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NY-ESO-1 autologous engineered TCR-T cells

Extended indication

Relapsed and Refractory Synovial Sarcoma Expressing New York Esophageal Antigen-1 (NY-ESO-1) and/or

Therapeutic value

No estimate possible yet
Registration phase

Clinical trials

Product

Active substance

NY-ESO-1 autologous engineered TCR-T cells
Domain

Oncology
Reason of inclusion

New medicine (specialité)
Main indication

Oncology other
Extended indication

Relapsed and Refractory Synovial Sarcoma Expressing New York Esophageal Antigen-1 (NY-ESO-1) and/or LAGE-1a.
Manufacturer

GSK
Mechanism of action

Autologous modified cell therapy
Route of administration

Intravenous
Therapeutical formulation

Intravenous drip
Budgetting framework

Intermural (MSZ)
Additional remarks 
NY-ESO-1 autologous engineered TCR-T cells (engineered TCR).

Registration

Registration route

Centralised (EMA)
Type of trajectory

Accelerated assessment
Particularity

New medicine with Priority Medicines (PRIME)
ATMP

Yes
Submission date

July 2023
Expected Registration

April 2024
Orphan drug

Yes
Registration phase

Clinical trials

Therapeutic value

Current treatment options

Bestraling en chemotherapie.
Therapeutic value

No estimate possible yet
Duration of treatment

one-off
Dosage per administration

1 tot 6 x10^9 cellen
References 
NCT03697824
Additional remarks 
De fase 2 studie NCT03697824 is teruggetrokken en wordt vervangen door een studie naar monotherapie.

Expected patient volume per year

Patient volume

5

Market share is generally not included unless otherwise stated.
References 
NKR;
https://mens-en-gezondheid.infonu.nl/aandoeningen/187822-synoviaal-sarcoom-kanker-van-weefsel-rond-gewrichten.html#behandeling;
Lai et al. Oncoimmunology. 2012 Nov 1; 1(8): 1409–1410.
Additional remarks 
In 2016 waren er 34 wekedelen sarcomen van de extremiteiten gediagnosticeerd, waar het synoviaal carcinoom er een van is. De incidentie van dit synoviaal carcinoom wordt geschat op 1 in de 3 miljoen, ongeveer 6 per jaar in Nederland. Expressie van NY-ESO-1 komt voor in ongeveer 80% van de gevallen van synoviaal sarcoom (5 patiënten).

Expected cost per patient per year

Additional remarks 
Gezien de PRIME-status zal deze behandeling waarschijnlijk hoge kosten met zich meebrengen.

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

Gastrointestinal cancer, Malignant melanoma, Multiple myeloma, Non-small cell lung cancer, Ovarian cancer, Liposarcoma.
References 
AdisInsight

Other information

There is currently no futher information available.