Sistema de Salut de Catalunya
Institut Català de la Salut
[Haakensen VD] Dept of Oncology, Oslo University Hospital, Oslo, Norway. Dept of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway. Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway. [Öjlert ÅK, Thunold S, Farooqi S] Dept of Oncology, Oslo University Hospital, Oslo, Norway. Dept of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway. [Nowak AK] Medical School of The University of Western Australia, Western Australia, Australia. National Centre for Asbestos-Related Diseases, University of Western Australia, Australia. Sir Charles Gairdner Hospital, Western Australia, Australia. [Chin WL] National Centre for Asbestos-Related Diseases, University of Western Australia, Australia. Sir Charles Gairdner Hospital, Western Australia, Australia. [Cedres S] Vall d′Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d′Hebron Hospital Universitari, Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus
2024-03-14T09:47:23Z
2024-03-14T09:47:23Z
2024-03-01
Immunotherapy; Pleural mesothelioma; Telomerase vaccine
Immunoteràpia; Mesotelioma pleural; Vacuna de telomerasa
Inmunoterapia; Mesotelioma pleural; Vacuna de telomerasa
Purpose The NIPU-trial investigates the effect of adding the telomerase vaccine UV1 to treatment with ipilimumab and nivolumab for patients with pleural mesothelioma (PM). Methods In this phase 2 open-label trial, patients with PM progressing after first-line chemotherapy were randomised to receive ipilimumab and nivolumab alone (arm B) or combined with UV1 (arm A). The primary endpoint was progression-free survival (PFS) as determined by BICR. It was estimated that 69 PFS events were needed to detect a hazard ratio (HR) of 0.60 with 80% power and a one-sided alpha level of 0.10. Results 118 patients were randomised. The median PFS determined by blinded independent central review (BICR) was 4.2 months (95%CI 2.9–9.8) in arm A and 4.7 months (95%CI 3.9–7.0) in arm B (HR 1.01, 80%CI 0.75–1.36 P = 0.979), after a median follow-up of 12.5 months (95%CI 9.7–15.6). The investigator-determined median PFS was 4.3 months (95%CI 3.0–6.8) in arm A and 2.9 months (95%CI 2.4–5.5) in arm B (HR 0.60, 80%CI 0.45–0.81 P = 0.025). Confirmed objective response rate (ORR) by BICR was 31% in arm A and 16% in arm B (odds ratio 2.44 80%CI 1.35–4.49 P = 0.056). After a median follow-up time of 17.3 months (95%CI 15.8–22.9), the OS was 15.4 months (95%CI 11.1–22.6) in arm A and 11.1 months (95%CI 8.8–18.1) in arm B, (HR 0.73, 80%CI 0.53–1.0, P = 0.197). Conclusion The primary endpoint was not met. Predefined analyses of response rates are in favour of adding the vaccine.
The trial was researcher-initiated and funded by grants from the South-Eastern Norway Regional Health Authorities (grant number 2020077 and 2021083). Study medication was provided by Ultimovacs and Bristol Myers Squibb. Ultimovacs also provided funding for study procedures.
Article
Published version
English
Pleura - Càncer - Tractament; Quimioteràpia combinada; Mesotelioma - Tractament; DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Glandular and Epithelial::Adenoma::Mesothelioma; DISEASES::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Pleural Neoplasms; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols; ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias glandulares y epiteliales::adenoma::mesotelioma; ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pleurales; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada
Elsevier
European Journal of Cancer;202
https://doi.org/10.1016/j.ejca.2024.113973
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
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