1 August 2023

New data further validates AMBLor^® biomarker diagnostic test in the stratification of low-risk melanomas

With skin cancer being the most commonly diagnosed cancer in the US and the percentage of people developing melanoma in the US doubling over the last 30 years, there is growing concern for the rise in melanoma incidence and the way it is currently managed. Melanoma is the deadliest form of skin cancer. An estimated 99,780 new cases of invasive melanoma were diagnosed in the US during 2022. The story is the same in the UK, with a significant increase in melanoma diagnoses over the last few decades, with around 16,700 new cases every year.

Lack of accurate melanoma risk stratification negatively impacts patient wellbeing and healthcare resources

Melanoma disease staging is based on the American Joint Committee on Cancer (AJCC) criteria where early-stage melanomas are treated by surgical excision and all patients are clinically followed up for approximately 5 years post-diagnosis.

Sentinel lymph node biopsy (SLNB) is the gold standard for determining lymph node involvement and risk of tumour progression. A total of 88% of melanoma patients undergoing a SLNB will have a negative result. This prognostic information can guide therapeutic management options, however, SLNB is an invasive procedure that has been associated with overdiagnosis concerns (finding lesions that would not cause harm), false-negatives in up to 21% of cases (lesions that are recorded as benign but then reoccur) and complications including lymphoedema, seroma, haematoma, wound infection, nerve injury and deep vein thrombosis. Only around 20% of patients with early AJCC stage I or II melanomas will actually progress to metastatic disease, yet all patients are typically treated with the same procedures and follow-up schedules. This indicates a need for a prognostic test that will give clinicians an opportunity to assess the requirement for an invasive SLNB and to will enhance the prognostic picture for the individual.

‘Scanxiety’ is a term in oncology that describes the increased level of anxiousness patients feel before, during and after a scan to diagnose, monitor or determine reoccurrence of cancer. It’s a very common feeling for people whose lives have been changed by a melanoma diagnosis; sometimes, the anxiety is so overwhelming that it impacts on daily life.

Better risk stratification of melanomas is needed to spare patients with low-risk tumours from the psychological impact and time burden of unnecessary follow-up consultations, as well as potentially reducing the use of SLNB procedures in a standard follow-up pathway.

AMBLor^® can support clinicians to stratify patients with low-risk melanomas

AMBLor^® is a prognostic technology that identifies the presence or absence of biomarkers AMBRA1 and loricrin in the epidermis overlying non-ulcerated AJCC Stage I and II melanomas. Maintaining one or both biomarkers identifies tumours at low risk of progression. Through segmentation of melanoma patients into low-risk and at-risk groups, AMBLor^® may help inform decisions arising from other tests, such as SLNB, meaning patients could follow a more appropriate personal treatment and follow-up route. The latest data, presented at ASCO 2023, revealed retention of AMBLor^® in melanomas (discovery cohort) which correlated with significantly increased recurrence-free survival of 96%, compared to 87% for whom AMBLor^® was lost. Similarly, the validation arm of the study confirmed retention of AMBLor^® was associated with increased recurrence-free survival of 98% compared to 81% for patients with stage I/II tumours in which AMBLor^® was lost. The full dataset will be published later this year.

Read full press release here