C2i Genomics Study Finds Circulating Tumor DNA Can Predict Treatment Outcomes in Patients with Locally Advanced Rectal Cancer Enrolled for Organ Preservation

C2i Genomics, a cancer intelligence company, has announced preliminary results from a collaborative study with Memorial Sloan Kettering Cancer Center (MSK) as part of the Organ Preservation for Rectal Adenocarcinoma (OPRA) trial. This collaboration aims to show that circulating tumor DNA (ctDNA) detected by C2i’s assay (C2inform) can be used as a prognostic biomarker, improve the assessment of response, and enhance detection of minimal residual disease in patients with locally advanced rectal cancer (LARC) treated with neoadjuvant therapy (NAT). In the present study, C2inform, a whole genome minimal residual disease (MRD) test, was evaluated in 31 patients from the OPRA trial to assess the ability to serve as a prognostic biomarker to guide the course of treatment toward either an organ-sparing watch-and-wait protocol or surgical resection. The C2inform test utilizes whole genome sequencing (WGS) to characterize the complete set of cancer alterations and then applies AI-driven pattern recognition to detect traces of cancer in patient plasma samples.

The OPRA trial demonstrated that total mesorectal excision (TME) can be deferred—with equivalent survival outcomes—for the nearly 50% of LARC patients that obtain a complete response following neoadjuvant therapy. This organ-sparing protocol provides a path for patients to avoid significant morbidities and associated impairment to quality of life resulting from surgery. A high proportion of patients develop tumor regrowth and earlier detection can expedite surgical intervention.

The present study represents a breakthrough in locally advanced rectal cancer treatment, highlighting the efficacy of circulating tumor DNA (ctDNA) for noninvasive monitoring of MRD and response to neoadjuvant therapy. The C2inform test identified ctDNA with 96% sensitivity in patient plasma samples taken at baseline, before neoadjuvant therapy (n=24/25). The tumor fraction (TF) levels detected at baseline separated responders from non-responders (median TF 6.2e-4 vs 1.4e-3). Tumor detection at follow-up was associated with a higher rate of recurrence (p=0.037) and tumor was detected at follow-up for all 5/5 patients who developed recurrence. Overall, TF dynamics showed clearance of ctDNA down to the non-detection level throughout treatment in patients with a complete response (CR), while non-responders exhibited non-decreasing and often increasing estimates of ctDNA burden. Detection of ctDNA at follow-up for all patients who recurred is indicative of potential clinical utility for treatment de-escalation in the context of organ preservation.

“At C2i Genomics, we recognize the urgent need for more effective cancer treatment options,” said Asaf Zviran, CEO and co-founder of C2i Genomics. “Surgery is still considered the mainstay of treatment for LARC. However, we hope with this advanced MRD monitoring and the introduction of immuno-oncology(IO) neoadjuvant treatments, invasive surgeries can be avoided, allowing us to tailor treatment plans based on a patient’s unique clinical measurements.”

Expanding on these results, C2i has also partnered with the Spier Family Foundation and Massachusetts General Hospital (MGH) to evaluate ctDNA monitoring in the context of rectal cancer organ preservation in a prospective observational study. This study aims to determine whether the presence of ctDNA in blood specimens can detect rectal cancer response and risk of recurrence earlier.

To read the full MSK study, visit here. For the full MGH study, visit here. For companies interested in deploying C2i Genomics’ cancer intelligence technology, please visit www.c2i-genomics.com.

About C2i Genomics:

Founded in 2019, C2i Genomics has created the world’s leading cancer treatment intelligence platform that uses low-input blood (only 3-4mL blood) and offers ultra-sensitive whole-genome sequencing cancer detection and monitoring. With headquarters in NYC, CLIA lab in Cambridge MA, and an R&D center in Israel, C2i’s SaaS solution utilizes a cloud-based platform to perform cancer tumor burden monitoring on a global scale, leveraging the thousands of already installed genome sequencers around the world. Using cutting-edge scientific breakthroughs, growing genomic and clinical databases, and sophisticated computation and AI, C2i enables high-precision personalized medicine, reduced cancer treatment costs, and accelerated drug development. C2i was named to the 2021 CB Insights Digital 150 list and awarded the 2022 North American Digital Cancer Monitoring Platform Technology Innovation Leadership Award by Frost & Sullivan. For more information, please visit www.c2i-genomics.com.

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