Ensartinib

Extended indication	Patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.
Therapeutic value	Possible equal value
Registration phase	Clinical trials

Product

Active substance	Ensartinib
Domain	Oncology and Hematology
Reason of inclusion	New medicine (specialité)
Main indication	Lung cancer
Extended indication	Patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.
Manufacturer	Betta Pharmaceuticals
Mechanism of action	Other, see general comments
Route of administration	Oral
Therapeutical formulation	Capsule
Budgetting framework	Intermural (MSZ)
Additional remarks	Anaplastic lymphoma kinase inhibitors; EphA2 receptor antagonist; Proto oncogene protein c met inhibitor; ROS1 protein inhibitors; TrkA receptor antagonist; TrkC receptor antagonist.

Registration

Registration route	Centralised (EMA)
Submission date	2021
Expected Registration	2022
Orphan drug	No
Registration phase	Clinical trials
Additional remarks	Indieningsdatum op basis van primary completion datum fase 3 studie in maart 2021.

Therapeutic value

Current treatment options	Lorlatinib en alectinib.
Therapeutic value	Possible equal value
Substantiation	Er wordt verwacht dat ensartinib een plaats zal krijgen naast de twee huidige behandelopties en dat de markt verdeeld zal worden. Uit de resultaten van de trial kwam een mediane PFS van 25,8 maanden (95% CI, 21.8–not reached [NR]) versus 12.7 maanden (95% CI, 9.2-6.6) in de (ITT) populatie (hazard ratio [HR], 0.51; 95% CI, 0.35-0.72; P = .0001).
Dosage per administration	225mg
References	NCT02767804

Expected patient volume per year

Patient volume	< 141 Market share is generally not included unless otherwise stated.
References	NKR; Pakketadvies Atezolizumab; Korpanty et al. Front Oncol. 2014; 4: 204.; GIPdatabank; Tiseo et al. Lung Cancer. 2011 Feb;71(2):241-3.; record brigatinib.
Additional remarks	In 2018 waren er 5.062 patiënten met NSCLC stadium IV. Hiervan is 5% ALK+ (225). Aannemende dat 70% getest wordt (158), 20% van de ALK+ patiënten geïncludeerd wordt in studies, en 80% van de resterende patiënten een eerstelijns ALK TKI krijgen (141). De verwachting is dat de markt verdeeld zal worden over lorlatinib, alectinib en ensartinib.

Patient volume

< 141

Market share is generally not included unless otherwise stated.

References

NKR; Pakketadvies Atezolizumab; Korpanty et al. Front Oncol. 2014; 4: 204.; GIPdatabank; Tiseo et al. Lung Cancer. 2011 Feb;71(2):241-3.; record brigatinib.

Additional remarks

In 2018 waren er 5.062 patiënten met NSCLC stadium IV. Hiervan is 5% ALK+ (225). Aannemende dat 70% getest wordt (158), 20% van de ALK+ patiënten geïncludeerd wordt in studies, en 80% van de resterende patiënten een eerstelijns ALK TKI krijgen (141). De verwachting is dat de markt verdeeld zal worden over lorlatinib, alectinib en ensartinib.

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	CNS cancer; Malignant melanoma; Non-Hodgkin's lymphoma; Solid tumours
References	Adis insight

Other information

There is currently no futher information available.