Durvalumab Medicine 04 December 2025 Extended indication A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy. PACIFIC-9. Therapeutic value No estimate possible yet Total cost € 54,000,000.00 Registration phase Clinical trials Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy. PACIFIC-9. Current proprietary name Already available biosimilars / generics Proprietary name Imfinzi Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date September 2026 Expected Registration November 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Broadly excluded Additional remarks Therapeutic value Current treatment options Durvalumab monotherapie Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De studie loopt nog tot medio 2026. Wel was er de fase 2 COAST trial, waaruit de volgende resultaten kwamen: beide combinaties verlengden de progressievrije overleving (PFS) vergeleken met durvalumab alleen (met oleclumab: hazard ratio [HR] 0,59 [95% BI 0,37–0,93]; met monalizumab: HR 0,63 [95% BI 0,40–0,99]), maar toonden geen statistisch significante verbanden met een langere algehele overleving (met oleclumab: HR 0,69 [95% BI 0,40–1,20]; met monalizumab: HR 0,77 [95% BI 0,44–1,33]). De veiligheid was vergelijkbaar tussen de behandelarmen, zonder nieuwe of opvallende veiligheidsproblemen. Duration of treatment Frequency of administration Dosage per administration References NCT05221840 (PACIFIC-9) Additional remarks Durvalumab op dag 1 van elke 28-daagse cyclus plus Oleclumab op dag 1 en 15 van cyclus 1 en 2, daarna op dag 1 van elke daaropvolgende 28daagse cyclus, gedurende maximaal 12 maanden. Durvalumab plus Monalizumab op dag 1 van elke 28daagse cyclus, gedurende maximaal 12 maanden. Een placebo-infusie wordt toegediend op dag 15 van cyclus 1 en 2 alleen. Expected patient volume per year Patient volume < 800 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2022 (1); Agbarya et al. JCM. 2022 (2); Antonia et al. NEJM. 2017 (3). Additional remarks In 2022 waren er 2.247 gevallen van stadium 3 niet kleincellig longcarcinoom in Nederland (1). Ongeveer 70% van de patiënten in stadium 3 is niet-resectabel (n=1.573) (2). Ongeveer de helft van de stadium 3 niet-resectabele patiënten cCRT ondergaat daadwerkelijk cCRT (n~800) (3). Expected cost per patient per year Cost € 45,000.00 - 90,000.00 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. References medicijnkosten.nl Additional remarks De prijs per 2,4 mL flacon (50mg/ml) durvalumab (Imfinzi) is €444. De jaarlijkse kosten zijn afhankelijk van de dosering en behandelduur. Inschatting: in lijn met andere indicaties. Deze kosten betreffen alleen durvalumab. Potential total cost per year Total cost € 54,000,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks