Benzinga | Nov 10, 2020 09:06AM EST

Natera Highlights Presentation Of New Data At 2020 SITC Annual Meeting Highlighting Applications Of Personalized ctDNA Testing In Immunotherapy Treatment Monitoring

SAN CARLOS, Calif., Nov. 10, 2020 /PRNewswire/ -- Natera, Inc. (NASDAQ:NTRA), a pioneer and global leader in cell-free DNA testing, today announced it will present new immunotherapy data on its personalized and tumor-informed molecular residual disease (MRD) assay, Signatera, at the Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting, taking place November 9-14, 2020.

Natera will present four posters demonstrating the ability of Signatera to monitor response to immunotherapy in colorectal and breast cancer.

"Tumor-informed circulating tumor DNA tests have broad clinical utility across cancer types," said Georges Azzi, MD, oncologist at Holy Cross Health in Ft. Lauderdale, Florida and co-author of one of the posters presented. "I am excited to partner with Natera to further explore early indications of treatment response, or lack thereof, using this novel technology."

"We have consistently demonstrated the clinical utility of MRD testing with Signatera to help patients detect recurrence earlier, and we are now seeing evidence of Signatera's ability to effectively monitor immunotherapy treatment," said Alexey Aleshin, MD, Natera's Senior Medical Director of Oncology. "The studies we are presenting at SITC showcase Signatera's broadened capability to evaluate immunotherapy treatment response, an area in which there is a significant unmet need for more optimal diagnostic tools."

Details about the abstracts are as follows:

Abstract #23 | Poster Presentation

Presenter: Pashtoon Kasi, MD, MS

Circulating tumor DNA (ctDNA) serial analysis during progression on PD-1 blockade and later CTLA-4 rescue in patients with mismatch repair deficient metastatic colorectal cancer

A case series of three patients with mismatch repair deficient (dMMR), high microsatellite instability metastatic colorectal cancer (CRC), who progressed on PD-1 inhibitor pembrolizumab and were being treated with CTLA-4 inhibitors (nivolumab and ipilimumab). All patients were monitored with radiological imaging and serial ctDNA assessments using Signatera. ctDNA levels were corroborated by imaging in all cases and predicted tumor responses weeks ahead of imaging, supporting the use of ctDNA as a dynamic biomarker for response to immunotherapy.

Abstract #24 | Poster Presentation

Presenter: Pashtoon Kasi, MD, MS

Utility of tumor-informed molecular residual disease assays in patients with complete response to immune checkpoint blockade

Data regarding neoadjuvant usage of immunotherapy pertaining to mismatch repair deficient tumors is limited to-date. This poster describes two patients with advanced, non-metastatic dMMR tumors undergoing immune checkpoint blockade (ICB) therapy. Both patients achieved robust and dramatic responses to ICB therapy, with complete clearance of ctDNA and no evidence of residual disease radiologically, supporting the clinical decision to defer surgery and radiation. These data highlight a potential use of ctDNA-based MRD testing to help inform "watch & wait" approaches.

Abstract #25 | Poster Presentation

Presenter: Georges Azzi, MD

Line of therapy adjustment in a patient with advanced triple-negative breast cancer (TNBC) by using personalized ctDNA test for treatment response monitoring

A case study of a patient with advanced TNBC whose clinical course was tracked using ctDNA and radiologic imaging. After surgery, the patient tested positive for MRD using Signatera, but negative when assessed using a tumor-naive assay. Serial ctDNA analysis over the course of the patient's treatment enabled detection of lack of response and acquired resistance to therapy as much as 80 days earlier compared to imaging.

Abstract #26 | Poster Presentation

Presenter: Charles J. Schneider, MD, FACP

ctDNA clearance and radiographic resolution of lymph node metastasis in a patient with metastatic microsatellite stable colorectal cancer on immunotherapy

A case study of a patient with metastatic CRC with high tumor mutational burden (TMB) and CEA-low phenotype. The patient was MRD positive following initial surgical resection of the metastatic lesion, with ctDNA continuing to rise as a result of lymph node involvement. Upon receiving two rounds of immunotherapy, the patient showed complete clearance of ctDNA, correlating with radiologic resolution of metastatic disease. This suggests that ctDNA can serve as a dynamic biomarker of disease status, which may be more useful for monitoring treatment response, regardless of CEA expression.