Signatera | Applications | Natera

Tumor Types

Tumor Types

Tumor Types

Tumor Types

What tumor types has Signatera (RUO)
been studied in?

Signatera RUO 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 (RUO) 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 (RUO) 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 2018 AACR Annual Meeting

Signatera (RUO) 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 12.3 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. From a single Signatera (RUO) result immediately following surgery, relapse-free survival (RFS) at 3 years was 25% for ctDNA positive and 89% for ctDNA negative patients.2 Molecular relapse was detected at a median lead time of 7.9 months (maximum of 11.9 months) before recurrence was detected by radiography.

Click here to download poster

 

 

 

Bladder

Presented at the 2018 AACR Annual Meeting

Signatera (RUO) was used in a prospective study that included 50 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 386 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). From a single Signatera (RUO) result at the time of diagnosis, RFS at 2 years was 20% for ctDNA-positive and 100% for ctDNA-negative patients. Molecular relapse was detected at a median lead time of ~4 months (maximum of 265 days) before recurrence was detected by radiography.3

Click here to download poster

 

 

Breast

In collaborations with UCSF, Quantum Leap Healthcare Collaborative, Imperial College London, University of Leceister, and Institut Jules Bordet, Signatera (RUO) ctDNA assay is being used to monitor tumor burden, molecular response after treatment, and minimal residual disease in women with early stage breast cancer. Results from these studies will be presented at future conferences.

Areas of investigation in breast cancer:

  • Use of ctDNA in monitoring tumor burden, treatment response, and residual disease, as compared to traditional imaging methods in women who received investigational therapies combined with neoadjuvant treatment click here
  • Use of ctDNA as a biomarker for prediction of disease progression before scans in women with breast cancer after surgery and adjuvant therapy click here
  • Use of ctDNA to evaluate molecular response and minimal residual disease (MRD) in women with early stage breast cancer after neoadjuvant therapy followed by surgery click here

 

Ongoing and Planned Studies

Collaborators Tumor type Study goal Patients studied
UCSF and Quantum Leap Healthcare Collaborative Use of ctDNA in monitoring tumor burden, treatment response, and residual disease compared to traditional imaging methods in the I-SPY2 trial Newly diagnosed, locally advanced breast cancer
Imperial College London and University of Leicester Explore ctDNA as a biomarker to predict disease progression before scans Non-metastatic, post-surgery and post-adjuvant therapy
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
Bristol-Myers Squibb Phase II, prospective trial to select patients with minimal residual disease (MRD) after surgery to receive adjuvant standard of care with or without nivolumab Non-metastatic non-small cell lung cancer patients after surgical resection
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
UCSF and Quantum Leap Healthcare Collaborative Use of ctDNA in monitoring tumor burden, treatment response, and residual disease compared to traditional imaging methods in the I-SPY2 trial Newly diagnosed, locally advanced breast cancer
Imperial College London and University of Leicester Explore ctDNA as a biomarker to predict disease progression before scans Non-metastatic, post-surgery and post-adjuvant therapy
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
Bristol-Myers Squibb Phase II, prospective trial to select patients with minimal residual disease (MRD) after surgery to receive adjuvant standard of care with or without nivolumab Non-metastatic non-small cell lung cancer patients after surgical resection
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
UCSF and Quantum Leap Healthcare Collaborative Use of ctDNA in monitoring tumor burden, treatment response, and residual disease compared to traditional imaging methods in the I-SPY2 trial Newly diagnosed, locally advanced breast cancer
Imperial College London and University of Leicester Explore ctDNA as a biomarker to predict disease progression before scans Non-metastatic, post-surgery and post-adjuvant therapy
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
Bristol-Myers Squibb Phase II, prospective trial to select patients with minimal residual disease (MRD) after surgery to receive adjuvant standard of care with or without nivolumab Non-metastatic non-small cell lung cancer patients after surgical resection
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
UCSF and Quantum Leap Healthcare Collaborative Use of ctDNA in monitoring tumor burden, treatment response, and residual disease compared to traditional imaging methods in the I-SPY2 trial Newly diagnosed, locally advanced breast cancer
Imperial College London and University of Leicester Explore ctDNA as a biomarker to predict disease progression before scans Non-metastatic, post-surgery and post-adjuvant therapy
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
Bristol-Myers Squibb Phase II, prospective trial to select patients with minimal residual disease (MRD) after surgery to receive adjuvant standard of care with or without nivolumab Non-metastatic non-small cell lung cancer patients after surgical resection
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. Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451.
  2. Reinert T, Henriksen TV, Rasmussen MH, et al. Personalized circulating tumor DNA analysis to monitor colorectal cancer. Poster presented at: American Association for Cancer Research Annual Meeting; April 17, 2018; Chicago, IL. Abstract 1590.
  3. Birkenkamp-Demtröder K, Christensen E, Sharma S, et al. Sequencing of plasma cfDNA from patients with locally advanced bladder cancer for surveillance and therapeutic efficacy monitoring. Poster presented at: American Association for Cancer Research Annual Meeting; April 17, 2018; Chicago, IL. Abstract 3653.
  4. Natera, data on file
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