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Tislelizumab

Extended indication 1L locally advanced or metastatic gastric carcinoma
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Tislelizumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Stomach cancer
Extended indication 1L locally advanced or metastatic gastric carcinoma
Manufacturer BeiGene
Portfolio holder BeiGene
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Injection / infusion solution
Budgetting framework Intermural (MSZ)
Additional remarks Precieze indicatie nog onbekend

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2024
Expected Registration 2025
Orphan drug No
Registration phase Clinical trials
Additional remarks Fabrikant verwacht registratie in 2024.

Therapeutic value

Current treatment options Chemotherapie en PD-1/PD-L1 inhibitors plus chemotherapie.
Therapeutic value No estimate possible yet
Substantiation Nivolumab plus chemotherapie is al geregistreerd voor de eerstelijn. Tislelizumab zal mogelijk de concurrentie aangaan. In de studie van Xu et al. 2020 werd veiligheid aangetoond.
Duration of treatment Average 9 month / months
Frequency of administration 1 times a day
Dosage per administration 200mg
References Xu et al 2020; Rationale 305: Phase 3 study of tislelizumab plus chemotherapy vs placebo plus chemotherapy as first-line treatment (1L) of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). Markus H. Moehler, Ken Kato, Hendrik-Tobias Arkenau, Do-Youn Oh, Josep Tabernero, Marcia Cruz-Correa, HongWei Wang, Hui Xu, Jiang Li, Silu Yang, and Rui-hua Xu; Journal of Clinical Oncology 2023 41:4_suppl, 286-286
Additional remarks Betreft klinische studie RATIONALE-305

Expected patient volume per year

Patient volume

< 532

Market share is generally not included unless otherwise stated.
References NKR2021(1);
Additional remarks De incidentie van maagcarcinoom betrof 1.109 (1) patiënten, waarbij 48% procent sprake is van palliatief stadium. Er wordt vooralsnog uitgegaan dat dit uitsluitend adenocarcinoom omvat. In de studie zijn ook patiënten met GEJ geïncludeerd, maar een accurate inschatting van de omvang van deze groep is lastig te maken. Dit is echter significant lager dan het gedeelte met maagcarcinoom.

Expected cost per patient per year

References Cost-effectiveness analysis of tislelizumab, nivolumab and docetaxel as second- and third-line for advanced or metastatic non-small cell lung cancer in China. Front Pharmacol. 2022 Aug 25.
Additional remarks De prijs in Nederland is nog niet bekend. In een kosteneffectiviteit studie bij longkanker lijkt de prijs per patiënt wel lager uit te vallen dan bij bijvoorbeeld de PD-L1 remmer nivolumab.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use No

Indication extension

Indication extension Yes
Indication extensions Verschillende klinische studies lopen binnen longkanker en gastro-intestinale tumortypes

Other information

There is currently no futher information available.