Ivonescimab Medicine 04 June 2026 Extended indication Ivonescimab in combination with chemotherapy for first line treatment of metastatic without actionable genomic mutations, squamous non-small cell lung cancer in adults and elderly. Therapeutic value No estimate possible yet Total cost 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 chemotherapy for first line treatment of metastatic without actionable genomic mutations, squamous non-small cell lung cancer in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Summit Therapeutics Portfolio holder Summit Therapeutics Mechanism of action Route of administration Intravenous Therapeutical formulation Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Submission date December 2026 Expected Registration January 2028 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options PD-1 + chemo Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Uit de interimanalyse van de HARMONi-3 studie is gebleken dat de progression-free survival (PFS) niet voldoet aan de gestelde grens (na amendement). De independent data monitoring committee (iDMC) heeft het advies gegeven om door te gaan met de studie voor de primaire PFS analyse. De resultaten worden in de 2e helft van 2026 verwacht. Duration of treatment Frequency of administration Dosage per administration References NCT05899608 (HARMONi-3); Expertopinie Additional remarks Expected patient volume per year Patient volume < 1,470 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL 2023 (1); Perez-Moreno et al. Clin Cancer Res. 2012 (2); Expertopinie (3) Additional remarks In 2023 werden er 4.891 diagnoses stadium 4 NSCLC geregistreerd (1). Plaveiselcelcarcinoom komt voor bij 30% van de NSCLC-tumoren (2), wat uitkomt op 1.470 patiënten. Hiervan kunnen de patiënten die in aanmerking komen voor immunotherapie en een goede WHO-PS hebben worden behandeld met dit geneesmiddel (3). 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