Extended indication In Combination With BCG in patients with Unresponsive High Grade Non-Muscle Invasive Bladder Cancer.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Inbakicept
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Bladder cancer
Extended indication In Combination With BCG in patients with Unresponsive High Grade Non-Muscle Invasive Bladder Cancer.
Proprietary name Anktiva
Manufacturer ImmunityBio
Route of administration Intravesical
Budgetting framework Intermural (MSZ)
Additional comments Interleukin-15 receptor agonist.

Registration

Registration route Centralised (EMA)
Submission date 2022
Expected Registration 2023
Orphan drug No
Registration phase Clinical trials
Additional comments Primary completion datum fase 3 studie in januari 2023. Breakthrough therapy designation bij de FDA.

Therapeutic value

Current treatment options Pembrolizumab
Therapeutic value No estimate possible yet
Substantiation De eerste interim resultaten van studie NCT03022825 bij patiënten met BCG unresponsive high grade NMIBG zijn inmiddels gepresenteerd op de ASCO GU 2021. Het eindpunt is gehaald.
References NCT03022825
Additional comments All patients treated in the study will receive via a urinary catheter in the bladder, BCG plus N-803 or N-803 only weekly for 6 consecutive weeks (initial induction treatment period). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36. The study duration is 60 months.

Expected patient volume per year

Patient volume

< 1,500

Market share is generally not included unless otherwise stated.

References NKR2018(1); IKNL(2);
Additional comments Totaal aantal patiënten met invasief blaaskanker: 3.220 (1). De inschatting is dat hiervan ongeveer 1.500 patiënten gediagnosticeerd worden met hooggradig niet-spierinvasief blaascarcinoom (HG-NMIBC). Een deel hiervan krijgt BCG spoeling na een transurethrale resectie van de blaas. Nadere toelichting schatting 1.500 patiënten: In de afgelopen jaren kregen zo’n 700 patiënten met een in situ of T1 tumor een BCG-spoeling en zo'n 850 patiënten met een hooggradige tumor (2). Aangezien het hier om 'unresponsive' (Persistent or recurrent) patiënten gaat zal het patiëntvolume lager uitvallen.

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
References adisinsight
Additional comments Non-small cell lung cancer.

Other information

There is currently no futher information available.