Ivonescimab Medicine 04 December 2025 Extended indication Ivonescimab in combination with pemetrexed and carboplatin for second line treatment of locally advanced or metastatic EGFR-mutant Non-squamous non-small cell lung cancer in adults and elderly who have progressed on or following EGFR-TKI treatment. Therapeutic value No estimate possible yet Total cost € 24,750,000.00 Registration phase Clinical trials Product Active substance Ivonescimab Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Ivonescimab in combination with pemetrexed and carboplatin for second line treatment of locally advanced or metastatic EGFR-mutant Non-squamous non-small cell lung cancer in adults and elderly who have progressed on or following EGFR-TKI treatment. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Summit Therapeutics Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Infusion fluid Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date August 2026 Expected Registration September 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er is een internationale HARMONi-studie waarin niet enkel patiënten van binnen China geïncludeerd zijn. Volgens een recente interim analyse gaf de gecombineerde behandeling hierin een significant PFS-voordeel (HR 0,52), maar geen significant overall survivalvoordeel. Er volgen later dit jaar meer resultaten. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 20 mg/kg ivonescimab in combinatie met pemetrexed 500mg/m² en carboplatin AUC .5 per cyclus. References Fase 3 HARMONi studie (NCT06396065) Additional remarks Expected patient volume per year Patient volume < 550 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL; Dingemans et al., Cancers (Basel) 2021;13(14):3641. DOI: 10.3390/cancers13143641 Additional remarks In 2022 waren er 10.066 diagnoses NSCLC in Nederland. Dit waren 1.816 patiënten in stadium 1, 868 patiënten in stadium 2, 2247 patiënten in stadium 3, 5135 patiënten in stadium 4. Uitgaande van stadion 3 en 4 komt dat neer op zoʼn 7.382 patiënten. Het aantal NSCLC patiënten met EGFR betreft zoʼn 5 tot 10% van deze patiënten. Het is de verwachting dat een groot gedeelte van de patiënten uiteindelijk ook in de tweedelijn behandeld zal worden. Expected cost per patient per year Cost € 30,000.00 - 60,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References GIPdatabank, Horizonscan Additional remarks Gegeven de andere PD1-remmers binnen dit indicatiegebied is de verwachting dat de kosten €30.000 tot €60.000 per patiënt per jaar zullen bedragen. Potential total cost per year Total cost € 24,750,000.00 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