Pembrolizumab / favezelimab

Extended indication	Patients With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer
Therapeutic value	No estimate possible yet
Registration phase	Clinical trials

Product

Active substance	Pembrolizumab / favezelimab
Domain	Oncology
Reason of inclusion	New medicine (specialité)
Main indication	Colon cancer
Extended indication	Patients With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer
Manufacturer	MSD
Portfolio holder	MSD
Mechanism of action	Combination therapy
Route of administration	Intravenous
Budgetting framework	Intermural (MSZ)
Additional remarks	Co-formulation of PD-1 inhibitor and LAG-3 inhibitor

Registration

Registration route	Centralised (EMA)
Particularity	New therapeutical formulation
ATMP	No
Submission date	2025
Expected Registration	2026
Orphan drug	No
Registration phase	Clinical trials

Therapeutic value

Current treatment options	TAS-102
Therapeutic value	No estimate possible yet
Substantiation	Er zijn nog geen resultaten. De studie loopt tot augustus 2024.
Duration of treatment	Maximal 2 year / years
Frequency of administration	1 times every 3 weeks
Dosage per administration	favezelimab/pembrolizumab 800mg/200mg
References	NCT05064059
Additional remarks	Bispecifiek antilichaam tegen PD-L1 en LAG3 en stimuleert tumorcel afbraak T-cellen via dendritische cel-activatie. De Fase 3 studie loopt nog. Fase 1 laten geringe respons zien en te managen toxiciteit.

Expected patient volume per year

Patient volume	500 - 550 Market share is generally not included unless otherwise stated.
References	NKR2021 (1); Expertopinie (2).
Additional remarks	Gemetastaseerde coloncarcinoom betreft 2.085 patiënten in stadium 4 (1). Bij een positief resultaat komt een selectie van de patiënten die momenteel behandeld worden met regorafenib of TAS102 in aanmerking voor favelimab/pembrolizumab (2).

Patient volume

500 - 550

Market share is generally not included unless otherwise stated.

References

NKR2021 (1); Expertopinie (2).

Additional remarks

Gemetastaseerde coloncarcinoom betreft 2.085 patiënten in stadium 4 (1). Bij een positief resultaat komt een selectie van de patiënten die momenteel behandeld worden met regorafenib of TAS102 in aanmerking voor favelimab/pembrolizumab (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.