Extended indication Patients with stage III/IV metastatic melanoma who have failed or are failing on anti-PD-1 therapies
Therapeutic value No estimate possible yet
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
Budgetting framework Intermural (MSZ)
Additional comments Tavokinogene telsaplasmid codeert voor IL-12, een immunostimulant. Electroporatie via ImmunoPulse is benodigd voor de activatie van tavokinogene telsaplasmid in het tumorweefsel.

Registration

Registration route Centralised (EMA)
ATMP Yes
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials
Additional comments Heeft een wees status bij de FDA.

Therapeutic value

Therapeutic value No estimate possible yet
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 (200mg) op dag 1 van iedere 3-weekse cyclus gedurende 17 tavo-EP cycli en 33 pembrolizumab cycli.

Expected patient volume per year

Patient volume

< 744

Market share is generally not included unless otherwise stated.

References NKR
Additional comments Melanoom van de huid betreft 6.729 patiënten in 2018, hiervan zijn er 541 patiënten met stadium 3 en 203 patiënten met stadium 4 (maximaal 744 patiënten die in aanmerking komen voor deze behandeling.)

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

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

Indication extension

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

Other information

There is currently no futher information available.