Extended indication 2nd or 3rd Line in HLA-A2 Positive Patients With Advanced NSCLC After Failure of Immune Checkpoint I
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Tedopi
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Lung cancer
Extended indication 2nd or 3rd Line in HLA-A2 Positive Patients With Advanced NSCLC After Failure of Immune Checkpoint Inhibitor.
Manufacturer OSE Pharma
Mechanism of action Other, see general comments
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments Cytotoxic T lymphocyte stimulants

Registration

Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials
Additional comments Indieningsdatum gebaseerd op primary completion datum in december 2021.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Op dit moment zijn er resultaten van een follow up van 12 maanden bij 100 patiënten. De effectiviteit zal nog verder aangetoond moeten worden.
Frequency of administration 1 times every 3 weeks
Dosage per administration 1 mL
References NCT02654587 (ATALANTE 1)
Additional comments OSE2101 will be administered as a 1 mL-subcutaneous injection on Day 1 every three weeks for six cycles, then every eight weeks for the remainder of year one and finally every twelve weeks beyond year one until unequivocal RECIST 1.1-defined disease progression as determined by the investigator, unacceptable toxicity, or consent withdrawal.

Expected patient volume per year

Patient volume

500 - 1,000

Market share is generally not included unless otherwise stated.

References NKR 2018; Richtlijn niet-kleincellig longcarcinoom, NVALT 2020; Expertopinie; Pakketadvies sluisgeneesmiddel atezolizumab (Tecentriq®) bij gemetastaseerde niet-kleincellige longkanker, ZIN 2018; Mezquita et al. Lung Cancer. 2017 Oct;112:10-15.
Additional comments In 2018 waren er 10.190 diagnoses NSCLC in Nederland, hiervan heeft 10% stadium IIIb (1.090), 50% stadium VI (5.095). Hier komen nog patiënten bij uit eerdere stadia die verslechteren naar stadium IIIb/IV. Binnen een jaar is de inschatting dat dit 20% van stadium I/II bedraagt (529) en 50% van stadium IIIa (713). In totaal bedraagt deze groep dus 7.427 patiënten. In 2018 kregen 4.825 patiënten met NSCLC systemische therapie (65%). Ongeveer 45% van de patiënten met een systemische behandeling in de eerste lijn zal in aanmerking komen voor een tweedelijnsbehandeling (2.173). Ongeveer 48% van de tumoren is HLA-A2 positief (1.043). Er wordt verwacht dat er uiteindelijk 500-1.000 patiënten in aanmerking kunnen 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

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Adis insight
References Breast cancer; Colorectal cancer; Ovarian cancer; Pancreatic cancer; Prostate cancer

Other information

There is currently no futher information available.