Understanding Gaps in OS Data for Melanoma Adjuvant Therapy

Medscape

3 days ago

This transcript has been edited for clarity.
Welcome back, everybody. My name is Teresa Amaral, and it's a real pleasure to have you here for this melanoma series on Medscape. We have talked in the last two episodes about the current status of adjuvant therapy and its benefit in patients with stage III melanoma, and in the last episode we discussed the absence of overall survival (OS) benefit.
You may question why it is important to have this discussion in terms of the absence of OS benefit or the absence of data on the OS benefit. This absence of data might have three consequences, and I'm going to go through them with you.
The first one is associated with reimbursement. The fact that we will need to wait until 2028, most likely, to evaluate the OS benefit from adjuvant therapy compared to placebo in stage III might lead to some discussions in terms of the reimbursement and might lead some agencies to consider whether they would like to continue reimbursing this therapy or not in this setting.
Second, in some countries, the absence of OS data is leading to discussions on whether they will fund this therapy or not until there is clear proof that there is an OS benefit.
The third point is related to the fact that we don't knowthe patient's individual benefit. We also know that, depending on the stage, we might need to treat more patients to actually have one patient to prevent a recurrence.
For example, we know that in patients in stage IIB, we will have to treat between five and nine patients in stage IIB to prevent a recurrence. In patients with stage IIC, we need to treat between four and seven patients to prevent a recurrence.
All of these cost-effectiveness analyses are being done by the healthcare agencies, and this obviously needs to be taken into consideration when we are discussing these types of therapiesthat have a benefit in terms of relapse-free survival and distant metastasis-free survival but lack data in terms of OS benefit.
Another point is that, despite the fact that all the guidelines have been supporting the use of this therapy in stage III and stage IV — namely the ESMO guidelines and the ASCO guidelines— there is some uncertainty in terms of the OS benefit. This may lead to some difficult discussions and a lack of clear direction in terms of whatpatients should do when they need to make a decision on receiving adjuvant therapy or not.
The patients and their treating physicians may struggle with treatment choices due to this uncertainty and the fact that they don't know if there will be a long-term survival impact for this particular patient or not.
Here, we come to the first discussion that we had a couple of sessions before, which is the absence of prognostic and predictive biomarkers in this setting. Besides that, we really don't know the impact of these adjuvant treatments in terms of long-term benefitwhen we talk about OS, which might lead to reduced use of these therapies in stage III and stage II. This decline in terms of use of these adjuvant therapies has already been seen in some countries, like in Denmark.