C2i Genomics and Gustave Roussy Collaborate to Demonstrate Utility of ctDNA-guided Immunotherapy in Early-Stage Solid Tumors

• The UMBRELLA Trial will investigate the clinical utility of escalating immunotherapy for cancer patients with molecular residual disease after completion of standard of care treatment to improve patients’ clinical outcome across a variety of solid cancers
• Immunotherapy will be decided based on circulating tumor DNA molecular residual disease testing in a randomized multicenter trial on patients with non-small cell lung cancer (NSCLC), breast cancer, colorectal cancer, pancreatic or soft-tissue sarcoma
• This breakthrough research will help to support the inclusion of ctDNA-based immunotherapy escalation for early stage solid cancers
  

C2i Genomics, a cancer intelligence company, and Gustave Roussy, 3rd comprehensive cancer center on a world stage, today announced a new collaborative trial, ’The UMBRELLA Trial,’ aimed at establishing the clinical utility of circulating tumor DNA (ctDNA) based molecular residual disease (MRD) testing in guiding immunotherapy escalation in the post-definitive care setting across early-stage solid tumors. The collaboration brings together the expertise and resources of each organization to perform a randomized multicenter clinical trial across multiple hospitals in France. Gustave Roussy will act as a central clinical partner in France throughout the research process.

The collaborative randomized Phase 2 trial sponsored by Gustave Roussy will investigate the impact of systemic treatment with tislelizumab, BeiGene’s potentially differentiated anti-PD-1 monoclonal antibody, or a placebo after detecting molecular residual disease (ctDNA positive) in early-stage patients with high risk of recurrence. Testing will occur three months after completion of surgery and perioperative treatment in patients with non-small cell lung cancer (NSCLC), breast cancer, colorectal cancer, pancreatic or soft-tissue sarcoma.

“We believe that MRD testing and monitoring are important tools for improving cancer care and enabling physicians to better tailor treatments to each patient,” said Ezra Sofer, CEO of C2i Genomics. “We are pleased to work with Gustave Roussy to advance this field by addressing the current clinical utility evidence gaps.”

Detection of ctDNA following curative therapy for early-stage cancers is associated with a high risk of future relapse, with clinical validity shown in multiple studies. However, a recent review by the ESMO Translational Research and Precision Medicine Working Group identified that there is still insufficient evidence for adopting ctDNA-based MRD detection in routine practice. While a growing body of evidence supports the use of MRD-guided therapy, a need remains for more prospective clinical trial data across solid cancers that demonstrate improved outcomes or quality of care for treatment escalation or de-escalation decisions. This collaboration aims to generate clinical utility evidence that can support the inclusion of ctDNA-based MRD testing into international guidelines. This study will also collect data on quality of life and cost-effectiveness.

“We are excited to collaborate with C2i Genomics to further develop the clinical evidence supporting ctDNA-based detection of MRD for personalized treatment decisions. With improved insight, physicians can identify patients most in need of treatment while de-intensifying therapy in patients that respond well to initial curative intervention,” said Professor Antoine Italiano, Head of Precision Medicine at Gustave Roussy. "This collaboration will allow Gustave Roussy to leverage our expertise in cancer research to develop and advance innovative treatment guidelines.”

The collaborative trial will use C2i Genomics’ validated software-as–a-medical-device C2inform test for MRD detection. Based on advanced bioinformatics and artificial intelligence technology, C2inform enables optimized detection and accurate monitoring of ctDNA from whole genome sequencing. Tislelizumab was selected as the trials’ experimental therapy given the success of immunotherapy in treating patients with metastatic disease in various tumor types and the growing body of evidence that there is a benefit of immunotherapy in the low disease burden setting.
The results of the breakthrough UMBRELLA trial are expected to help inform physicians’ decision-making and assist them in personalizing cancer care for patients with different types of solid tumors.

About Gustave Roussy:
Ranked as the leading European Cancer Centre and third in the world, Gustave Roussy is a centre with comprehensive expertise and is devoted entirely to patients suffering with cancer. The Institute is a founding member of the Paris Saclay Cancer Cluster. It is a source of diagnostic and therapeutic advances. It caters for almost 50,000 patients per year and its approach is one that integrates research, patient care and teaching. It is specialized in the treatment of rare cancers and complex tumors and it treats all cancers in patients of any age. Its care is personalized and combines the most advanced medical methods with an appreciation of the patient’s human requirements. In addition to the quality of treatment offered, the physical, psychological and social aspects of the patient’s life are respected. 4,100 professionals work on its two campuses: Villejuif and Chevilly-Larue. Gustave Roussy brings together the skills, which are essential for the highest quality research in oncology: 40% of patients treated are included in clinical studies. For further information: www.gustaveroussy.fr/en, Twitter, Facebook, LinkedIn, Instagram

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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