Tavokinogene telseplasmid

Active substance
Tavokinogene telseplasmid
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Skin cancer
Extended indication
Patients with stage III/IV metastatic melanoma who have failed or are failing on anti-PD-1 therapies (like nivolumab and pembrolizumab) in combination with pembrolizumab.

1. Product

Proprietary name
Tavo
Manufacturer
OncoSec
Mechanism of action
Immunostimulation
Route of administration
Intratumoral
Therapeutical formulation
Injection
Additional comments
Tavokinogene telsaplasmid codeert voor IL-12, een immunostimulant. Electroporatie via ImmunoPulse is benodigd voor de activatie van tavokinogene telsaplasmid in het tumorweefsel.

2. Registration

Registration route
Centralised (EMA)
Submission date
2020
Expected Registration
2021
Registration phase
Clinical trials
Additional comments
Dit geneesmiddel is geclassificeerd als een ATMP. Heeft orphan status bij de FDA.

3. Therapeutic value

Therapeutic value
No judgement
Duration of treatment
Not found
References
NCT03132675
Additional comments
Patiënten worden behandeld met intratumorale tavo-EP op dagen 1, 5 en 8 iedere 6 weken en met intraveneuze toediening van pembrolizumab (200 mg) op dag 1 van iedere 3-weekse cyclus gedurende 17 tavo-EP cycli en 33 pembrolizumab cycli. .

4. Expected patient volume per year

Patient volume

< 474

Market share is generally not included unless otherwise stated.

References
NKR
Additional comments
Melanoom van de huid betreft 6.929 patiënten in 2016. Hiervan zijn er 419 patiënten met stadium 3 en 55 patiënten met stadium 4.

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

Off label use
Yes
Indications off label use
Melanoma patients with immunologically cold tumors; eoadjuvant resectable melanoma; R/R squamous cell carcinoma of the head and neck (SCCHN); triple negative breast cancer (TNBC)
References
OncoSec pipeline

8. Indication extension

Indication extension
No
References
adisinsght
Additional comments
Geen lopende fase 3 studies.

9. Other information

There is currently no futher information available.