Inbakicept Medicine 07 June 2022 Extended indication In Combination With BCG in patients with Unresponsive High Grade Non-Muscle Invasive Bladder Cancer. Therapeutic value No estimate possible yet Total cost 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. Current proprietary name Already available biosimilars / generics Proprietary name Anktiva Manufacturer ImmunityBio Portfolio holder Mechanism of action Unknown Route of administration Intravesical Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Interleukin-15 receptor agonist. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2023 Expected Registration 2024 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks 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 This assessment does not indicate any potential inclusion in the package. 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. Duration of treatment Frequency of administration Dosage per administration References NCT03022825 Additional remarks 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. Maximum patient volume for sluice References NKR2018(1); IKNL(2); Additional remarks 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 Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions References adisinsight Additional remarks Non-small cell lung cancer. Other information Additional remarks