IO102-IO103 Medicine 03 December 2024 Extended indication IO102-IO103 in combination with pembrolizumab for first line treatment of stage III (unresectable) or stage IV metastatic melanoma in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance IO102-IO103 Domain Oncology Reason of inclusion New medicine (specialité) Main indication Skin cancer Extended indication IO102-IO103 in combination with pembrolizumab for first line treatment of stage III (unresectable) or stage IV metastatic melanoma in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Io Biotech Portfolio holder Mechanism of action Other, see general comments Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date June 2025 Expected Registration July 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indieningsdatum en verwachte registratie op basis van IHSI-inschatting. Therapeutic value Current treatment options Nivolumab met ipilimumab Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er is nog enkel data beschikbaar van vroege klinische studies gecombineerd met PD-1/PDL-1-remmers. Er is al wel een mediane PFS aangekondigd van 25,5 maanden (1,2). Verdere data moet worden afgewacht voordat er een uitgebreidere inschatting gemaakt kan worden van de therapeutische waarde. Duration of treatment Average 2 year / years Frequency of administration 1 times every 3 weeks Dosage per administration 85 µg References NCT05155254 (IOB-013/KEYNOTE-D18) (1); Persbericht IO Biotech (2). Additional remarks 85µg elke drie weken gedurende maximaal 35 cycli (behandeling tot 2 jaar). Een aanvullende dosis kan worden gegeven tijdens de inductieperiode op dag 8 van cycli 1 en 2. Iedere patiënt kan in totaal worden behandeld met maximaal 37 toedieningen (tot 2 jaar behandeling). Expected patient volume per year Patient volume < 700 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021 (1); GIPdatabank (2). Additional remarks In 2021 waren er 7.670 gevallen van huidkanker. Hiervan betrof het 695 keer stadium III en 83 keer stadium IV (1). Dit betekent dat er maximaal 778 patiënten in aanmerking zullen komen. Er zijn ongeveer 700 patiënten die in de eerstelijn nivolumab met ipilimumab krijgen (2). 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks