Adela's Blood-Based Test Shows Strong Predictive Power for Immunotherapy Response in Advanced Solid Tumors
核心洞察
Adela (搜索)'s tissue-free methylated ctDNA (搜索) test demonstrated strong association with immunotherapy response, showing patients with decreased ctDNA levels had 31.77 times higher odds of objective response.
The validation study of 64 patients with advanced solid tumors (搜索) receiving pembrolizumab showed significant improvements in progression-free survival and overall survival for patients with decreasing ctDNA levels.
The test addresses a critical unmet need for early response monitoring in immunotherapy, potentially enabling clinicians to make treatment decisions by cycle 3 rather than waiting for conventional imaging results.
Adela (搜索), Inc. announced the publication of clinical validation results in npj Precision Oncology demonstrating that its tissue-free blood test can effectively monitor immunotherapy response in patients with advanced solid tumors (搜索). The study showed that changes in methylated circulating tumor DNA (ctDNA) measured between pre-treatment and cycle 3 initiation were strongly associated with treatment outcomes, potentially enabling earlier clinical decision-making.
Clinical Validation Results
The validation study analyzed banked samples from 64 patients with advanced head & neck, breast, ovarian, melanoma (搜索), or other solid tumors who received pembrolizumab at Princess Margaret Cancer Centre, University Health Network as part of the INSPIRE Study (NCT026344369). Blood samples were collected pre-treatment and prior to every three treatment cycles starting at cycle 3 of treatment.
Patients with a decrease in methylated ctDNA (搜索) between pre-treatment and pre-cycle 3 demonstrated significantly better outcomes compared to those with an increase in methylated ctDNA:
Treatment Response:
- Objective response: odds ratio (OR) = 31.77, 95% CI: 3.71–4173.19, P=0.0003
- Clinical benefit: OR = 15.55, 95% CI: 3.31–151.52, P=0.0002
Survival Outcomes:
- Progression-free survival: hazard ratio (HR) = 0.27, 95% CI: 0.14–0.50, P<0.0001
- Overall survival: HR = 0.49, 95% CI: 0.27–0.86, P=0.01
Addressing Unmet Clinical Need
In patients with advanced cancer receiving immunotherapy, there is a critical unmet need for sensitive, rapid turnaround tools to monitor treatment response during early treatment cycles. Using conventional imaging alone can lead to delayed recognition of non-response and missed opportunities to alter treatment. Most emerging molecular options for response monitoring require tumor tissue, which is often not available in patients with advanced cancer.
"The study supports the use of the test for response monitoring and the early identification of patients who are not responding to immunotherapy and could benefit from a different treatment approach," said Enrique Sanz-Garcia, MD, Medical Oncologist and Clinician Investigator at Princess Margaret Cancer Centre, University Health Network. "The test may thus be a useful tool to support clinical decisions regarding therapy continuation or discontinuation to optimize patient outcomes, and perhaps avoid unnecessary toxicity."
Technology Platform and Broader Applications
Adela (搜索)'s approach utilizes proprietary genome-wide methylome enrichment technology that captures biologically relevant information across the entire methylome, removing the need for disease-specific panels and supporting broad use across solid tumors and diverse clinical settings.
"We are pleased to announce the publication of the clinical validation of a second application of our genome-wide methylation-based platform," said Anne-Renee Hartman, MD, Chief Medical Officer at Adela (搜索). "Because our approach captures biologically relevant information across the entire methylome, it removes the need for disease-specific panels and supports broad use across solid tumors and diverse clinical settings."
The test has also been clinically validated for surveilling for recurrence in head and neck cancer, with results published in the Annals of Oncology.
Commercial Timeline
Adela (搜索)'s test is currently available for use in monitoring immunotherapy response by biopharmaceutical companies and other investigators, including for biomarker discovery and drug development. The company plans to commercialize the test later this year for use in patients with solid tumors treated with immunotherapy to monitor response and help guide treatment decision-making.