Adela Inc. presented compelling data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrating that its tissue-agnostic minimal residual disease (MRD) test can predict treatment outcomes and identify non-responders to immunotherapy across multiple solid tumor types. The results, spanning two studies with 127 patients, suggest the methylation-based circulating tumor DNA (ctDNA) technology could address a critical clinical need in cancer care.
Breakthrough Results in Immunotherapy Response Prediction
The first study examined banked samples from 64 patients with advanced head and neck, breast, ovarian, melanoma, or other solid tumors who received pembrolizumab. Blood samples were collected pre-treatment and prior to initiation of cycle 3 of treatment. Patients showing a decrease in ctDNA from pre-treatment to pre-cycle 3 demonstrated significantly better progression-free survival with a hazard ratio of 0.28 (0.15, 0.49; p<0.0001) and overall survival with a hazard ratio of 0.42 (0.24, 0.76; p=0.003).
"In patients with advanced cancer receiving immunotherapy, it can be challenging to differentiate true progression from pseudoprogression during early treatment cycles based on imaging," said Dr. Lillian Siu, Medical Oncologist and Senior Scientist at Princess Margaret Cancer Centre, University Health Network. "To better identify non-responders and guide timely treatment adjustments, more reliable response assessment tools are needed. Methylation-based circulating tumor DNA technology shows promise in these regards."
Validation in Lung Cancer Patients
The second study provided additional validation using banked samples from 63 patients with stage III/IV non-small cell lung cancer. These patients were treated with definitive chemoradiation followed by consolidative durvalumab for stage III disease, or with PD-1 inhibitors with or without chemotherapy for stage IV disease. Blood samples were collected pre-treatment, 2-4 weeks after treatment initiation, and approximately 6-8 weeks thereafter until progression.
Patients with a positive MRD test showed significantly worse progression-free survival compared to those who tested negative, with a hazard ratio of 4.8 (95% CI, 2.1-10.8; P < 0.0001).
Clinical Implications and Universal Accessibility
Dr. Enrique Sanz-Garcia, Medical Oncologist and Clinician-Investigator at Princess Margaret Cancer Centre, emphasized the clinical significance: "These results show promise in assessing response to immunotherapy early in a patient's course of treatment. Identifying non-response earlier can support timely treatment decisions and help avoid unnecessary toxicity."
The tissue-agnostic nature of Adela's test addresses a significant limitation in current cancer care. "Because tumor tissue is often unavailable in patients with advanced cancer, Adela's blood-only, tissue-free approach offers a universally accessible solution for this population," explained Dr. Anne-Renee Hartman, Chief Medical Officer at Adela.
Technology Platform and Commercial Plans
Adela's MRD test is based on its genome-wide methylome enrichment platform, which efficiently captures extensive, biologically-relevant genomic information from the methylome. This approach provides greater opportunity to detect cancer signals in the blood compared to platforms that target a smaller set of genomic regions.
The test is currently available to biopharmaceutical companies and investigators for Research Use Only, including for biomarker discovery and drug development. Adela plans to commercialize the test in 2025 for use in patients who have received curative intent treatment for head and neck cancer, regardless of HPV status, to detect recurrence earlier and help guide treatment decision-making.
Future Directions
"Together, these two studies demonstrate the potential of Adela's tissue-agnostic test to predict outcomes and support clinical decision-making for patients receiving immunotherapy across a range of cancer types," said Dr. Hartman. The company's first product utilizing this genome-wide methylome enrichment platform was recently clinically validated for predicting and surveilling for recurrence in patients with head and neck cancer and published in Annals of Oncology.
