Version 3

Zenocutuzumab

Medicine

Extended indication Zenocutuzumab monotherapy for second line treatment of advanced unresectable or metastatic NRG1 fusion-positive pancreatic cancer in adults and elderly.
Therapeutic value No estimate possible yet
Total cost € 1,190,000.00
Registration phase Clinical trials

Product

Active substance Zenocutuzumab
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Pancreatic cancer
Extended indication Zenocutuzumab monotherapy for second line treatment of advanced unresectable or metastatic NRG1 fusion-positive pancreatic cancer in adults and elderly.
Proprietary name Bizengri
Manufacturer Merus
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks HER2 en HER3 bispecifiek antilichaam.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date July 2026
Expected Registration August 2027
Orphan drug No
Registration phase Clinical trials
Additional remarks Tijdslijn op basis van IHSI-inschatting.

Therapeutic value

Current treatment options 1L: FOLFIRINOX of capecitabine met gemcitabine
Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation 204 patiënten met twaalf verschillende tumortypes kregen in de eNRGy trial zenocutuzumab. Bij patiënten met meetbare ziekte (n=158) reageerde 30% op de behandeling (95% CI: 23-37%), met een mediane responsduur van 11,1 maanden (95% CI: 7,4-12,9 maanden). De mediane progressievrije overleving was 6,8 maanden (95% CI: 5,5-9,1 maanden). Responsen werden gezien bij verschillende tumortypes, waaronder long- en pancreaskanker. Bijwerkingen waren meestal mild, met diarree, vermoeidheid en misselijkheid als meest voorkomende klachten. Eén patiënt stopte vanwege een bijwerking (1,2). De verwachting is dat de PASKWIL-criteria net worden gehaald (3).
Frequency of administration 1 times every 2 weeks
Dosage per administration 750mg
References NCT02912949 (eNRGy) (1); Schram et al. NEJM. 2025 (2); Expertopinie (3).

Expected patient volume per year

Patient volume < 14

Market share is generally not included unless otherwise stated.
References NKR 2022 (1); Clin Cancer Res (2019) 25 (16): 4966–4972 (2)
Additional remarks In 2022 waren er 2.890 diagnoses alvleesklierkanker (1). NRG+fusies komen voor in 0,5% van de alvleeskliertumors (2).

Expected cost per patient per year

Cost € 70,000.00 - 100,000.00

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 IHSI High Impact Report. 2023.
Additional remarks Op basis van Europese lijstprijzen van larotrectinib kan ingeschat worden dat zenocutuzumab tussen de €70.000 en €100.000 gaat kosten.

Potential total cost per year

Total cost € 1,190,000.00

Off label use

Indication extension

Other information