Toripalimab

Extended indication	Toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (“NPC”)
Therapeutic value	No estimate possible yet
Total cost	3,800,000.00
Registration phase	Registration application pending

Product

Active substance	Toripalimab
Domain	Oncology
Reason of inclusion	New medicine (specialité)
Main indication	Oncology other
Extended indication	Toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (“NPC”)
Manufacturer	Shanghai Junshi
Portfolio holder	Shanghai Junshi
Mechanism of action	PD-1 / PD-L1 inhibitor
Route of administration	Intravenous
Therapeutical formulation	Injection
Budgetting framework	Intermural (MSZ)

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	December 2022
Expected Registration	February 2024
Orphan drug	Yes
Registration phase	Registration application pending

Therapeutic value

Therapeutic value	No estimate possible yet
Substantiation	In de interim PFS analyse werd een verbetering van de PFS gezien in de toripalimab arm vergeleken met de placebo arm: een mediane PFS van 11,7 versus 8 maanden, hazard ratio (HR) = 0,52 (95% confidence interval (CI): 0.36–0.74), P = 0.0003 (1). De data van de fase III studie is ook beschikbaar, JUPITER02. Op ASCO 23 werden de voorlopige OS data gepresenteerd: de mediane survival follow up was 30,1 maanden. Een significante verbetering van de OS werd gezien voor de patiënten die met toripalimab werden behandeld ten opzichte van placebo: HR = 0,63 (95% CI: 0.45-0.89), two-sided p = 0.0083. De mediane OS werd niet gehaald in de toripalimab arm en was 33,7 maanden in de placebo arm. De studie is echter in China uitgevoerd en het is nog de vraag of dit ook representatief is voor de Europese bevolking.
Frequency of administration	1 times every 3 weeks
Dosage per administration	240 mg
References	NCT03581786, NCT02915432; Nature Medicine volume 27, pages 1536–1543 (2021) (1);

Expected patient volume per year

Patient volume	< 95 Market share is generally not included unless otherwise stated.
References	NKR 2021 (1)
Additional remarks	In 2021 waren er 95 patiënten met NPC (1).

Patient volume

< 95

Market share is generally not included unless otherwise stated.

References

NKR 2021 (1)

Additional remarks

In 2021 waren er 95 patiënten met NPC (1).

Expected cost per patient per year

Cost	30,000.00 - 50,000.00
References	GIP databank
Additional remarks	Mogelijk vergelijkbaar met andere PD1 remmers

Potential total cost per year

Total cost	3,800,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Total cost

3,800,000.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension	Yes
Indication extensions	Meedere fase 3 studies (zie AdisInsight), nu momenteel 3 indicaties opgenomen hiervan op de Horizonscan (NSCLC, NPC en ESCC)
References	Adis Insight

Other information

There is currently no futher information available.