Tavokinogene telseplasmid

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.
Therapeutic value	No judgement
Registration phase	Clinical trials

Product

Active substance	Tavokinogene telseplasmid
Domain	Oncology and Hematology
Reason of inclusion	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.
Proprietary name	Tavo
Manufacturer	OncoSec
Mechanism of action	Immunostimulation
Route of administration	Intratumoral
Therapeutical formulation	Injection
Additional remarks	Tavokinogene telsaplasmid codeert voor IL-12, een immunostimulant. Electroporatie via ImmunoPulse is benodigd voor de activatie van tavokinogene telsaplasmid in het tumorweefsel.

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

Therapeutic value	No judgement
References	NCT03132675
Additional remarks	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. .

Patient volume	< 474 Market share is generally not included unless otherwise stated.
References	NKR
Additional remarks	Melanoom van de huid betreft 6.929 patiënten in 2016. Hiervan zijn er 419 patiënten met stadium 3 en 55 patiënten met stadium 4.

Patient volume

< 474

Market share is generally not included unless otherwise stated.

References

NKR

Additional remarks

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

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

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

There is currently no futher information available.