Natera | MedPath

Signatera ctDNA Test Predicts Recurrence Risk in High-Risk Breast Cancer Patients, I-SPY 2 Trial Data Shows

14 days ago

• Natera's Signatera test demonstrated that patients with detectable circulating tumor DNA at diagnosis had three times higher risk of recurrence in early-stage, high-risk breast cancer, according to I-SPY 2 trial data to be presented at ESMO Breast Annual Congress. • The study of 712 patients revealed that pre-treatment ctDNA quantity significantly correlates with clinical outcomes in breast cancer, with Signatera status emerging as the most significant predictor of distant recurrence-free survival regardless of disease subtype. • Researchers suggest these findings could lead to new treatment protocols, potentially allowing Signatera-negative patients to avoid chemotherapy or other intensive treatments, representing a significant advancement in personalized breast cancer care.

Natera's Prospera Heart Test with DQS Shows Superior Performance in Detecting Transplant Rejection

15 days ago

• New study published in the American Journal of Transplantation demonstrates Prospera Heart with DQS significantly outperforms traditional dd-cfDNA percentage tests, with sensitivity increasing from 78.2% to 86.5%. • The innovative two-threshold algorithm combines donor fraction and donor quantity score, reducing false positives by over 37% and potentially decreasing the need for invasive endomyocardial biopsies. • Research involving 808 test samples from 187 heart transplant patients shows improved specificity (83.6% vs 76.9%) and area under the curve (0.881 vs 0.865) compared to conventional methods.

Natera Launches HEROES Trial to Explore Treatment De-escalation in HER2+ Metastatic Breast Cancer

2 months ago

• Natera has enrolled the first patients in the HEROES phase II clinical trial, investigating the potential to safely discontinue anti-HER2 therapy in metastatic breast cancer patients with no detectable circulating tumor DNA. • The trial will use Natera's Signatera test to identify patients who may safely stop maintenance therapy, potentially freeing them from lifelong treatment regimens that can be costly and cause adverse effects. • Approximately 170 patients across 35 French sites will participate in the study, which could fundamentally change treatment approaches for the 15-20% of breast cancer patients with HER2-positive tumors.

Natera's Signatera Shows Promise in Colorectal Cancer MRD Detection and Early Detection

4 months ago

• Natera's Signatera test demonstrates strong prognostic and predictive capabilities in colorectal cancer (CRC) patients, particularly in identifying minimal residual disease (MRD). • The BESPOKE CRC study reveals that post-surgical Signatera positivity is associated with inferior outcomes in stage II and III CRC patients, with significant differences in disease-free survival. • A novel tissue-free MRD detection test from Natera shows high sensitivity and specificity, indicating its potential as a non-invasive method for MRD assessment. • Data from the CIRCULATE and PROCEED-CRC studies highlight Signatera's effectiveness in early colorectal cancer detection, achieving high sensitivity and specificity rates.

Phase 1 Trial Shows Promise for Personalized T Cell Therapy in Advanced Melanoma

5 months ago

A first-in-human phase 1 trial evaluated BNT221, a personalized neoantigen-specific T cell therapy, in patients with advanced melanoma who progressed after standard treatments. The study demonstrated the feasibility and safety of manufacturing patient-specific T cell products targeting multiple tumor mutations, while providing early evidence of clinical activity.

ZEST Trial Halted Due to Low ctDNA Detection Rates in Early Breast Cancer

5 months ago

• The Phase III ZEST trial, evaluating niraparib for preventing breast cancer recurrence based on circulating tumor DNA (ctDNA), was terminated early due to low ctDNA detection rates. • Broad entry criteria in ZEST led to the inclusion of low-risk patients, resulting in a low rate of ctDNA positivity and hindering the trial's randomization process. • Exploratory analysis suggested a longer recurrence-free interval with niraparib in patients with low ctDNA levels at baseline, though the study was underpowered. • Future ctDNA-guided trials should focus on higher-risk patients and earlier ctDNA testing during neoadjuvant therapy to improve feasibility and outcomes.

Natera's Signatera Guides Personalized Treatment in Phase III Colon Cancer Trial

5 months ago

• Natera's SAGITTARIUS trial uses Signatera to personalize colon cancer treatment strategies, marking a shift from the one-size-fits-all approach. • The trial randomizes Signatera-positive patients to genotype-guided therapy or standard chemotherapy, exploring immunotherapy and targeted agents. • Signatera-negative patients in the study will receive physician's choice of treatment, including observation or single-agent capecitabine. • The SAGITTARIUS project, funded by the EU, involves 9 partners across Europe and 26 clinical centers, aiming for cost-effective, tailored treatments.

FDA Approves SpringWorks' Gomekli (Mirdametinib) for Neurofibromatosis Type 1

6 months ago

• The FDA has approved Gomekli (mirdametinib) for both adult and pediatric patients with Neurofibromatosis Type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. • Approval was based on Phase 2b ReNeu trial data, demonstrating a 41% ORR in adults and 52% in children, alongside deep and durable tumor volume reductions and manageable safety profiles. • Gomekli is the first and only medicine approved for both adults and children with NF1-PN, addressing a significant unmet need, particularly for adult patients who previously lacked approved treatments. • SpringWorks received a rare pediatric disease priority review voucher from the FDA, potentially expediting the review of future drug candidates.

ctDNA Testing Shows Promise in Guiding Colorectal Cancer Treatment Decisions

7 months ago

• ctDNA testing influenced adjuvant therapy decisions in 16.3% of stage II/III colorectal cancer cases, with de-escalation in 59.9% and escalation in 35.7%. • Post-operative ctDNA positivity predicts inferior disease-free survival, while ctDNA clearance is associated with superior outcomes in stage II/III CRC. • ctDNA testing demonstrates high sensitivity in detecting recurrence across various sites, including low-shedding areas like the peritoneum and lung. • Adjuvant chemotherapy benefit was evident only in MRD-positive patients, highlighting ctDNA's potential for treatment selection in stage II/III CRC.

ctDNA-Based Platform Aims to Accelerate Cancer Drug Development

8 months ago

• A new platform leverages circulating tumor DNA (ctDNA) to detect recurrence, potentially accelerating cancer drug development and reducing costs. • ctDNA monitoring can identify molecular evidence of disease recurrence earlier than traditional methods, allowing for earlier therapeutic intervention. • The platform aims to improve the efficiency of clinical trials by enriching for patients with molecular residual disease (MRD). • The FDA supports the use of ctDNA in early-stage solid tumor drug development, highlighting the urgent need for MRD-based trials.

Pembrolizumab Plus Chemotherapy Improves Overall Survival in Early-Stage TNBC

8 months ago

• The KEYNOTE-522 trial demonstrated that perioperative pembrolizumab combined with chemotherapy significantly improved overall survival in patients with early-stage triple-negative breast cancer. • The study showed a 34% reduction in the risk of death with the pembrolizumab regimen compared to chemotherapy alone, marking a clinically meaningful improvement. • The 5-year overall survival rate was 86.6% in the pembrolizumab arm versus 81.7% in the placebo arm, highlighting the long-term benefits of this treatment approach. • These findings support neoadjuvant pembrolizumab with chemotherapy followed by adjuvant pembrolizumab as a new standard of care for high-risk, stage II or III TNBC.