A decrease in methylated circulating tumor DNA (ctDNA) from pre-treatment to cycle 3 initiation was associated with significantly higher objective response, greater clinical benefit, and improved survival outcomes.

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FOSTER CITY, Calif., March 3, 2026 /PRNewswire/ -- Adela, Inc., an innovator in blood testing for molecular residual disease (MRD) monitoring and early cancer detection through a proprietary genome-wide methylome enrichment technology, today announced the publication of clinical validation results in  npj Precision Oncology for use of its test to monitor response to immunotherapy in patients with advanced solid tumors. 

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The study demonstrated that changes in methylated circulating tumor DNA (ctDNA) measured prior to treatment initiation and before cycle 3 of therapy were strongly associated with objective response and clinical benefit. These findings validated the test’s potential to support clinical decision-making regarding continuation or discontinuation of immunotherapy early in a course of treatment. 

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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, as 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. A tissue-free option offers broader accessibility.

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The validation study analyzed banked samples from 64 patients with advanced head & neck, breast, ovarian, melanoma, 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. 

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Compared to those with an increase in methylated ctDNA, patients with a decrease in methylated ctDNA between pre-treatment and pre-cycle 3 were more likely to achieve: 

• 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)

A decrease in methylated ctDNA was also associated with significantly better:

• 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).

“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. 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,” said Enrique Sanz-Garcia, MD, Medical Oncologist and Clinician Investigator at Princess Margaret Cancer Centre, University Health Network. 

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Adela’s test has also been clinically validated for surveilling for recurrence in head and neck cancer, with results published in the Annals of Oncology.

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“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. “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.”

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Adela’s test is currently available for use in monitoring immunotherapy response by biopharmaceutical companies and other investigators, including for biomarker discovery and drug development. Adela 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.