Nogapendekin Alfa Inbakicept Medicine 04 December 2025 Extended indication Nogapendekin alfa inbakicept in combination with pembrolizumab, carboplatin and nab-paclitaxel for first line treatment of advanced or metastatic, stage 3 or 4 Non-small cell lung cancer in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Nogapendekin Alfa Inbakicept Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Nogapendekin alfa inbakicept in combination with pembrolizumab, carboplatin and nab-paclitaxel for first line treatment of advanced or metastatic, stage 3 or 4 Non-small cell lung cancer in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer ImmunityBio Portfolio holder ImmunityBio Mechanism of action Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Nogapendekin alfa inbakicept is een eerste-in-zijn-klasse IL-15-agonist die CD4-positieve T-cellen activeert en prolifereert. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Submission date January 2026 Expected Registration February 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Sluice candidate Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Immunotherapie Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Resultaten dienen nog afgewacht te worden. Dit is een nieuw werkingsmechanisme binnen deze indicatie. Op dit moment lopen er studies die het vergelijken met immunotherapie. Onder andere nab-paclitaxel, dat wordt in Nederland niet gegeven in deze setting. Hier zijn vooralsnog geen positieve resultaten uit bekend. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 15μg/kg References NCT03520686 Additional remarks Inductie (vier cycli): Dag een, elke drie weken, 15 μg/kg; Onderhoud: Dag een, elke drie weken, 15 μg/kg. Expected patient volume per year Patient volume 7,382 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1: NKR2022; Additional remarks In 2022 waren er 10.066 diagnoses NSCLC in Nederland. Dit waren 1.816 patiënten in stadium 868 patiënten in stadium II, 2.247 patiënten in stadium III, 5.135 patiënten in stadium IV. Uitgaande van stadion III/IV komt dat neer op zo'n 7.382 patiënten. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks