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Discover a smarter way to manage ICI treatment

Each patient has the power to advance medicine. Now, your patients can help conquer the next frontier in immuno-oncology (IO) cancer management while discovering more answers about their own immune-checkpoint inhibitor (ICI) treatment response. Our clinical study, BESPOKE IO, is currently enrolling cancer patients initiating ICI. By participating, those living with colorectal cancer, non-small cell lung cancer, or melanoma can help the medical community more deeply understand these diseases.

The challenges of ICI treatment.
The power of ctDNA.

Despite dramatic improvements in cancer patient care using ICI-based treatment, the reality is it doesn’t work for everyone.

  • About 43.5% of cancer patients are eligible for ICI treatment1,2
  • Less than 20% of eligible patients derive sustained response or clinical benefit to ICIs1,2

Early and ultrasensitive monitoring of tumor progression is key to improving patient outcomes in the immuno-oncology (IO) setting. Existing methods, including CT scans and serum protein biomarkers, are unreliable in this regard.

Signatera enables highly sensitive cancer monitoring by tracking the patient’s unique tumor mutational signature in circulating tumor DNA (ctDNA). This tumor-informed approach also makes it possible to evaluate IO treatment response much earlier than CT scans and serum protein biomarkers.

Bring BESPOKE IO to your institution

Adopt Signatera into your practice and contribute insights to the community. The BESPOKE IO clinical study will examine participant data and blood samples to determine the effects on clinical outcomes when Signatera is integrated into the management of ICI cancer treatment. Signatera Molecular Residual Disease (MRD) Test is a personalized surveillance liquid biopsy-based test that is customized to each patient’s unique set of tumor mutations.

Natera and its collaborators will collect clinical utility and outcome data on enrolled patients for two years. This data will help the immuno-oncology (IO) community better understand how patients respond to ICIs and what they should do next.

Qualify patients for BESPOKE IO

  • Living with colorectal cancer, non-small cell lung cancer or melanoma
  • Clinically eligible and plan to receive an antineoplastic agent that works by immune checkpoint blockade, such as anti-PD-1, anti-CTLA-4 or anti-PD-L1
  • Able to tolerate blood draws from the arm
  • 18 years of age or older
  • Able to provide written consent

The BESPOKE IO clinical study will assess the Signatera MRD test for impact on treatment decisions on tumor assessment timepoints after immunotherapy initiation.

Know how Signatera works: a personalized and tumor-informed approach to MRD surveillance

Personalized, tumor-informed assay

One-time, primary tissue sample and matched normal tissue is required for whole exome sequencing and personalized test design.

Ultrasensitive ctDNA detection

Signatera detects ctDNA of somatic and truncal variants to optimize sensitivity. Tumor-informed method enables filtering of CHIP mutations to decrease false positive rates.

Optimized for longitudinal monitoring

Once the patient’s personalized test has been designed, only a blood sample is needed each subsequent time Signatera is ordered.

Expect safety and simplicity with BESPOKE IO

  • Work with your patient and Natera to schedule blood draws in clinic or at home
  • Complete questionnaires throughout two years of study
  • Work with your patients to use Signatera test reports to help guide care plans

Read more about BESPOKE IO on clinicaltrials.gov

Questions about bringing BESPOKE IO to your clinic? Submit your inquiries here.



References

1Haslam A, Gill J, Prasad V. Estimation of the Percentage of US Patients With Cancer Who Are Eligible for Immune Checkpoint Inhibitor Drugs. JAMA Netw Open. 2020;3(3):e200423. doi:10.1001/jamanetworkopen.2020.0423

2Haslam A, Prasad V. Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs. JAMA Network Open. 2019;2(5):e192535-e192535.