Concentrate for solution for infusion for second-line monotherapy following progression during or after platinum-based systemic therapy in adults with advanced or metastatic oesophageal squamous cell carcinoma who have yet to receive treatment with immune checkpoint inhibitors

About the medicinal product

Tevimbra contains the active substance tislelizumab. It is used to treat adults with advanced or metastatic oesophageal squamous cell carcinoma (cancer of the oesophagus).

Tevimbra is used as monotherapy (the only medicinal product used for treatment) in patients whose disease progresses during or after platinum-based chemotherapy. Since conventional surgical resection or chemotherapy on its own is not sufficiently effective in these patients, Tevimbra is used as second-line treatment. Furthermore, patients will not previously have received any other immunotherapy.

The primary aim of the medicinal product is to increase the patient survival rate by promoting an immune response to cancer cells.

Mode of action

The active substance in Tevimbra, tislelizumab, is a monoclonal antibody (immunologically active protein) that binds to a specific protein known as PD-1 (programmed cell death receptor-1) and thereby prevents it from binding to the PD-ligand (programmed cell death-ligand). As a result, the immune response is inhibited, and the growth of the cancer can be delayed or stopped.

Administration

Tevimbra is a prescription-only medicinal product that is available as a concentrate for solution for infusion. The recommended dose of Tevimbra is 200 mg and is administered every 3 weeks as an intravenous solution (into the veins).

Efficacy

The efficacy of Tevimbra as monotherapy versus chemotherapy in patients with unresectable locally advanced, recurrent, or metastatic oesophageal squamous cell carcinoma was investigated in global study BGB-A317-302.

Half the 512 patients received Tevimbra (200 mg intravenously every 3 weeks), while the other half received investigator's choice chemotherapy (paclitaxel, docetaxel, or irinotecan).

The primary efficacy endpoint^[1] was overall survival (OS)^[2]. Median^[3] OS in the overall population was 8.6 months for patients treated with Tevimbra, and 6.3 months for patients treated with investigator's choice chemotherapy.

The data underwent additional analysis according to PD-L1 expression.

^[1] _{Primary efficacy endpoint: The primary endpoint is the main objective of the study determined before it starts. If the primary endpoint is reached or exceeded, the study is formally deemed to have a positive outcome. Secondary endpoints, on the other hand, refer to other effects that do not clearly prove efficacy or that do not allow any clear conclusions to be drawn about the actual target criterion (primary endpoint).}

^[2] _{Overall survival (OS): refers to the period between the start of treatment and the death of the patient.}

^[3] _{Median: the value that lies exactly in the middle of a distribution of data is called the median or central value. Half of the data values are always less than the median, the other half are always greater.}

Precautions, undesirable effects & risks

Tevimbra must not be used in those who are hypersensitive to the active substance or any of the excipients.

The most frequent adverse effects (affecting more than 1 in 10 patients) are reduced count of white blood cells (leukocytes, neutrophils) and platelets (thrombocytes) in the blood, reduced lymphocyte count, low haemoglobin (blood pigment), lack of thyroid hormones (hypothyroidism), lower potassium and sodium levels, diarrhoea, cough, increased levels of aspartate aminotransferase, alanine aminotransferase^[4], alkaline phosphatase and bilirubin^[5], lower albumin levels, rash, itching, fatigue, elevated creatine kinase (heart and skeletal muscle enzyme), and elevated creatinine (kidney function indicator).

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

^[4] _{Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are enzymes produced mainly in the liver. Elevated levels of activity of these enzymes in the blood may indicate liver-related diseases.}

^[5] _{Bilirubin forms as a result of the breakdown of the blood pigment haemoglobin, and an elevated bilirubin level in the blood may be a sign of liver damage.}

Why the medicinal product has been authorised

As second-line treatment in patients with advanced or metastatic oesophageal squamous cell carcinoma, Tevimbra displays a significant and clinically relevant benefit in terms of overall survival compared with the control group who received chemotherapy.

There is a strong need for new treatment options in this patient group, since the treatment options available to them are often limited, and their prognosis is poor.

Taking all the risks and precautions into account, and based on the available data, the benefits of Tevimbra outweigh the risks. Swissmedic has therefore authorised the medicinal product Tevimbra, containing the active substance tislelizumab, in Switzerland for the second-line treatment of patients with squamous cell carcinoma of the oesophagus.

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.}