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Bemarituzumab

Extended indication

Eerstelijnsbehandeling bij niet-operabel, lokaal gevorderd of gemetastaseerd HER2- en FGFR2b+ maagka

Therapeutic value

No estimate possible yet
Registration phase

Clinical trials

Product

Active substance

Bemarituzumab
Domain

Oncology
Reason of inclusion

New medicine (specialité)
Main indication

Stomach cancer
Extended indication

Eerstelijnsbehandeling bij niet-operabel, lokaal gevorderd of gemetastaseerd HER2- en FGFR2b+ maagkanker/gastro-esophageal junction kanker
Manufacturer

Amgen
Portfolio holder

Amgen
Mechanism of action

Other, see general comments
Route of administration

Intravenous
Therapeutical formulation

Intravenous drip
Budgetting framework

Intermural (MSZ)
Additional remarks 
werkingsmechanisme: FGFR2b Monoklonaal antilichaam

Registration

Registration route

Centralised (EMA)
ATMP

No
Submission date

2025
Expected Registration

2026
Orphan drug

No
Registration phase

Clinical trials

Therapeutic value

Current treatment options

Platinum bevattende chemotherapie (FOLFOX)
Therapeutic value

No estimate possible yet
Substantiation

De lopende fase 3 studie vergelijkt FOLFOX + bemarituzumab vs FOLFOX als 1e lijnsbehandeling. Tijdens de primaire analyse en bij een mediane follow-up van 10,9 maanden (IQR 6,3–14,2), was de mediane progressie-vrije survival 9,5 maanden (95% CI 7·3–12·9) in de bemarituzumab groep en 7,4 maanden (5·8–8·4) in de placebogroep (hazard ratio [HR] 0·68 [95% CI 0·44–1·04; p=0,073).
Frequency of administration

1 times every 2 weeks
Dosage per administration

15 mg/kg
References 
NCT05052801; Lancet Oncology oct 2022: Randomised, double-blind, placebo-controlled phase 2 trial (FIGHT)

Expected patient volume per year

References 
1. IKNL; 2. Rapport Slokdarm en maagkanker in Nederland (https://iknl.nl/slokdarm-en-maagkanker);
3. Rapport kanker in Nederland in 2032 (IKNL 2023)
Additional remarks 
In 2022 waren er 1.102 maagkanker plus 452 GEJ/cardiakanker diagnoses. 
Stadium IV: 48% maagkanker + 38% GEJ/cardiakanker (totaal 701 patiënten). HER2-: ~80% (561 patiënten)
FGFR2b overexpression >10%: 15-20% (84-112 patiënten) 33% maagkanker en 37% GEJ/cardiakanker patiënten krijgen systemische behandeling in 1L (29-38 patiënten)

Expected cost per patient per year

Additional remarks 
prijs onbekend

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use

No

Indication extension

Indication extension

Yes
Indication extensions

1e lijn behandeling in combinatie met platinum-bevattende chemotherapie en immuuntherapie
References 
https://clinicaltrials.gov/study/NCT05111626?cond=Gastric%20Cancer&intr=Bemarituzumab&aggFilters=phase:3&rank=2

Other information

There is currently no futher information available.