Signatera | Tumor Types | Natera

Detect residual disease before it spreads

Introducing the first ctDNA surveillance tool – the sooner you know, the sooner you can act

Detect residual disease before it spreads

Introducing the first ctDNA surveillance tool – the sooner you know, the sooner you can act

Detect residual disease before it spreads

Introducing the first ctDNA surveillance tool – the sooner you know, the sooner you can act

Detect residual disease before it spreads

Introducing the first ctDNA surveillance tool – the sooner you know, the sooner you can act

What tumor types has Signatera been studied in?

Signatera is designed to be applied across all solid tumors for treatment monitoring and MRD assessment. Tumor types in which data has been generated include lung, bladder, colorectal, and breast.1-4 We have a number of ongoing studies, as well as plans for future prospective clinical studies.

 

Lung

Colorectal

Bladder

Breast

Ongoing studies

 

Lung

Featured on the cover of Nature

An early version of the Signatera technology was studied in the Cancer Research UK-funded TRACERx (Tracking Cancer Evolution Through Therapy [Rx]) Study. In patients with early-stage non-small cell lung cancer, the Signatera technology detected residual disease after adjuvant therapy, and predicted post-surgical recurrence, with an average lead time of 4 months (median = 70 days, maximum of 347 days).1

 

 

 

 

Colorectal

Presented at the ESMO 2018 Congress

Signatera was studied in a cohort of 130 patients with colorectal cancer, stages I through IV. Patients were treated with curative surgery and optional adjuvant chemotherapy, and plasma samples were longitudinally collected. A total of 829 blood time points were assessed, with a median follow-up of 12.4 months.2

The presence or absence of ctDNA was associated with high or low post-surgical recurrence risk, respectively, in patients with colorectal cancer. This association was observed both prior to and after adjuvant chemotherapy. Molecular relapse was detected at a median lead time of 10.1 months (maximum of 16.5 months) before recurrence was detected by radiography.2

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Bladder

Presented at the ESMO 2018 Congress

Signatera was used in a prospective study that included 68 patients with locally advanced muscle-invasive bladder cancer (MIBC) who were scheduled for chemotherapy. Prior to cystectomy, all patients were treated with neoadjuvant or first-line chemotherapy before cystectomy. Patients had up to 2 years of follow-up, including longitudinal collection of plasma samples. A total of 618 blood time points were assessed, with a median follow-up of 434 days.3

Presence of ctDNA at diagnosis and post-cystectomy were associated with significantly lower relapse-free survival (RFS). Molecular relapse was detected at a median lead time of 3.6 months (maximum of 245 days) before recurrence was detected by radiography.3

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Breast

Presented at the 2018 San Antonio Breast Cancer Symposium

 

Early detection of residual breast cancer

Signatera was studied in a cohort of 49 women diagnosed with non-metastatic breast cancer with high risk of recurrence. All patients completed adjuvant chemotherapy within 3 years of entering the study. A total of 208 longitudinal blood time points were assessed.4

Molecular relapse of ctDNA in the plasma was detected in 89% (16/18) of relapse patients at a median lead time of 8.9 months (maximum of 2 years) before clinical or radiological relapse. Presence of absence of plasma ctDNA at the first post-surgical time point or at any longitudinal time point was associated with high or low recurrence risk, respectively.4  

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Response to neoadjuvant therapy in I-SPY 2 Trial

Signatera was studied in a cohort of 90 high risk stage II and III breast cancer patients treated in the I-SPY2 trial’s MK-2206 and control arms. Patients were treated with neoadjuvant therapy and curative surgery, and plasma samples were longitudinally collected. The presence or absence of ctDNA was associated with increased tumor burden, more aggressive tumor biology, and more aggressive subtypes. Trends in ctDNA levels during neoadjuvant therapy reflected changes in tumor responses. Early clearance of ctDNA5 predicted response to neoadjuvant therapy, and the presence of ctDNA after neoadjuvant therapy is significantly associated with poor distant recurrence-free survival.

Click here to download poster

Ongoing and Planned Studies

Collaborators Tumor type Study goal Patients studied
Institut Jules Bordet Correlate results of ctDNA with clinical outcomes, including pathological response and event- free survival Non-metastatic, post-neoadjuvant therapy and post-surgery
Fox Chase Cancer Center Determine relationship between kidney cancer genetic profiles and prognosis with ctDNA Patients with kidney cancer who recurred or did not recur after ≥3 years
Neon Therapeutics Use of ctDNA to assess treatment response to the NEO-PV-01 personal cancer vaccine in combination with pembrolizumab and a chemotherapy regimen of pemetrexed and carboplatin in the NT-002 trial Untreated patients with advanced or metastatic non-squamous non-small cell lung cancer

Ongoing and Planned Studies

Collaborators Tumor type Study goal Patients studied
Institut Jules Bordet Correlate results of ctDNA with clinical outcomes, including pathological response and event- free survival Non-metastatic, post-neoadjuvant therapy and post-surgery
Fox Chase Cancer Center Determine relationship between kidney cancer genetic profiles and prognosis with ctDNA Patients with kidney cancer who recurred or did not recur after ≥3 years
Neon Therapeutics Use of ctDNA to assess treatment response to the NEO-PV-01 personal cancer vaccine in combination with pembrolizumab and a chemotherapy regimen of pemetrexed and carboplatin in the NT-002 trial Untreated patients with advanced or metastatic non-squamous non-small cell lung cancer

Ongoing and Planned Studies

Collaborators Tumor type Study goal Patients studied
Institut Jules Bordet Correlate results of ctDNA with clinical outcomes, including pathological response and event- free survival Non-metastatic, post-neoadjuvant therapy and post-surgery
Fox Chase Cancer Center Determine relationship between kidney cancer genetic profiles and prognosis with ctDNA Patients with kidney cancer who recurred or did not recur after ≥3 years
Neon Therapeutics Use of ctDNA to assess treatment response to the NEO-PV-01 personal cancer vaccine in combination with pembrolizumab and a chemotherapy regimen of pemetrexed and carboplatin in the NT-002 trial Untreated patients with advanced or metastatic non-squamous non-small cell lung cancer

Ongoing and Planned Studies

Collaborators Tumor type Study goal Patients studied
Institut Jules Bordet Correlate results of ctDNA with clinical outcomes, including pathological response and event- free survival Non-metastatic, post-neoadjuvant therapy and post-surgery
Fox Chase Cancer Center Determine relationship between kidney cancer genetic profiles and prognosis with ctDNA Patients with kidney cancer who recurred or did not recur after ≥3 years
Neon Therapeutics Use of ctDNA to assess treatment response to the NEO-PV-01 personal cancer vaccine in combination with pembrolizumab and a chemotherapy regimen of pemetrexed and carboplatin in the NT-002 trial Untreated patients with advanced or metastatic non-squamous non-small cell lung cancer

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References

  1. Corcoran RB, Chabner BA. Application of cell-free DNA analysis to cancer treatment. N Engl J Med. 2018;379(18):1754-1765.
  2. Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451.
  3. Reinert T, Henriksen TV, Christensen E, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer [published online ahead of print May 9, 2019]. JAMA Oncol. 2019. doi:10.1001/jamaoncol.2019.0528.
  4. Christensen E, Birkenkamp-Demtröder K, Sethi H, et al. Early detection of metastatic relapse and monitoring of therapeutic efficacy by ultra-deep sequencing of plasma cell-free DNA in patients with urothelial bladder carcinoma [published online ahead of print May 6, 2019]. J Clin Oncol. 2019. doi:10.1200/JCO.18.02052.
  5. Coombes RC, Page K, Salari R, et al. Personalized detection of circulating tumor DNA antedates breast cancer metastatic recurrence [published online ahead of print April 16, 2019]. Clin Cancer Res. 2019. doi:10.1158/1078-0432.CCR-18-3663.
  6. Sethi H, Salari R, Navarro S, et al. Analytical validation of the Signatera™ RUO assay, a highly sensitive patient-specific multiplex PCR NGS-based noninvasive cancer recurrence detection and therapy monitoring assay. Poster presented at: American Association for Cancer Research (AACR) Annual Meeting; April 17, 2018; Chicago, IL. Abstract 4542.
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