Know earlier if ICI treatment is working
During treatment with immune-checkpoint inhibitors (ICI), you want answers to critical questions as soon as possible.
- Is the treatment working?
- Is the tumor truly progressing?
- Should you change or restart treatment?
Signatera is a personalized tumor-informed assay for ultrasensitive detection of molecular residual disease (MRD) using circulating tumor DNA (ctDNA) to assess treatment response in conjunction with standard imaging.
Signatera is covered by Medicare for immunotherapy treatment response monitoring across all tumor types and stages of cancer.
The challenges of ICI treatment.
The power of ctDNA.
Despite dramatic improvements in cancer care using antibodies that block the immune checkpoint proteins CTLA-4, PD-1, or PD-L1, the reality is ICI-based treatments don’t work for everyone:
- About 43.5% of cancer patients are eligible for ICI treatment.1,2
- Less than 20% of eligible patients will derive sustained response or clinical benefit to ICIs.1,2
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.
Hear how Signatera helped guide Jeffrey’s treatment plan
INSPIRE Trial: Validating ctDNA as an early biomarker of ICI treatment response
Signatera was evaluated in the INSPIRE trial, a randomized, prospective study in patients with advanced or metastatic solid malignancies receiving an anti-PD-1 therapy.7
- 98% of patients had detectable ctDNA at baseline
- An increase in ctDNA levels from baseline at week 6 strongly predicted disease progression and non-response to an anti-PD-1 therapy
- Achieving ctDNA clearance at any time during treatment correlated with durable OS
Overall survival was 100% in patients who experienced ctDNA clearance for at least one on-treatment time point
BESPOKE study of ctDNA guided immunotherapy (IO)
The BESPOKE IO clinical study is currently enrolling patients living with colorectal cancer, non-small cell lung cancer, and melanoma who will receive standard of care ICIs. The study will determine how routine Signatera testing impacts treatment decisions and early detection of disease progression when integrated as part of routine assessment of tumor response.
Natera and its collaborators will collect clinical utility and outcome data for two years from patient enrollment. This data will help better understand how Signatera ctDNA test results correlate to responses to ICIs and how Signatera can help physicians and patients in treatment planning.
Questions about Signatera? Submit your inquiries here.
1Haslam A, Prasad V. JAMA Network Open. 2019;2(5):e192535-e192535.
2Haslam A, Gill J, Prasad V. JAMA Netw Open. 2020;3(3):e200423. doi:10.1001/jamanetworkopen.2020.0423
3Reinert T, Henriksen TV, Christensen E, et al. JAMA Oncology. 2019;5(8):1124-1131.
4Coombes C, Page K, Salari R, et al. Clinical Cancer Research. 2019;25(14):4255-4263.
5Abbosh C, Birkbak N, Wilson GA, et al. Nature. 2017,545:446–451
6Christensen E, Birkenkamp-Demtröder K, Sethi H, et al. 2019; 37(18):1547-1557.
7Bratman SV, Yang SYC, Iafolla MAJ, et al. Nat Cancer. 2020;1:873–881.