KIMMTRAK (tebentafusp) - Uveal melanoma

First assessment.

Key points

Favourable opinion for reimbursement as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

What therapeutic improvement?

Therapeutic improvement in the care pathway.

Role in the care pathway?

Around 50% of patients with uveal melanoma develop metastases.

Liver metastases are the most common (60%). Surgery may be considered to treat these metastases, but few patients are eligible for resection (< 10%).

The chemotherapy protocols indicated in the treatment of cutaneous melanoma including cisplatin, fotemustine, dacarbazine and temozolomide have been shown to be not very effective in the treatment of uveal melanoma.

Immunotherapies are used in the treatment of metastatic uveal melanoma by analogy with cutaneous melanoma (pembrolizumab, nivolumab, ipilimumab). However, these immunotherapies are not specific to the treatment of uveal melanoma, and the response rate obtained with these treatments is lower than that observed in the treatment of cutaneous melanoma.

The ASCO (2022) and NCCN (2022) guidelines recommend the use of tebentafusp in human
leukocyte antigen (HLA)-A*02:01-positive patients with metastatic uveal melanoma. For the remaining patients who cannot benefit from tebentafusp, the ASCO (2022) guidelines indicate that, at present, no recommendations can be made relative to the use of systemic treatments. For these patients, inclusion in clinical trials remains possible.

Role of KIMMTRAK (tebentafusp) in the care pathway:

KIMMTRAK (tebentafusp) as monotherapy is a first-line treatment for human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

In accordance with the SmPC, the Committee wishes to draw attention to the specific safety profile of KIMMTRAK (tebentafusp), in particular the risks of the occurrence of acute skin reactions and cytokine release syndrome (CRS) requiring monitoring for at least 16 hours following thethree infusions of tebentafusp in a hospital setting with immediate access to medicinal products and resuscitative equipment to manage CRS. The risk of sequelae associated with CRS may be higher in patients with pre-existing cardiovascular disorders and these patients should be closely monitored.

The summary of product characteristics (SmPC) and the risk management plan (RMP) must be complied with and special monitoring during and after treatment is required. In particular an ECG should be performed before and after infusion during the first 3 weeks of treatment with tebentafusp and subsequently as clinically indicated.