, with 100% longitudinal sensitivity and 100% longitudinal specificity to disease progression
AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced a new study published in Frontiers in Oncology demonstrating the ability of Natera’s personalized and tumor-informed molecular residual disease (MRD) test, Signatera™, to detect progression early, with high sensitivity and specificity, and risk stratify patients with unresectable stage I-III non-small cell lung cancer (NSCLC) treated with definitive radiotherapy. The full study can be found here.
Worldwide, lung cancer is the second most commonly diagnosed cancer. NSCLC is the most common type of lung cancer in the U.S., accounting for 81% of all lung cancer diagnoses.1 For early-stage NSCLC patients, 36% are inoperable and primarily managed with curative-intent radiotherapy, with or without chemotherapy;2 however, despite the treatment, 46% of patients still experience disease progression.3,4 Accurate risk assessment can identify patients who might derive benefit from additional treatment after radiotherapy, versus patients with more favorable outcomes who could be spared the unnecessary treatment toxicity. In addition, there is a need for sensitive and specific biomarkers to support early detection of progression before the onset of disease-related symptoms, at a time when therapy might provide greater clinical benefit.
This prospective study investigated the association of circulating tumor DNA (ctDNA) status with progression in patients with unresectable stage I-III NSCLC who underwent definitive nonsurgical treatment. A total of 70 serial plasma samples from 17 NSCLC patients were monitored before, during, and after conventional radiation with or without concurrent systemic therapy and adjuvant durvalumab for a median of 26 months.
Key findings include:
- Pre-treatment ctDNA detection rate was 82% (14/17) and varied based on histology and stage.
- In the longitudinal setting, all patients with clinical progression had at least one ctDNA-positive result (9/9; 100% sensitivity), and all progression-free patients were persistently ctDNA-negative after completing radiation with or without chemotherapy (8/8; 100% specificity).
- ctDNA detection demonstrated an average lead time of 5.4 months over clinical progression.
- ctDNA status after radiotherapy (single time point: HR=24.2; p=0.004), as well as during adjuvant systemic therapy and/or surveillance (longitudinally; p50%) PD-L1 Expression, Randomized to Cemiplimab vs Chemotherapy. Presented at ASCO Annual Meeting, Chicago, IL, June 2023.
- Early Real-World Experience Monitoring Circulating Tumor DNA in Resected Early-Stage Non-Small Cell Lung Cancer. Presented at AATS Annual Meeting, LA, CA, May 2023.
- Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451.
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Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com
Source: Natera, Inc.