Extended indication Jemperli is indicated as monotherapy for the Treatment of adult patients with recurrent or advanced
Therapeutic value No estimate possible yet
Total cost 1,192,500.00
Registration phase Registered

Product

Active substance Dostarlimab
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Other oncology
Extended indication Jemperli is indicated as monotherapy for the Treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum‑containing regimen.
Proprietary name Jemperli
Manufacturer GSK
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Submission date March 2020
Expected Registration April 2021
Orphan drug No
Registration phase Registered
Additional comments Positieve CHMP-opinie in februari 2021.

Therapeutic value

Current treatment options In de tweede lijn wordt voor immunotherapie bijvoorbeeld Megestrol of Medroxyproges-teron acetaat (MPA) toegediend.
Therapeutic value No estimate possible yet
Substantiation Fase 1-2 Garnet trial SGO annual meeting 2019 ORR rond 50%, maar nog geen andere studies gepubliceerd. Combinatie studie loopt.
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 cycli gevolgd door 1.000mg iedere 6 weken. De fabrikant geeft aan dat de GARNET studie een fase 1-2 studie is.

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%-20%. Dit zou betekenen dat 18-35 patiënten mogelijk in aanmerking komen voor deze behandeling.

Expected cost per patient per year

Cost 30,000.00 - 60,000.00
References G-standaard
Additional comments De kosten zullen waarschijnlijk vergelijkbaar zijn met de PD-L1 remmer olaparib.

Potential total cost per year

Total cost

1,192,500.00

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.

Off label use

There is currently nothing known about off label use.

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.

Other information

There is currently no futher information available.