Monitoring CAR-T-Cell Therapies Using the Nordic Healthcare Databases
- PDF / 585,072 Bytes
- 6 Pages / 595.276 x 790.866 pts Page_size
- 14 Downloads / 228 Views
CURRENT OPINION
Monitoring CAR‑T‑Cell Therapies Using the Nordic Healthcare Databases Torbjörn Callréus1 · Tarec Christoffer El‑Galaly2 · Mats Jerkeman3 · Peter de Nully Brown4 · Morten Andersen1 Published online: 13 March 2019 © Springer Nature Switzerland AG 2019
Abstract Following intense research efforts, modulation of the immune system has finally proved to be a viable approach for treating malignant disease. Recently, chimeric antigen receptor redirected T cells have achieved promising outcomes in patients with B-cell malignancies and they are currently also being investigated in other haematological malignancies, solid tumours and viral infections. Compared with traditional biopharmaceuticals, the properties of genetically modified chimeric antigen receptor redirected T-cell therapies differ in many aspects, thereby posing challenges in terms of post-authorisation data collection and data analysis. We believe that the network of population-based Nordic healthcare databases has some characteristics that can help provide important data on these new types of advanced products. In particular, the possibility of very long follow-up periods with a limited loss to follow-up is an important strength. Given the limited source population and slow access to data, a Nordic chimeric antigen receptor redirected T-cell monitoring project should be seen as complementary to other surveillance initiatives. Key Points Treatment with chimeric antigen receptor redirected T cells (CAR-T cells) has achieved promising outcomes in patients with B-cell malignancies. The properties of this new treatment modality present challenges in terms of post-authorisation data collection and data analysis The network of population-based Nordic healthcare databases has some features that can help provide important safety and efficacy data on these products. The opportunity of very long follow-up periods with a limited loss to follow-up is an important strength The Nordic healthcare databases have limitations in terms of a limited source population and slow access to data; they should therefore be seen as complementary to other data sources * Torbjörn Callréus [email protected] 1
Department of Drug Design and Pharmacology, University of Copenhagen, Jagtvej 160, 2100 Copenhagen, Denmark
2
Department of Hematology, Aalborg University Hospital, Aalborg, Denmark
3
Department of Oncology, Lund University, Lund, Sweden
4
Department of Hematology, Copenhagen University Hospital, Copenhagen, Denmark
1 Introduction Following intense research efforts, modulation of the immune system has finally proved to be a viable approach for treating malignant disease [1]. The first class of products with this mechanism of action were the immune checkpoint inhibitors that included drugs acting on the cytotoxic T-lymphocyte-associated protein 4 (ipilimumab) and programmed cell death protein 1 (nivolumab). More recently, chimeric antigen receptor redirected T cells (CAR-T cells) have achieved promising outcomes in patients with B-cell
Data Loading...
