Talimogene laherparepvec (Amgen), or T-VEC for short, was the first Oncolytic virus to be approved by the European Medicines Agency (December 2015). T-VEC is a modified form of the herpes virus and kills cancer cells in two ways — by attacking them directly and by directing the patient’s own immune system against the tumour. It is genetically modified to preferentially replicate in tumour cells and to express granulocyte-macrophage colony-stimulating factor (GM-CSF) which stimulates the immune system to attack and destroy the tumour.
Currently, adults with melanoma that cannot be removed by surgery and that has spread locally or around the body qualify to receive the treatment.
Leeds Teaching Hospitals NHS Trust (LTHT), member of the Northern Alliance ATTC has a significant track record in the use of oncolytic viruses in clinical trials. Leeds was chosen as a commissioned provider to deliver this new clinical service. It has recently started delivering T-VEC as a commissioned service, outside the usual frameworks and support provided for research programmes. This work revealed a number of internal factors that had to be taken into consideration when delivering such products outside the highly regulated confines of a clinical trial, including:
- Approval process for non-trial GMOs (licensed commissioned products)
- Agreement for treatment delivery of GMOs in non-research clinical areas
- Training of medical, nursing and pharmacy staff around product place in therapy, procurement, handling, storage, spillage, disposal, administration and approval processes
- Appropriate low temperature storage facilities and monitoring
To overcome these, a new SOP had to be written for the Biological Safety Committee to approve the use of such products, a pharmacy SOP had to be written for receipt of product, storage and dispensing, an internal logistics pathway set up with the clinical melanoma team, a training programme developed for GMO handing requirements for non-research staff and wider briefings about the new service held so that all staff involved in care of melanoma patients were informed about the new service.
Leeds ATMP Pharmacist, Sarah Tehan, who led the work commented “This work has revealed the significant differences between delivering ATMP’s in clinical trials and as commissioned service. A significant amount of cross-organisation work has been required to set up this service, even with the significant learning we had from using the product in clinical trials. What we have learnt will be useful with our work in other areas going forwards”.
The TVEC service is operational with 3 patients currently on treatment. This is the first licensed ATMP approved for use in LTHT and the lessons learnt from this experience are being applied to work being undertaken at the organisation developing pathways for delivering CAR-T therapies and other ATMP’s, both in a research environment and as a commissioned service, to try and minimise the amount of process reinvention required when moving from research to clinical service.