Dostarlimab

Active substance
Dostarlimab
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Other oncology
Extended indication
Monotherapy in women with advanced or recurrent MSI-H and MSS endometrial cancer who progressed on or after a platinum-based regimen.

1. Product

Manufacturer
GSK
Mechanism of action
PD-1 / PD-L1 inhibitor
Route of administration
Intravenous
Therapeutical formulation
Intravenous drip
Budgetting framework
Intermural (MSZ)

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Accelerated assessment
Submission date
April 2020
Expected Registration
April 2021
Orphan drug
No
Registration phase
Registration application pending
Additional comments
De fabrikant verwacht indiening in de eerste helft van 2020 en registratie in de eerste helft van 2021.

3. Therapeutic value

Current treatment options
In de tweede lijn wordt voor immunotherapie bjivoorbeeld Megestrol of Medroxyproges-teron acetaat (MPA) toegedient.
Therapeutic value
No judgement
Duration of treatment
Not found
Frequency of administration
1 times every 3 weeks
Dosage per administration
500 mg tot 1000 mg
References
NCT02715284
Additional comments
500mg per 3 weken voor de eerste 4 cycles gevolgd door 1.000mg iedere 6 weken. De fabrikant geeft aan dat de GARNET studie een fase 1/2 studie is.

4. Expected patient volume per year

Patient volume

18 - 35

Market share is generally not included unless otherwise stated.

References
NKR; Follow-up after primary therapy for endometrial cancer: a systematic review. Fung-Kee-Fung. Gynecol Oncol. 2006 Jun;101(3):520-9. Epub 2006 Mar 23.; Sorbe B, Juresta C, Ahlin C. Natural history of recurrences in endometrial carcinoma. Oncol Lett. 2014;8(4):1800–1806. doi:10.3892/ol.2014.2362
Additional comments
Er waren in 2015 in totaal 1.931 patiënten met een endometriumcarcinoom. Daarvan betrof het in 177 gevallen een carcinoom van stadium 4. De recurrence rate voor endometrium carcinoom bedraagt ongeveer 10 tot 20%. Dit zou betekenen dat 18 tot 35 patiënten mogelijk in aanmerking komen voor deze behandeling.

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
Yes
Indication extensions
Fallopiantube, ovarian and peritoneal cancer.
References
clinicaltrials.gov
Additional comments
Op dit moment lopen er meerdere fase 3 studies naar boven genoemde indicaties.

9. Other information

There is currently no futher information available.