The ability of Adela’s assay to quantify cfDNA cancer signal and predict recurrence was evaluated in individuals diagnosed with stage I-IVB human papillomavirus (HPV)-negative and HPV-positive head and neck cancer treated at University Health Network - Princess Margaret Cancer Centre. This training analysis included 432 plasma samples collected from 130 patients (a subset of the full cohort of >1,100 plasma samples from >300 individuals). Blood draws occurred before and after curative intent treatment, and in a subset of patients, at 12 and 24 months post-curative intent treatment. 

Key Highlights:

• Adela’s MRD assay demonstrated the ability to identify patients more likely to recur than not, based on the landmark blood draw (mean 3 months following curative intent treatment), and also at the surveillance time points.

• Significant differences in recurrence-free survival (RFS) were observed, with a hazard ratio (HR) of 6.31 at the landmark time point, and an HR of 12.95 for surveillance time points, when patients were stratified by MRD positivity. MRD status correlated with RFS in both HPV-positive and HPV-negative diseases. The lead time between MRD positivity and recurrence was up to 19.3 months, with a mean lead time of 5.1 months.

Limitations:

• A limited number of surveillance blood draws were available in the cohort. 

• This results in a potential underestimation of detectability and lead time. 

• Cross-fold validation was used to reduce the bias of the performance estimate.

• Assessing test performance in an independent set of samples will provide a more accurate validation of results.

Next steps:

• Final training and validation of the assay in a held-out test set is ongoing and will be reported in the future.

• After completion of clinical validation, the detection of cfDNA cancer signal has numerous practical advantages in both research and clinical settings; to guide curative intent treatment and detect recurrence before the current standard of care.

A Research Use Only (RUO) version of Adela’s MRD test is currently available to biopharmaceutical companies and other investigators for use in biomarker discovery and drug development. Adela plans to commercialize the test for clinical use in 2025.

KOL insights

“MRD tests have the potential to allow clinicians to personalize patient treatment based on the likelihood of future recurrence. Additionally, these tests can help identify patients who might benefit from closer monitoring with imaging to detect and treat a recurrence at the earliest opportunity” – Expert Opinion.

Conclusion

The data presented by Adela showcased the novel blood test's capability to detect and quantify cancer signals in the blood. This test stands out from others as it doesn't rely on associated tumor tissue. Once validated, it will offer clinicians valuable information to assist in deciding on cancer therapies and enable early detection and treatment of recurrences. Additionally, it can help identify patients suitable for clinical trials.