Domvanalimab

Extended indication	previously untreated locally advanced unresectable or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinoma
Therapeutic value	No estimate possible yet
Registration phase	Clinical trials

Product

Active substance	Domvanalimab
Domain	Oncology
Reason of inclusion	New medicine (specialité)
Main indication	Stomach cancer
Extended indication	previously untreated locally advanced unresectable or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinoma
Manufacturer	Arcus
Mechanism of action	Other, see general comments
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)
Additional remarks	Werkingsmechanisme: A humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting the co-inhibitory molecule and immune checkpoint inhibitor T-cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibitory motif (ITIM) domains (TIGIT), with potential immune checkpoint inhibitory activity.

Registration

Registration route	Centralised (EMA)
ATMP	No
Submission date	2024
Expected Registration	2025
Orphan drug	No
Registration phase	Clinical trials

Therapeutic value

Therapeutic value	No estimate possible yet
Substantiation	Op dit moment loopt de studie nog.
Frequency of administration	1 times every 3 weeks
References	NCT05568095

Expected patient volume per year

Patient volume	< 532 Market share is generally not included unless otherwise stated.
References	NKR2021 (1);
Additional remarks	De incidentie van maagcarcinoom betrof 1.109 (1) patiënten, waarbij 48% procent sprake is van palliatief stadium. Er wordt ervan uitgegaan dat dit uitsluitend adenocarcinoom omvat. In de studie zijn ook patiënten met GEJ geïncludeerd, maar een accurate inschatting van de omvang van deze groep is lastig te maken. Dit is echter significant lager dan het gedeelte met maagcarcinoom.

Patient volume

< 532

Market share is generally not included unless otherwise stated.

References

NKR2021 (1);

Additional remarks

De incidentie van maagcarcinoom betrof 1.109 (1) patiënten, waarbij 48% procent sprake is van palliatief stadium. Er wordt ervan uitgegaan dat dit uitsluitend adenocarcinoom omvat. In de studie zijn ook patiënten met GEJ geïncludeerd, maar een accurate inschatting van de omvang van deze groep is lastig te maken. Dit is echter significant lager dan het gedeelte met maagcarcinoom.

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

Indication extension	Yes
Indication extensions	Zie indicatie-uitbreiding voor NSCLC die opgenomen is op de Horizonscan
References	AdisInsight

Other information

There is currently no futher information available.