Informed Decision-Making for Patients Through Personalized Tumour Diagnostic and Treatment Information.
Pitch Initiative:
Merlin test is the first molecular test available in clinical practice that is optimized to decrease the number of invasive sentinel lymph node biopsy (SLNB) surgeries significantly by analyzing information from 8 tumor genes.1. SLNBs are performed to check whether the melanoma has spread to the lymph nodes. When the SLNB comes back positive for metastasis, the patient is eligible for adjuvant systemic treatment. About 80% of SLNBs1 are negative leaving the invasive surgery without discernible therapeutic effect while these patients have >10% risk of life long complications2. Furthermore, the patient path of SLNB surgery involves multiple hospital visits, tests, specialists and time to recover3.
Patients with a Merlin test low-risk result could safely forgo the SLNB surgery1 and have a favorable 5-year recurrence-free-survival when compared to Merlin high-risk patients4,5,6. These results allow for Merlin test to support informed clinician-patient decision-making, a few days after a life-changing diagnosis. On
the other hand, for Merlin high-risk patients, SLNB surgery is highly recommended. In cases with comorbidities, frailty, location of surgery (i.e. head and neck area), age or when patients have pre-operative anxiety, a Merlin high-risk result may provide additional support for an informed-decision on advancing
with the procedure.
Methods, size and scope:
Tumors are pathologically staged according to their thickness: thicker tumors are more likely to metastasize. SLNB’s are not indicated for the thinnest tumors (stage pT1a). Furthermore, the risk for nodal metastasis in the thickest tumors (pT3-4) is generally so substantial that these patients are usually referred for the procedure. Thus, Merlin test adds the most value in the group pT1b-pT2 patients. This group
accounts for approximately 33% (Europe/Australia) and 51% (USA) of all newly diagnosed cases.
Results:
- Large Dutch multicenter prospective trial7 shows Merlin’s ability to reduce the number of surgeries by approximately 40% at a negative predictive value (NPV) of 96.7% in a representative melanoma cohort. The study showed that Merlin test can be implemented in clinical practice and the results are in-line with previous retrospective studies.
- Three (USA8, Netherlands9, Sweden10) independent retrospective validation studies have shown Merlin’s ability to risk-stratify patients based on their risk for nodal metastasis.
- Long-term follow-up data shows a favorable 5-year recurrence-free-survival for Merlin low-risk patients compared to high-risk patients.4,5,6
- An SLNB-related complications study2 showed an overall 90-day complication rate of 17.4%. Most common complications were seroma, (skin) infection, and lymphedema. By reducing SLNBs, Merlin could reduce 59% of SLNB-related complications.
- A cost-effectiveness study11 showed that at a cost below $4,600 (pT1b-pT2), Merlin test was cost saving compared to no-testing strategy.