Cobolimab

Extended indication	Cobolimab in combination with dostarlimab and docetaxel for second line, third line treatment of advanced or metastatic EGFR-negative, ALK-negative, or ROS-1-negative Non-small cell lung cancer in adults and elderly who have progressed on prior anti-PD-(L)1 therapy and chemotherapy
Therapeutic value	No estimate possible yet
Registration phase	Clinical trials

Product

Active substance	Cobolimab
Domain	Oncology
Reason of inclusion	New medicine (specialité)
Main indication	Lung cancer
Extended indication	Cobolimab in combination with dostarlimab and docetaxel for second line, third line treatment of advanced or metastatic EGFR-negative, ALK-negative, or ROS-1-negative Non-small cell lung cancer in adults and elderly who have progressed on prior anti-PD-(L)1 therapy and chemotherapy
Manufacturer	GSK
Budgetting framework	Intermural (MSZ)
Additional remarks	Cobolimab is a monoclonal antibody against the inhibitory T-cell receptor, T-cell immunoglobulin and mucin domain-3 (TIM-3), with potential immune checkpoint inhibitory and antineoplastic activities.

Registration

Registration route	Centralised (EMA)
ATMP	No
Submission date	April 2025
Expected Registration	May 2026
Registration phase	Clinical trials
Additional remarks	NCT04655976

Therapeutic value

Therapeutic value	No estimate possible yet
Substantiation	De resultaten moeten nog worden afgewacht. De verwachting is dat het mogelijk wel wat kan gaan betekenen omdat docetaxel niet erg effectief is.

Expected patient volume per year

Patient volume	< 3,700 Market share is generally not included unless otherwise stated.
References	NKR2021
Additional remarks	In 2021 waren er 10.096 diagnoses NSCLC in Nederland. Dit betrof 1.727 patiënten in stadium I, 822 patiënten in stadium II, 2.231 patiënten in stadium III, 5.247 patiënten in stadium IV. Ongeveer 50% van de stadium III en stadium IV patiënten gaat door voor een tweede lijn therapie. Het zal ongeveer gaan om 3.700 patiënten.

Patient volume

< 3,700

Market share is generally not included unless otherwise stated.

References

NKR2021

Additional remarks

In 2021 waren er 10.096 diagnoses NSCLC in Nederland. Dit betrof 1.727 patiënten in stadium I, 822 patiënten in stadium II, 2.231 patiënten in stadium III, 5.247 patiënten in stadium IV. Ongeveer 50% van de stadium III en stadium IV patiënten gaat door voor een tweede lijn therapie. Het zal ongeveer gaan om 3.700 patiënten.

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.