OBJECTIVES: The National Institute of Health and Care Research Innovation Observatory undertook a pipeline analysis to deliver insight needed to support decisions about the reality and impact of adopting license extensions for three immuno-oncology medicines, supporting decision making within NHS England. This project aimed to provide a robust horizon scan of three specified immune-oncology medicines and their indications in clinical development, supporting operational preparation and efficiency in topic selection, and assist indication-based pricing through a strategic policy lens.

METHODS: The Innovation Observatory maintains an internally facing Medicines Innovation Database (MInD), a comprehensive database consisting of innovative health technology records identified through robust horizon scanning methodology, focusing on those with potential to be licensed in the United Kingdom (UK) within five years. Records contain fields such as target indication(s), patient population(s), and associated trials. The project included records from MInD containing pembrolizumab, nivolumab, or atezolizumab, and excluded those with non-oncology indications, phase I trials, and those with no plans to launch in the UK. Data were extracted May 2022.

RESULTS: A total of 1152 records containing 1225 unique clinical trials met the initial inclusion criteria. Pembrolizumab made up the largest proportion of records (43%), followed by nivolumab (38%), then atezolizumab (19%). Lung cancers were the therapeutic area most widely studied. Combinations were significantly more investigated than monotherapies across all therapeutic areas. 47% of records listed phase II trials as the highest level of clinical development, 21% phase III. Metastatic cancers and first-line treatments were most currently being studied at phase III. 18% of records have estimated license dates within five years.

CONCLUSIONS: The horizon scan identified areas of significant development activity for the immuno-oncology medicines which will help to influence preparation for future licensing reviews and policy decision making, improving the efficiency of the process, and potentially reducing time to market.