Concentrate for solution for infusion for the treatment of adults with HLA-A*02:01-positive, unresectable or metastatic uveal melanoma.

About the medicinal product

KIMMTRAK contains the active substance tebentafusp and is administered as an intravenous infusion.

KIMMTRAK is used in adults with a particular genetic trait (HLA-A*02:01)^[1] who have a rare type of eye cancer called uveal melanoma. The eye cancer is either so far advanced that it can no longer be removed (unresectable) and/or has already spread to other sites in the body (metastasised).

Since this is a rare and life-threatening disease, the medicine has been authorised as an orphan drug. “Orphan drug” is a designation given to medicinal products for rare diseases.

KIMMTRAK was authorised under Article 13 of the Therapeutic Products Act (TPA). This means that the medicinal product is already authorised in another country with comparable medicinal product control.

In this case, Swissmedic takes into consideration the results of checks carried out by foreign regulatory agencies, provided certain requirements are fulfilled. These involve checks on the quality, efficacy, and safety of the medicinal product, and the extent to which the results can be accepted for Switzerland.

The consideration of the results of foreign authorisation procedures is intended to help ensure that medicines that are already authorised abroad can be made available to patients in Switzerland as quickly as possible.

In deciding whether to authorise KIMMTRAK in Switzerland, Swissmedic accepted the assessment and approval decision of the European Medicines Agency (EMA; reference number EMEA/H/C/004929/0000) and has only conducted a limited scientific review.

Accordingly, in the SwissPAR (Swiss Public Assessment Report) and the resulting Summary report on authorisation, Swissmedic refers to the Assessment Report issued by the reference authority: www.ema.europa.eu

^[1] _{Genetic trait (HLA-A*02:01): A particular characteristic that is determined by a person’s genetic material. The HLA-A*02:01 trait is a particular marker on the surface of the cells in an individual’s body.}

Mode of action

The medicinal product KIMMTRAK contains the active substance tebentafusp, which was developed for the treatment of uveal melanoma. Tebentafusp is a protein developed specifically to bind to particular attributes of the cancer cells while simultaneously drawing immune cells to them. Thus, it acts like a bridge between the cancer cells and immune cells and helps the immune system specifically recognise and attack them. This slows or stops the growth of the tumour.

Administration

KIMMTRAK is a prescription-only medicine that is administered as an intravenous infusion. Before it is administered, KIMMTRAK is diluted with a special salt solution that contains albumin^[2]. It is administered under the instruction and supervision of an experienced doctor and may only be used in specialised centres that are capable of dealing with serious complications. The recommended dose of KIMMTRAK is 20 µg on day 1, increasing to 30 µg on day 8, 68 µg on day 15 and finally 68 µg weekly. Treatment continues for as long as the patient derives clinical benefit and does not experience unacceptable side effects.

^[2] _{Albumin: Protein that transports various substances in the blood and helps regulate the body’s water balance.}

Efficacy

The efficacy of KIMMTRAK was investigated in the IMCgp100-202 pivotal trial in patients with unresectable or metastatic HLA-A*02:01-positive uveal melanoma. Participants received either KIMMTRAK or, for the purposes of comparison, a control treatment chosen by the investigator (pembrolizumab, ipilimumab or dacarbazine).

The trial showed a significant improvement in overall survival^[3] compared with the chosen treatments in the control arm. Patients who received KIMMTRAK achieved a median overall survival of 21.7 months compared with 16.0 months for the control treatment. Progression-free survival (PFS)^[4] was also better with KIMMTRAK, with a median of 3.3 months compared with 2.9 months for treatment with one of the control medicines. The objective response rate was 10.3% for KIMMTRAK compared with 4.8% for the control treatment.

^[3] _{Overall survival: Overall survival (OS) refers to the period between the start of treatment and the death of the patient.}

^[4] _{Progression-free survival. Period between the start of a treatment or a clinical trial and the onset of disease progression or the death of the patient.}

Precautions, undesirable effects & risks

KIMMTRAK must not be used in those who are hypersensitive to the active substance or any of the excipients. The most common undesirable effects experienced by patients treated with KIMMTRAK were cytokine release syndrome (CRS)^[5], rash, fever, pruritus (itching), fatigue, nausea, chills, abdominal pain (stomach pain), oedema (water retention), hypopigmentation or hyperpigmentation (changes in skin colour), hypotension (low blood pressure), dry skin, headaches and vomiting. CRS and skin reactions present a particularly elevated risk of serious adverse reactions. Infusions should be administered under the supervision of a doctor, particularly for the first three treatments. KIMMTRAK can be used in elderly patients and patients with impaired liver or kidney function. However, particular caution is required for severe kidney or liver disorders.

All precautions, risks, and other possible undesirable effects are listed in the Information for healthcare professionals.

^[5] _{Cytokine release syndrome (CRS): A severe immune response that can cause fever, chills and circulatory problems.}

Why the medicinal product has been authorised

Switzerland does not currently have any authorised medicinal products for the specific treatment of advanced uveal melanoma, a disease with a poor prognosis and limited treatment options. The trials showed that KIMMTRAK offers patients with the HLA-A*02:01 genetic trait the chance of improved overall survival.

Taking all the risks and precautions into account, and based on the available data, the benefits of KIMMTRAK outweigh the risks. Swissmedic has therefore authorised the medicinal product KIMMTRAK, containing the active substance tebentafusp, for use in Switzerland.

Further information on the medicinal product

Information for healthcare professionals:

Healthcare professionals can answer any further questions.

^{The date of revision of this text corresponds to that of the SwissPAR. New information concerning the authorised medicinal product in question will not be incorporated into the Summary report on authorisation.}

^{Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals. New findings that could impair the quality, efficacy, or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.}