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IO102-IO103

Extended indication IO102-IO103 in combination with pembrolizumab for first line treatment of stage III (unresectable) o
Therapeutic value No estimate possible yet
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.
Manufacturer IO Biotech
Mechanism of action Other, see general comments
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
ATMP No
Submission date June 2025
Expected Registration July 2026
Orphan drug No
Registration phase Clinical trials
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
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.
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

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.